helvella - Eltroxin vs Levothyroxine

Note: The markings on Advanz Pharma/Mercury levothyroxine tablets have changed since this correspondence - but the tablets have the same formulation.

Since Advanz Pharma (whether under their own name or their subsidiary Mercury Pharma) have been marketing both the branded Eltroxin and generic Levothyroxine - in the same dosages - many have asked if there is any difference.

The simple answer is "No! - there is no difference".

However, this is a question that both should be asked and needs a clear answer. I asked both Advanz and the MHRA back in 2013 for clarification. This is the email I received from Advanz on 14/09/2020:

Dear [ helvella ],

Thank you for contacting ADVANZ PHARMA requesting clarification regarding Eltroxin branded and Mercury Pharma branded Levothyroxine marketed in the UK by ADVANZ PHARMA.

As you are aware the products below share the same product license (PL) number, therefore are of the same specification/formulation:

Eltroxin 25mcg tablets (PL 12762/0016)

Levothyroxine 25mcg tablets (PL 12762/0016)

Eltroxin 50mcg tablets (PL 10972/0031)

Levothyroxine 50mcg tablets (PL 10972/0031)

Eltroxin 100mcg tablets (PL 10972/0032)

Levothyroxine 100mcg tablets (PL 10972/0032)

The relevant department have also confirmed that both of the aforementioned products are available.

The generic Levothyroxine tablets are available as a bulk pack and 28 pack size whilst the Eltroxin brand is available only in a 28 pack size.

I hope you find this information useful and helps with your query.

[ deleted boilerplate text ]

Regards,

Gurjit Lidder

Medical Information Executive

I also found the response received from the MHRA 26/03/2014. Please note that this is, at time of posting, almost ten years old. Therefore some details might no longer be exactly as stated - though the licence numbers are the same now.

Dear [ helvella ],

 

Thank you for your correspondence regarding Levothyroxine/Eltroxin tablets supplied by Amdipharm Mercury Company Limited (AMCO) (formerly Mercury Pharma). Please accept my apologies for the length of time you have had to wait for a response.

 

We recently met with AMCo to discuss their levothyroxine licences and the enquiries received from patients regarding the different presentations. We informed them that patient reports (such as yours) indicate that there is confusion for patients about which products are available, and whether products marketed by AMCo as branded Eltroxin or as generic levothyroxine are the same or different.

 

AMCo are now preparing a communication about this for patients and they will issue it in due course.

 

Levothyroxine tablets from AMCo are marketed as either the generic Levothyroxine product or the branded Eltroxin product. In the UK medicinal products are identified by their Product Licence (PL) number which is printed on the product label. The PL numbers of all AMCo levothyroxine products are shown in the table below. It can be seen that all branded (Eltroxin) products manufactured under a particular PL number may alternatively be marketed under the generic name (Levothyroxine). These products are identical in every way. For example “Eltroxin 25 microgram tablets” and “Levothyroxine 25 microgram tablets” that bear PL 12762/0016 on the packaging are identical in every way except for the product labelling.

 

Both the generic and branded AMCo products are available as 25, 50 and 100 microgram strength tablets. The 50 microgram and 100 microgram tablets are each currently available under two different PL numbers. 

 

The 100 microgram tablets marketed under the two different PL numbers are identical. For the 50 microgram strength tablets, there is a very minor difference between products manufactured under PL 10972/0031 and PL 16201/0001 in the amount of powdered acacia (an inactive binder) that the tablets contain. Apart from this, the products are exactly the same. The difference in the amount of powdered acacia is very small (i.e. less than 0.2 %) and is considered very unlikely to affect the performance of the 50 microgram tablets manufactured under the two different PL numbers.

 

To help clear any possible confusion AMCo has recently reviewed the licenses in their product range in consultation with the MHRA. As a result, AMCo have made changes to their licences in order to ensure that the amount of powdered acacia in future batches of the products is the same. Therefore, there will be no difference in the tablet compositions for all future batches of levothyroxine and Eltroxin 50 microgram tablets.

 

AMCo has informed the MHRA that they intend to cease manufacture of levothyroxine 50 microgram tablets under PL 16201/0001 and levothyroxine 100 microgram tablets under PL 16201/0002 and it is expected that supplies of these products will run out by the end of July 2014. Following this AMCo has indicated that no more levothyroxine tablets will be manufactured under these licence numbers.

 

The information in the table below clarifies whether a tablet is labelled as generic or branded and gives the licence number, the tablet markings and the name of the licence holder. Tablets that are identical (except for their names and/or PL numbers) have been grouped together in the table:

 

Product Name(s)	Licence number	Tablet Markings	Licence  Holder
Eltroxin 25 mcg Tablets (Branded)  Levothyroxine 25 mcg tablets (Generic)	PL 12762/0016        PL 12762/0016	FW 41        FW 41	Mercury Pharmaceuticals limited    Mercury pharmaceuticals Limited
Eltroxin 50 mcg Tablets (Branded)    Levothyroxine 50 mcg Tablets (Generic)	PL 10972/0031      PL 10972/0031	FW 21      FW 21	Mercury Pharma Group Limited    Mercury Pharma Group Limited
Levothyroxine 50 mcg Tablets (Generic)*	PL 16201/0001	FW 21	Mercury Pharma Generics Limited
Eltroxin 100 mcg Tablets (Branded)  Levothyroxine 100 mcg Tablets (Generic)   Levothyroxine 100 mcg Tablets (Generic)	PL 10972/0032      PL 10972/0032     PL 16201/0002	FW 31      FW 31     FW 31	Mercury Pharma Group Limited    Mercury Pharma Group Limited   Mercury Pharma Generics Limited

*This product is identical to PL 10972/0031 except for a slight difference in the amount of powdered acacia in current batches. AMCo have now made changes to their licences and there will be no difference in the tablet compositions for all future batches.

 

The manufacturing process for levothyroxine is complex and presents challenges for manufacturers. Each levothyroxine tablet contains a very tiny amount of the active ingredient (less than most other drugs) and has to be manufactured to very high standards as specified by the British Pharmacopoeia. All the tablets have to undergo rigorous quality testing before being released for sale. Since early 2013 AMCo has been experiencing some manufacturing difficulties with levothyroxine tablets. AMCo wanted to make sure that there would be no shortage of levothyroxine tablets and therefore temporarily stopped packing the branded (Eltroxin) product under PL 12762/0016, PL 10972/0031 and PL 10972/0032 in order to pack more of the generic (Levothyroxine) product under the same licence numbers and to produce the generic product under licence numbers PL 16201/0001 and 16201/0002. Consequently, your pharmacist may have been unable to get any supply of tablets labelled as Eltroxin since July 2013.

 

Should a patient be prescribed Eltroxin by a doctor and it is not currently available, the pharmacist will dispense a levothyroxine tablet of the same strength instead, after consultation with the patient’s GP.

 

Should a patient have problems or side effects with their levothyroxine tablets at any time they are advised to contact their doctor. Patients should also report any side effects or problems with their tablets to the MHRA via the Yellow Card Scheme: www.mhra.gov.uk/yellowcard

 

 

We hope this information explains the position with regard to products from AMCo. Official communication for patients from AMCo, as described above, will follow in due course.

 

Please come back to us if you have any further questions, and once again please accept our apologies for the length of time you have had to wait for this response.

 

Kind Regards,

 

 

Ben Scott

Customer Services Manager

Customer Services
External Relations

Medicines and Healthcare Products Regulatory Agency

Note: The tablet markings have changed since that email was received. All dosages have LT on one side and either 25, 50 or 100 on the other side.

For posting in HealthUnlocked, copy and paste the entire dark red text below this sentence.

[i][b]helvella - Eltroxin vs Levothyroxine[/b]

Email evidence that Eltroxin and Levothyroxine tablets are the same product.

Last updated 10/02/2025[/i]

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