Hydrocodone Bitartrate and Ibuprofen
HYDROCODONE/IBU 7.5/200mg
Approved
Approval ID
8909cfeb-e928-82b5-e053-2995a90a71b8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 14, 2021
Manufacturers
FDA
RedPharm Drug, Inc.
DUNS: 828374897
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydrocodone Bitartrate and Ibuprofen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67296-1655
Application NumberANDA204575
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocodone Bitartrate and Ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 14, 2021
FDA Product Classification
INGREDIENTS (9)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROCODONE BITARTRATEActive
Quantity: 7.5 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
IBUPROFENActive
Quantity: 200 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB