Carbinoxamine Maleate
Approved
Approval ID
1edca669-8879-408a-b09c-259e363dd95c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 23, 2022
Manufacturers
FDA
Breckenridge Pharmaceutical, Inc.
DUNS: 150554335
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
carbinoxamine maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51991-334
Application NumberANDA040458
Product Classification
M
Marketing Category
C73584
G
Generic Name
carbinoxamine maleate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 23, 2022
FDA Product Classification
INGREDIENTS (9)
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
CARBINOXAMINE MALEATEActive
Quantity: 4 mg in 5 mL
Code: 02O55696WH
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
carbinoxamine maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51991-333
Application NumberANDA040442
Product Classification
M
Marketing Category
C73584
G
Generic Name
carbinoxamine maleate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 23, 2022
FDA Product Classification
INGREDIENTS (5)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CARBINOXAMINE MALEATEActive
Quantity: 4 mg in 1 1
Code: 02O55696WH
Classification: ACTIB