ampicillin and sulbactam

Generic: ampicillin sodium and sulbactam sodium

Labeler: northstar rx, llc
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 northstar rx, llc
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ampicillin sodium 1 g/1, sulbactam sodium .5 g/1

Manufacturer
NorthStar Rx, LLC

Identifiers & Regulatory

Product NDC 72603-220
Product ID 72603-220_c9fe0e6e-db1d-49ec-a16b-aa1de5ae7d5a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065222
Listing Expiration 2026-12-31
Marketing Start 2024-03-01

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 72603220
Hyphenated Format 72603-220

Supplemental Identifiers

RxCUI
1659592 1659598
UPC
0372603335019 0372603220018
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
  • 1 g/1
  • .5 g/1
source: ndc
Packaging
  • 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (72603-220-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

Ingredients (2)

ampicillin sodium (1 g/1) sulbactam sodium (.5 g/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "c9fe0e6e-db1d-49ec-a16b-aa1de5ae7d5a", "openfda": {"upc": ["0372603335019", "0372603220018"], "unii": ["JFN36L5S8K", "DKQ4T82YE6"], "rxcui": ["1659592", "1659598"], "spl_set_id": ["1e5004f1-e79e-4e0b-9f3f-25f6bbc15255"], "manufacturer_name": ["NorthStar Rx, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01)", "package_ndc": "72603-220-01", "marketing_start_date": "20240301"}, {"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (72603-220-10)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE", "package_ndc": "72603-220-10", "marketing_start_date": "20240301"}], "brand_name": "Ampicillin and Sulbactam", "product_id": "72603-220_c9fe0e6e-db1d-49ec-a16b-aa1de5ae7d5a", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "72603-220", "generic_name": "Ampicillin sodium and Sulbactam sodium", "labeler_name": "NorthStar Rx, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ampicillin and Sulbactam", "active_ingredients": [{"name": "AMPICILLIN SODIUM", "strength": "1 g/1"}, {"name": "SULBACTAM SODIUM", "strength": ".5 g/1"}], "application_number": "ANDA065222", "marketing_category": "ANDA", "marketing_start_date": "20240301", "listing_expiration_date": "20261231"}