ampicillin and sulbactam (83634-110)

Drug Facts

Product Profile

Brand Name ampicillin and sulbactam

Generic Name ampicillin and sulbactam

Labeler avenacy, llc

Dosage Form INJECTION, POWDER, FOR SOLUTION

Routes

INTRAMUSCULAR INTRAVENOUS

Active Ingredients

ampicillin sodium 2 g/1, sulbactam sodium 1 g/1

Manufacturer

Avenacy, LLC

Identifiers & Regulatory

Product NDC 83634-110

Product ID 83634-110_defc86ea-aea6-4978-b547-2473933197ef

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA065222

Listing Expiration 2026-12-31

Marketing Start 2025-02-01

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 83634110

Hyphenated Format 83634-110

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 and sulbactam (source: ndc)

Generic Name ampicillin and sulbactam (source: ndc)

Application Number ANDA065222 (source: ndc)

Routes

INTRAMUSCULAR INTRAVENOUS

source: ndc

Resolved Composition

Strengths

2 g/1
1 g/1

source: ndc

Packaging

10 VIAL, SINGLE-DOSE in 1 CARTON (83634-110-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (83634-110-41)

source: ndc

Packages (1)

83634-110-20 10 VIAL, SINGLE-DOSE in 1 CARTON (83634-110-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (83634-110-41)

Ingredients (2)

ampicillin sodium (2 g/1) sulbactam sodium (1 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": "defc86ea-aea6-4978-b547-2473933197ef", "openfda": {"unii": ["JFN36L5S8K", "DKQ4T82YE6"], "rxcui": ["1659592", "1659598"], "spl_set_id": ["4446d4c8-056d-4bc3-8f58-21255b063398"], "manufacturer_name": ["Avenacy, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (83634-110-20)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (83634-110-41)", "package_ndc": "83634-110-20", "marketing_start_date": "20250425"}], "brand_name": "Ampicillin and Sulbactam", "product_id": "83634-110_defc86ea-aea6-4978-b547-2473933197ef", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "83634-110", "generic_name": "ampicillin and sulbactam", "labeler_name": "Avenacy, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ampicillin and Sulbactam", "active_ingredients": [{"name": "AMPICILLIN SODIUM", "strength": "2 g/1"}, {"name": "SULBACTAM SODIUM", "strength": "1 g/1"}], "application_number": "ANDA065222", "marketing_category": "ANDA", "marketing_start_date": "20250201", "listing_expiration_date": "20261231"}