Hydrocodone Bitartrate and Homatropine Methylbromide
These highlights do not include all the information needed to use HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLETS safely and effectively. See full prescribing information for HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLETS HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLETS for oral administration, CII Initial U.S. Approval: 1943
Approved
Approval ID
b203c87c-1108-4eaa-8a57-87be776d8a70
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 12, 2023
Manufacturers
FDA
Novel Laboratories, Inc.
DUNS: 793518643
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 Code40032-118
Application NumberANDA091528
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocodone Bitartrate and Homatropine Methylbromide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 12, 2023
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