FDA Orange Book
Generic for Metadate CD
Metadate CD contains methylphenidate. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Metadate CD is methylphenidate. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2, AB3.
Run it in Rivvi
Map Metadate CD and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Metadate CD products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, extended release, oral | 10MG | Marketed (Rx) | AB2 | 6 | AB2, AB1, AB3 |
| capsule, extended release, oral | 20MG | Marketed (Rx) | AB2 | 6 | AB1, AB2, AB3 |
| capsule, extended release, oral | 30MG | Marketed (Rx) | AB2 | 6 | AB1, AB2, AB3 |
| capsule, extended release, oral | 40MG | Marketed (Rx) | AB2 | 5 | AB1, AB2, AB3 |
| capsule, extended release, oral | 50MG | Marketed (Rx) | AB2 | 3 | AB2, AB3 |
| capsule, extended release, oral | 60MG | Marketed (Rx) | AB2 | 5 | AB2, AB1, AB3 |
NDA 021259, held by LANNETT COMPANY LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic methylphenidate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| DR REDDYS LABORATORIES SA | 078458 | AB1 (A-rated, therapeutically equivalent) | December 1, 2011 | 20MG, 30MG, 40MG, 60MG |
| TEVA PHARMACEUTICALS USA | 077707 | AB2 (A-rated, therapeutically equivalent) | July 19, 2012 | 10MG, 20MG, 30MG |
| SPECGX LLC | 203583 | AB2 (A-rated, therapeutically equivalent) | September 29, 2015 | 10MG, 20MG, 30MG, 40MG, 50MG, 60MG |
| IMPAX LABORATORIES INC | 205105 | AB2 (A-rated, therapeutically equivalent) | July 28, 2016 | 10MG, 20MG, 30MG, 40MG, 50MG, 60MG |
| DR REDDYS LABORATORIES SA | 200886 | AB1 (A-rated, therapeutically equivalent) | February 26, 2018 | 10MG |
| ACTAVIS ELIZABETH LLC | 208861 | AB3 (A-rated, therapeutically equivalent) | December 13, 2018 | 10MG, 20MG, 30MG, 40MG, 50MG, 60MG |
| GRANULES PHARMACEUTICALS INC | 211796 | AB1 (A-rated, therapeutically equivalent) | May 23, 2019 | 10MG, 20MG, 30MG, 40MG, 60MG |
Metadate CD NDC codes
Questions
Is there a generic for Metadate CD?
Yes. The generic name for Metadate CD is methylphenidate. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2, AB3.
What is the generic name for Metadate CD?
The active ingredient in Metadate CD is methylphenidate, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.
More on Metadate CD and Methylphenidate
- What is Metadate CD used for?FDA label uses
- Is Metadate CD a controlled substance?Schedule II
- What is Methylphenidate used for?FDA label uses
- Is Methylphenidate a controlled substance?Schedule II
- Generic for Aptensio XRFDA Orange Book
- Generic for Jornay PMFDA Orange Book
- Generic for Ritalin LAFDA Orange Book
- Generic for DaytranaFDA Orange Book
- Generic for Quillivant XRFDA Orange Book
- Generic for MethylinFDA Orange Book
- Generic for QuilliChew ERFDA Orange Book
- Generic for ConcertaFDA Orange Book
- Generic for RelexxiiFDA Orange Book
- Generic for Ritalin-srFDA Orange Book
- Generic for Cotempla XR-ODTFDA Orange Book
- Central Nervous System Stimulants listFDA drug class