Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
ATLANTIC BIOLOGICALS CORP.
ATLANTIC BIOLOGICALS CORP.
047437707
Products1
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
NDC Product Code
17856-0455Application Number
ANDA088008Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
April 7, 2021HydrocodoneActive
Code: NO70W886KKClass: ACTIBQuantity: 5 mg in 5 mL
Code: 68JRS2HC1CClass: ACTIBQuantity: 1.5 mg in 5 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0LClass: IACT
CARAMELInactive
Code: T9D99G2B1RClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT