ampicillin sodium and sulbactam sodium

Generic: ampicillin sodium, sulbactam sodium

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

Drug Facts

Product Profile

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

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

Manufacturer
Armas Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 72485-417
Product ID 72485-417_44a1fdb7-5659-23bc-e063-6294a90a1ccd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201024
Listing Expiration 2026-12-31
Marketing Start 2023-04-25

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 72485417
Hyphenated Format 72485-417

Supplemental Identifiers

RxCUI
1659592 1659598
UPC
0372485416011 0372485417018
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 sodium and sulbactam sodium (source: ndc)
Generic Name ampicillin sodium, sulbactam sodium (source: ndc)
Application Number ANDA201024 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 g/1
  • 1 g/1
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (72485-417-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-417-01)
source: ndc

Packages (1)

72485-417-10 10 VIAL in 1 CARTON (72485-417-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-417-01)

Ingredients (2)

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

Linked Drug Pages (1)

Ampicillin Sodium and Sulbactam Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "44a1fdb7-5659-23bc-e063-6294a90a1ccd", "openfda": {"upc": ["0372485416011", "0372485417018"], "unii": ["JFN36L5S8K", "DKQ4T82YE6"], "rxcui": ["1659592", "1659598"], "spl_set_id": ["ac6f8158-9d7e-4b99-af3c-0407c5287b57"], "manufacturer_name": ["Armas Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (72485-417-10)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-417-01)", "package_ndc": "72485-417-10", "marketing_start_date": "20230425"}], "brand_name": "Ampicillin Sodium and Sulbactam Sodium", "product_id": "72485-417_44a1fdb7-5659-23bc-e063-6294a90a1ccd", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "72485-417", "generic_name": "ampicillin sodium, sulbactam sodium", "labeler_name": "Armas Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ampicillin Sodium and Sulbactam Sodium", "active_ingredients": [{"name": "AMPICILLIN SODIUM", "strength": "2 g/1"}, {"name": "SULBACTAM SODIUM", "strength": "1 g/1"}], "application_number": "ANDA201024", "marketing_category": "ANDA", "marketing_start_date": "20230425", "listing_expiration_date": "20261231"}