ampicillin and sulbactam (83634-108)

Drug Facts

Product Profile

Brand Name ampicillin and sulbactam

Generic Name ampicillin and sulbactam

Labeler avenacy, llc

Dosage Form INJECTION, POWDER, FOR SOLUTION

Routes

INTRAVENOUS

Active Ingredients

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

Manufacturer

Avenacy, LLC

Identifiers & Regulatory

Product NDC 83634-108

Product ID 83634-108_2facc8c4-46fb-4562-a621-a856ec473567

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA065314

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 83634108

Hyphenated Format 83634-108

Supplemental Identifiers

RxCUI

240984

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 ANDA065314 (source: ndc)

Routes

INTRAVENOUS

source: ndc

Resolved Composition

Strengths

10 g/1
5 g/1

source: ndc

Packaging

1 BOTTLE in 1 CARTON (83634-108-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE

source: ndc

Packages (1)

83634-108-99 1 BOTTLE in 1 CARTON (83634-108-99) / 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": ["INTRAVENOUS"], "spl_id": "2facc8c4-46fb-4562-a621-a856ec473567", "openfda": {"unii": ["JFN36L5S8K", "DKQ4T82YE6"], "rxcui": ["240984"], "spl_set_id": ["577dd6f0-d56a-4c82-9f72-274c3a4a0f01"], "manufacturer_name": ["Avenacy, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (83634-108-99)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE", "package_ndc": "83634-108-99", "marketing_start_date": "20250424"}], "brand_name": "Ampicillin and Sulbactam", "product_id": "83634-108_2facc8c4-46fb-4562-a621-a856ec473567", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "83634-108", "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": "10 g/1"}, {"name": "SULBACTAM SODIUM", "strength": "5 g/1"}], "application_number": "ANDA065314", "marketing_category": "ANDA", "marketing_start_date": "20250201", "listing_expiration_date": "20261231"}