ampicillin

Generic: ampicillin sodium

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ampicillin
Generic Name ampicillin sodium
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ampicillin sodium 500 mg/1

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-016
Product ID 65219-016_38c6c088-e4ab-4859-b4d9-89e846cf9d5f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062719
Listing Expiration 2026-12-31
Marketing Start 2020-08-03

Pharmacologic Class

Classes
penicillin-class antibacterial [epc] penicillins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219016
Hyphenated Format 65219-016

Supplemental Identifiers

RxCUI
1721473 1721474 1721475 1721476
UNII
JFN36L5S8K

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ampicillin (source: ndc)
Generic Name ampicillin sodium (source: ndc)
Application Number ANDA062719 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (65219-016-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (65219-016-01)
source: ndc

Packages (1)

65219-016-10 10 VIAL in 1 CARTON (65219-016-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (65219-016-01)

Ingredients (1)

ampicillin sodium (500 mg/1)

Linked Drug Pages (1)

Ampicillin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "38c6c088-e4ab-4859-b4d9-89e846cf9d5f", "openfda": {"unii": ["JFN36L5S8K"], "rxcui": ["1721473", "1721474", "1721475", "1721476"], "spl_set_id": ["8dbb4c71-8543-08f1-e053-2995a90af88d"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (65219-016-10)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (65219-016-01)", "package_ndc": "65219-016-10", "marketing_start_date": "20200803"}], "brand_name": "Ampicillin", "product_id": "65219-016_38c6c088-e4ab-4859-b4d9-89e846cf9d5f", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]"], "product_ndc": "65219-016", "generic_name": "ampicillin sodium", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ampicillin", "active_ingredients": [{"name": "AMPICILLIN SODIUM", "strength": "500 mg/1"}], "application_number": "ANDA062719", "marketing_category": "ANDA", "marketing_start_date": "20200803", "listing_expiration_date": "20261231"}