ampicillin and sulbactam

Generic: ampicillin and sulbactam

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

Drug Facts

Product Profile

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

ampicillin sodium 1 g/1.5g, sulbactam sodium .5 g/1.5g

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6116
Product ID 0641-6116_c0a3fa06-81d0-410a-8f9b-2be2b03fdc3b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065406
Listing Expiration 2026-12-31
Marketing Start 2009-12-22

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 06416116
Hyphenated Format 0641-6116

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 and sulbactam (source: ndc)
Application Number ANDA065406 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 g/1.5g
  • .5 g/1.5g
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (0641-6116-10) / 1.5 g in 1 VIAL (0641-6116-01)
source: ndc

Packages (1)

0641-6116-10 10 VIAL in 1 CARTON (0641-6116-10) / 1.5 g in 1 VIAL (0641-6116-01)

Ingredients (2)

ampicillin sodium (1 g/1.5g) sulbactam sodium (.5 g/1.5g)

Linked Drug Pages (1)

Ampicillin and Sulbactam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "c0a3fa06-81d0-410a-8f9b-2be2b03fdc3b", "openfda": {"unii": ["JFN36L5S8K", "DKQ4T82YE6"], "rxcui": ["1659592", "1659598"], "spl_set_id": ["d3026cc0-95d8-44cf-be47-b5ebb8fd4568"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (0641-6116-10)  / 1.5 g in 1 VIAL (0641-6116-01)", "package_ndc": "0641-6116-10", "marketing_start_date": "20091222"}], "brand_name": "Ampicillin and Sulbactam", "product_id": "0641-6116_c0a3fa06-81d0-410a-8f9b-2be2b03fdc3b", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "0641-6116", "generic_name": "Ampicillin and Sulbactam", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ampicillin and Sulbactam", "active_ingredients": [{"name": "AMPICILLIN SODIUM", "strength": "1 g/1.5g"}, {"name": "SULBACTAM SODIUM", "strength": ".5 g/1.5g"}], "application_number": "ANDA065406", "marketing_category": "ANDA", "marketing_start_date": "20091222", "listing_expiration_date": "20261231"}