MedPath

Ampicillin

Ampicillin for Injection, USP

Approved
Approval ID

8dbb4c71-8543-08f1-e053-2995a90af88d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 21, 2022

Manufacturers
FDA

Fresenius Kabi USA, LLC

DUNS: 013547657

Products 4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ampicillin sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code65219-014
Application NumberANDA062719
Product Classification
M
Marketing Category
C73584
G
Generic Name
ampicillin sodium
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJanuary 24, 2020
FDA Product Classification

INGREDIENTS (1)

AMPICILLIN SODIUMActive
Quantity: 250 mg in 1 1
Code: JFN36L5S8K
Classification: ACTIM

ampicillin sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code65219-016
Application NumberANDA062719
Product Classification
M
Marketing Category
C73584
G
Generic Name
ampicillin sodium
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJanuary 24, 2020
FDA Product Classification

INGREDIENTS (1)

AMPICILLIN SODIUMActive
Quantity: 500 mg in 1 1
Code: JFN36L5S8K
Classification: ACTIM

ampicillin sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code65219-020
Application NumberANDA062797
Product Classification
M
Marketing Category
C73584
G
Generic Name
ampicillin sodium
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJanuary 24, 2020
FDA Product Classification

INGREDIENTS (1)

AMPICILLIN SODIUMActive
Quantity: 2 g in 1 1
Code: JFN36L5S8K
Classification: ACTIM

ampicillin sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code65219-018
Application NumberANDA062719
Product Classification
M
Marketing Category
C73584
G
Generic Name
ampicillin sodium
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJanuary 24, 2020
FDA Product Classification

INGREDIENTS (1)

AMPICILLIN SODIUMActive
Quantity: 1 g in 1 1
Code: JFN36L5S8K
Classification: ACTIM

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