Hydrocodone Bitartrate and Homatropine Methylbromide
These highlights do not include all the information needed to use Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution safely and effectively. See full prescribing information for Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution.Initial U.S. Approval: 1943
Approved
Approval ID
363701bc-1d0b-4cd0-a3a6-e0c3c849013a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 7, 2021
Manufacturers
FDA
ATLANTIC BIOLOGICALS CORP.
DUNS: 047437707
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 Code17856-0455
Application NumberANDA088008
Product Classification
M
Marketing Category
C73584
G
Generic Name
hydrocodone bitartrate and homatropine methylbromide
Product Specifications
Route of AdministrationORAL
Effective DateApril 7, 2021
FDA Product Classification
INGREDIENTS (13)
HYDROCODONE BITARTRATEActive
Quantity: 5 mg in 5 mL
Code: NO70W886KK
Classification: ACTIB
HOMATROPINE METHYLBROMIDEActive
Quantity: 1.5 mg in 5 mL
Code: 68JRS2HC1C
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
CARAMELInactive
Code: T9D99G2B1R
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT