ampicillin and sulbactam (0641-6118)

Drug Facts

Product Profile

Brand Name ampicillin and sulbactam

Generic Name ampicillin and sulbactam

Labeler hikma pharmaceuticals usa inc.

Dosage Form INJECTION, POWDER, FOR SOLUTION

Routes

INTRAVENOUS

Active Ingredients

ampicillin sodium 100 mg/mL, sulbactam sodium 50 mg/mL

Manufacturer

Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6118

Product ID 0641-6118_43dd9102-1a8e-47c9-a65c-fc50ab4bbf5a

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA065403

Listing Expiration 2026-12-31

Marketing Start 2009-12-03

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 06416118

Hyphenated Format 0641-6118

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 ANDA065403 (source: ndc)

Routes

INTRAVENOUS

source: ndc

Resolved Composition

Strengths

100 mg/mL
50 mg/mL

source: ndc

Packaging

100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6118-01)

source: ndc

Packages (1)

0641-6118-01 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6118-01)

Ingredients (2)

ampicillin sodium (100 mg/mL) sulbactam sodium (50 mg/mL)

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": "43dd9102-1a8e-47c9-a65c-fc50ab4bbf5a", "openfda": {"unii": ["JFN36L5S8K", "DKQ4T82YE6"], "rxcui": ["240984"], "spl_set_id": ["a65a70bf-4283-4bc0-b576-00c9ab29bd64"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6118-01)", "package_ndc": "0641-6118-01", "marketing_start_date": "20091203"}], "brand_name": "Ampicillin and Sulbactam", "product_id": "0641-6118_43dd9102-1a8e-47c9-a65c-fc50ab4bbf5a", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "0641-6118", "generic_name": "Ampicillin and Sulbactam", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ampicillin and Sulbactam", "active_ingredients": [{"name": "AMPICILLIN SODIUM", "strength": "100 mg/mL"}, {"name": "SULBACTAM SODIUM", "strength": "50 mg/mL"}], "application_number": "ANDA065403", "marketing_category": "ANDA", "marketing_start_date": "20091203", "listing_expiration_date": "20261231"}