Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Bryant Ranch Prepack
171714327
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bryant Ranch Prepack
Bryant Ranch Prepack
Bryant Ranch Prepack
171714327
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Methylphenidate Hydrochloride
Product Details
NDC Product Code
63629-2461Application Number
ANDA205327Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 24, 2021CELLULOSE ACETATEInactive
Code: 3J2P07GVB6Class: IACT
MethylphenidateActive
Code: 4B3SC438HIClass: ACTIBQuantity: 36 mg in 1 1
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SUCCINIC ACIDInactive
Code: AB6MNQ6J6LClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NNClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POLYETHYLENE OXIDE 200000Inactive
Code: 11628IH70OClass: IACT
POLYETHYLENE OXIDE 5000000Inactive
Code: 3IG9032SAHClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT