Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
American Health Packaging
American Health Packaging
929561009
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydromorphone Hydrochloride
Product Details
NDC Product Code
60687-579Application Number
ANDA076855Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 11, 2023LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
HydromorphoneActive
Code: L960UP2KRWClass: ACTIBQuantity: 2 mg in 1 1
Hydromorphone Hydrochloride
Product Details
NDC Product Code
60687-590Application Number
ANDA076855Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 11, 2023LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
HydromorphoneActive
Code: L960UP2KRWClass: ACTIBQuantity: 4 mg in 1 1