ampicillin

Generic: ampicillin

Labeler: steriscience specialties private limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ampicillin
Generic Name ampicillin
Labeler steriscience specialties private limited
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

ampicillin sodium 2 g/1

Manufacturer
Steriscience Specialties Private Limited

Identifiers & Regulatory

Product NDC 82449-512
Product ID 82449-512_fb85df45-6918-776e-e053-6294a90a2aaf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201025
Listing Expiration 2026-12-31
Marketing Start 2023-05-12

Pharmacologic Class

Classes
penicillin-class antibacterial [epc] penicillins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82449512
Hyphenated Format 82449-512

Supplemental Identifiers

RxCUI
1721473 1721474 1721475 1721476
UNII
JFN36L5S8K

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 (source: ndc)
Generic Name ampicillin (source: ndc)
Application Number ANDA201025 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 g/1
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (82449-512-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
source: ndc

Packages (1)

82449-512-10 10 VIAL in 1 CARTON (82449-512-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

Ingredients (1)

ampicillin sodium (2 g/1)

Linked Drug Pages (1)

Ampicillin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "fb85df45-6918-776e-e053-6294a90a2aaf", "openfda": {"unii": ["JFN36L5S8K"], "rxcui": ["1721473", "1721474", "1721475", "1721476"], "spl_set_id": ["fb85d59d-9951-5ff4-e053-6294a90a015e"], "manufacturer_name": ["Steriscience Specialties Private Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (82449-512-10)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL", "package_ndc": "82449-512-10", "marketing_start_date": "20230512"}], "brand_name": "Ampicillin", "product_id": "82449-512_fb85df45-6918-776e-e053-6294a90a2aaf", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]"], "product_ndc": "82449-512", "generic_name": "Ampicillin", "labeler_name": "Steriscience Specialties Private Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ampicillin", "active_ingredients": [{"name": "AMPICILLIN SODIUM", "strength": "2 g/1"}], "application_number": "ANDA201025", "marketing_category": "ANDA", "marketing_start_date": "20230512", "listing_expiration_date": "20261231"}