Hydrocodone Bitartrate and Homatropine Methylbromide
These highlights do not include all the information needed to use [HYDROCODONEBITARTRATE AND HOMATROPINE METHYLBROMIDE TABLETS] safely and effectively. See full prescribing information for[HYDROCODONE BITARTRATE AND HOMATROPINEMETHYLBROMIDE TABLETS] Initial U.S. Approval:[1943]
Approved
Approval ID
41ac90b3-f007-4eb2-9d41-ea626ced2017
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 30, 2024
Manufacturers
FDA
Lupin Pharmaceuticals,Inc.
DUNS: 089153071
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydrocodone Bitartrate and Homatropine Methylbromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43386-118
Application NumberANDA091528
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocodone Bitartrate and Homatropine Methylbromide
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 30, 2024
FDA Product Classification
INGREDIENTS (7)
HYDROCODONE BITARTRATEActive
Quantity: 5 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
HOMATROPINE METHYLBROMIDEActive
Quantity: 1.5 mg in 1 1
Code: 68JRS2HC1C
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT