unasyn

Generic: ampicillin sodium and sulbactam sodium

Labeler: roerig
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name unasyn
Generic Name ampicillin sodium and sulbactam sodium
Labeler roerig
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

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

Manufacturer
Roerig

Identifiers & Regulatory

Product NDC 0049-0014
Product ID 0049-0014_6b0299f2-a683-4c8f-bf62-b79d5f652b41
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050608
Listing Expiration 2026-12-31
Marketing Start 1991-11-22

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 00490014
Hyphenated Format 0049-0014

Supplemental Identifiers

RxCUI
1659592 1659595 1659598 1659600
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 unasyn (source: ndc)
Generic Name ampicillin sodium and sulbactam sodium (source: ndc)
Application Number NDA050608 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 g/1
  • 1 g/1
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (0049-0014-83) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0049-0014-81)
source: ndc

Packages (1)

0049-0014-83 10 VIAL in 1 CARTON (0049-0014-83) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0049-0014-81)

Ingredients (2)

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

Linked Drug Pages (1)

UNASYN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "6b0299f2-a683-4c8f-bf62-b79d5f652b41", "openfda": {"unii": ["JFN36L5S8K", "DKQ4T82YE6"], "rxcui": ["1659592", "1659595", "1659598", "1659600"], "spl_set_id": ["155c7ec0-5862-404f-b1d0-f278f8a8bbda"], "manufacturer_name": ["Roerig"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (0049-0014-83)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0049-0014-81)", "package_ndc": "0049-0014-83", "marketing_start_date": "19911122"}], "brand_name": "UNASYN", "product_id": "0049-0014_6b0299f2-a683-4c8f-bf62-b79d5f652b41", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "0049-0014", "generic_name": "ampicillin sodium and sulbactam sodium", "labeler_name": "Roerig", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "UNASYN", "active_ingredients": [{"name": "AMPICILLIN SODIUM", "strength": "2 g/1"}, {"name": "SULBACTAM SODIUM", "strength": "1 g/1"}], "application_number": "NDA050608", "marketing_category": "NDA", "marketing_start_date": "19911122", "listing_expiration_date": "20261231"}