Orange Book product · Brand (NDA)
RITALIN
METHYLPHENIDATE HYDROCHLORIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
METHYLPHENIDATE HYDROCHLORIDE
Strength
5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 010187
Product number
003
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2019ADHANSIA XRBrand (NDA)
NDA 212038 · KNOA PHARMA
- 2018JORNAY PMBrand (NDA)
NDA 209311 · IRONSHORE PHARMS
- 2015QUILLICHEW ERBrand (NDA)
NDA 207960 · NEXTWAVE PHARMS
- 2015APTENSIO XRBrand (NDA)
NDA 205831 · RHODES PHARMS
- 2012QUILLIVANT XRBrand (NDA)
NDA 202100 · NEXTWAVE
- 2004RITALIN LABrand (NDA)
NDA 021284 · SANDOZ
- 2003METADATE CDBrand (NDA)
NDA 021259 · AYTU BIOPHARMA
- 2003METHYLINBrand (NDA)
NDA 021475 · SPECGX LLC
- 2002METHYLINBrand (NDA)
NDA 021419 · SPECGX LLC
- 2000CONCERTABrand (NDA)
NDA 021121 · JANSSEN PHARMS
- 2023METHYLPHENIDATE HYDROCHLORIDEGeneric (ANDA)
ANDA 214447 · ALKEM LABS LTD
- 2021METHYLPHENIDATE HYDROCHLORIDEGeneric (ANDA)
ANDA 207417 · ASCENT PHARMS INC
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
