Famotidine
Famotidine Injection, USP
Approved
Approval ID
e3b13e23-122b-4bd4-95cf-b5a14b7afc05
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 19, 2020
Manufacturers
FDA
Mylan Institutional LLC
DUNS: 790384502
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 Code67457-448
Application NumberANDA078641
Product Classification
M
Marketing Category
C73584
G
Generic Name
Famotidine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 5, 2018
FDA Product Classification
INGREDIENTS (5)
FAMOTIDINEActive
Quantity: 10 mg in 1 mL
Code: 5QZO15J2Z8
Classification: ACTIB
ASPARTIC ACIDInactive
Code: 30KYC7MIAI
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Famotidine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67457-433
Application NumberANDA078642
Product Classification
M
Marketing Category
C73584
G
Generic Name
Famotidine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 5, 2018
FDA Product Classification
INGREDIENTS (4)
FAMOTIDINEActive
Quantity: 10 mg in 1 mL
Code: 5QZO15J2Z8
Classification: ACTIB
ASPARTIC ACIDInactive
Code: 30KYC7MIAI
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Famotidine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67457-457
Application NumberANDA078641
Product Classification
M
Marketing Category
C73584
G
Generic Name
Famotidine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 5, 2018
FDA Product Classification
INGREDIENTS (5)
FAMOTIDINEActive
Quantity: 10 mg in 1 mL
Code: 5QZO15J2Z8
Classification: ACTIB
ASPARTIC ACIDInactive
Code: 30KYC7MIAI
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT