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.
Dexmethylphenidate Hydrochloride
Product Details
NDC Product Code
63629-2305Application Number
ANDA207901Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 16, 2021FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
DexmethylphenidateActive
Code: 1678OK0E08Class: ACTIBQuantity: 2.5 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT