ampicillin and sulbactam

Generic: ampicillin sodium and sulbactam sodium

Labeler: meitheal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ampicillin and sulbactam
Generic Name ampicillin sodium and sulbactam sodium
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

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

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-032
Product ID 71288-032_f8b66438-eeee-4177-9a49-8fb725dc6672
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065222
Listing Expiration 2026-12-31
Marketing Start 2005-11-29

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 71288032
Hyphenated Format 71288-032

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 sodium and sulbactam sodium (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 (71288-032-21) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-032-20)
source: ndc

Packages (1)

Ingredients (2)

ampicillin sodium (2 g/1) sulbactam sodium (1 g/1)

Linked Drug Pages (2)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "f8b66438-eeee-4177-9a49-8fb725dc6672", "openfda": {"unii": ["JFN36L5S8K", "DKQ4T82YE6"], "rxcui": ["1659592", "1659598"], "spl_set_id": ["e6cf14a8-3ed9-4a7a-ba69-be0b794cbdc4"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (71288-032-21)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-032-20)", "package_ndc": "71288-032-21", "marketing_start_date": "20051129"}], "brand_name": "Ampicillin and Sulbactam", "product_id": "71288-032_f8b66438-eeee-4177-9a49-8fb725dc6672", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "71288-032", "generic_name": "Ampicillin sodium and Sulbactam sodium", "labeler_name": "Meitheal Pharmaceuticals Inc.", "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": "20051129", "listing_expiration_date": "20261231"}