Famotidine
Famotidine Injection, USP
Approved
Approval ID
1fdf16e5-145d-4c19-a318-fc6c10794b50
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2024
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 946499746
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Famotidine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0641-6022
Application NumberANDA075486
Product Classification
M
Marketing Category
C73584
G
Generic Name
Famotidine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 18, 2024
FDA Product Classification
INGREDIENTS (4)
FAMOTIDINEActive
Quantity: 10 mg in 1 mL
Code: 5QZO15J2Z8
Classification: ACTIB
ASPARTIC ACIDInactive
Quantity: 4 mg in 1 mL
Code: 30KYC7MIAI
Classification: IACT
MANNITOLInactive
Quantity: 20 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Famotidine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0641-6021
Application NumberANDA075488
Product Classification
M
Marketing Category
C73584
G
Generic Name
Famotidine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 18, 2024
FDA Product Classification
INGREDIENTS (5)
FAMOTIDINEActive
Quantity: 10 mg in 1 mL
Code: 5QZO15J2Z8
Classification: ACTIB
ASPARTIC ACIDInactive
Quantity: 4 mg in 1 mL
Code: 30KYC7MIAI
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MANNITOLInactive
Quantity: 20 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 9 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
Famotidine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0641-6023
Application NumberANDA075488
Product Classification
M
Marketing Category
C73584
G
Generic Name
Famotidine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 18, 2024
FDA Product Classification
INGREDIENTS (5)
FAMOTIDINEActive
Quantity: 10 mg in 1 mL
Code: 5QZO15J2Z8
Classification: ACTIB
ASPARTIC ACIDInactive
Quantity: 4 mg in 1 mL
Code: 30KYC7MIAI
Classification: IACT
MANNITOLInactive
Quantity: 20 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 9 mg in 1 mL
Code: LKG8494WBH
Classification: IACT