HYDROMORPHONE HYDROCHLORIDE
Approved
Approval ID
471f8bb8-c23f-49f2-8685-2b2aa514e076
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 5, 2011
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
HYDROMORPHONE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-827
Application NumberANDA078273
Product Classification
M
Marketing Category
C73584
G
Generic Name
HYDROMORPHONE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMay 5, 2011
FDA Product Classification
INGREDIENTS (5)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROMORPHONE HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: L960UP2KRW
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT