ampicillin and sulbactam

Generic: ampicillin and sulbactam

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ampicillin and sulbactam
Generic Name ampicillin and sulbactam
Labeler sagent pharmaceuticals
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

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

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-144
Product ID 25021-144_6be243c8-0de8-4b13-972f-9300db172339
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065403
Listing Expiration 2026-12-31
Marketing Start 2010-08-12

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 25021144
Hyphenated Format 25021-144

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
  • 1 BOTTLE in 1 CARTON (25021-144-99) / 100 mL in 1 BOTTLE
source: ndc

Packages (1)

Ingredients (2)

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

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "6be243c8-0de8-4b13-972f-9300db172339", "openfda": {"unii": ["JFN36L5S8K", "DKQ4T82YE6"], "rxcui": ["240984"], "spl_set_id": ["35606b43-5914-423c-9bc7-fa3957eb2563"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (25021-144-99)  / 100 mL in 1 BOTTLE", "package_ndc": "25021-144-99", "marketing_start_date": "20100812"}], "brand_name": "ampicillin and sulbactam", "product_id": "25021-144_6be243c8-0de8-4b13-972f-9300db172339", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "25021-144", "generic_name": "ampicillin and sulbactam", "labeler_name": "Sagent Pharmaceuticals", "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": "20100812", "listing_expiration_date": "20261231"}