ampicillin sodium and sulbactam sodium (83270-304)

Drug Facts

Product Profile

Brand Name ampicillin sodium and sulbactam sodium

Generic Name ampicillin sodium and sulbactam sodium

Labeler onesource specialty pharma limited

Dosage Form INJECTION, POWDER, FOR SOLUTION

Routes

INTRAMUSCULAR INTRAVENOUS

Active Ingredients

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

Manufacturer

ONESOURCE SPECIALTY PHARMA LIMITED

Identifiers & Regulatory

Product NDC 83270-304

Product ID 83270-304_44180e69-5422-2235-e063-6394a90aae5d

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA201024

Listing Expiration 2026-12-31

Marketing Start 2023-04-14

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 83270304

Hyphenated Format 83270-304

Supplemental Identifiers

RxCUI

1659592 1659598

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 sodium and sulbactam sodium (source: ndc)

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

Application Number ANDA201024 (source: ndc)

Routes

INTRAMUSCULAR INTRAVENOUS

source: ndc

Resolved Composition

Strengths

1 g/1
.5 g/1

source: ndc

Packaging

10 VIAL in 1 CARTON (83270-304-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

source: ndc

Packages (1)

83270-304-10 10 VIAL in 1 CARTON (83270-304-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

Ingredients (2)

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

Linked Drug Pages (1)

ampicillin sodium and sulbactam sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "44180e69-5422-2235-e063-6394a90aae5d", "openfda": {"unii": ["JFN36L5S8K", "DKQ4T82YE6"], "rxcui": ["1659592", "1659598"], "spl_set_id": ["44181723-ef09-301b-e063-6394a90a2cad"], "manufacturer_name": ["ONESOURCE SPECIALTY PHARMA LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (83270-304-10)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL", "package_ndc": "83270-304-10", "marketing_start_date": "20230414"}], "brand_name": "ampicillin sodium and sulbactam sodium", "product_id": "83270-304_44180e69-5422-2235-e063-6394a90aae5d", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "83270-304", "generic_name": "ampicillin sodium and sulbactam sodium", "labeler_name": "ONESOURCE SPECIALTY PHARMA LIMITED", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ampicillin sodium and sulbactam sodium", "active_ingredients": [{"name": "AMPICILLIN SODIUM", "strength": "1 g/1"}, {"name": "SULBACTAM SODIUM", "strength": ".5 g/1"}], "application_number": "ANDA201024", "marketing_category": "ANDA", "marketing_start_date": "20230414", "listing_expiration_date": "20261231"}