Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
EPM Packaging, Inc.
RedPharm Drug, Inc.
079124340
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydrocodone Bitartrate and Acetaminophen
Product Details
NDC Product Code
67296-1425Application Number
ANDA211487Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 25, 2021MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
HydrocodoneActive
Code: NO70W886KKClass: ACTIBQuantity: 10 mg in 1 1
AcetaminophenActive
Code: 362O9ITL9DClass: ACTIBQuantity: 325 mg in 1 1
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT