ampicillin and sulbactam (72603-444)

Drug Facts

Product Profile

Brand Name ampicillin and sulbactam

Generic Name ampicillin sodium and sulbactam sodium

Labeler northstar rx, llc

Dosage Form INJECTION, POWDER, FOR SOLUTION

Routes

INTRAMUSCULAR INTRAVENOUS

Active Ingredients

ampicillin sodium 10 g/1, sulbactam sodium 5 g/1

Manufacturer

NorthStar Rx, LLC

Identifiers & Regulatory

Product NDC 72603-444

Product ID 72603-444_e02cc3e5-4a65-4312-b2b3-ea77601525e7

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA065314

Listing Expiration 2026-12-31

Marketing Start 2024-03-01

Pharmacologic Class

Classes

penicillin-class antibacterial [epc] penicillins [cs] beta lactamase inhibitor [epc] beta lactamase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72603444

Hyphenated Format 72603-444

Supplemental Identifiers

RxCUI

240984

UPC

0372603444018

UNII

JFN36L5S8K DKQ4T82YE6

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 and sulbactam (source: ndc)

Generic Name ampicillin sodium and sulbactam sodium (source: ndc)

Application Number ANDA065314 (source: ndc)

Routes

INTRAMUSCULAR INTRAVENOUS

source: ndc

Resolved Composition

Strengths

10 g/1
5 g/1

source: ndc

Packaging

10 BOTTLE in 1 CARTON (72603-444-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE

source: ndc

Packages (1)

72603-444-01 10 BOTTLE in 1 CARTON (72603-444-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE

Ingredients (2)

ampicillin sodium (10 g/1) sulbactam sodium (5 g/1)

Linked Drug Pages (1)

Ampicillin and Sulbactam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "e02cc3e5-4a65-4312-b2b3-ea77601525e7", "openfda": {"upc": ["0372603444018"], "unii": ["JFN36L5S8K", "DKQ4T82YE6"], "rxcui": ["240984"], "spl_set_id": ["5e8d35cb-e93d-42ad-a02c-0dbf04910f61"], "manufacturer_name": ["NorthStar Rx, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BOTTLE in 1 CARTON (72603-444-01)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE", "package_ndc": "72603-444-01", "marketing_start_date": "20240301"}], "brand_name": "Ampicillin and Sulbactam", "product_id": "72603-444_e02cc3e5-4a65-4312-b2b3-ea77601525e7", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "72603-444", "generic_name": "Ampicillin sodium and Sulbactam sodium", "labeler_name": "NorthStar Rx, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ampicillin and Sulbactam", "active_ingredients": [{"name": "AMPICILLIN SODIUM", "strength": "10 g/1"}, {"name": "SULBACTAM SODIUM", "strength": "5 g/1"}], "application_number": "ANDA065314", "marketing_category": "ANDA", "marketing_start_date": "20240301", "listing_expiration_date": "20261231"}