ampicillin

Generic: ampicillin sodium

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ampicillin
Generic Name ampicillin sodium
Labeler sandoz inc
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ampicillin sodium 125 mg/1

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-3400
Product ID 0781-3400_2cc1b620-59dd-4d45-8edf-af20bdd82ee5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA061395
Listing Expiration 2026-12-31
Marketing Start 1971-03-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07813400
Hyphenated Format 0781-3400

Supplemental Identifiers

RxCUI
308207 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 sodium (source: ndc)
Application Number ANDA061395 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 125 mg/1
source: ndc
Packaging
  • HOW SUPPLIED Ampicillin for injection, USP for intramuscular or intravenous injection. Ampicillin sodium equivalent to 125 mg, 250 mg, 500 mg, 1 gram, or 2 grams ampicillin per vial. NDC 0781-3400-95 125 mg vial packaged in 10s NDC 0781-3402-95 250 mg vial packaged in 10s NDC 0781-3407-95 500 mg vial packaged in 10s NDC 0781-3404-95 1 gram vial packaged in 10s NDC 0781-3408-95 2 gram vial packaged in 10s Also available as: NDC 0781-3409-95 10 gram Pharmacy Bulk Package packaged in 10s Storage Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect the constituted solution from freezing. Clinitest is a registered trademark of Miles, Inc. Clinistix is a registered trademark of Bayer Corporation. Tes-Tape is a registered trademark of Eli Lilly Company. Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540 Revised: 02/2025
  • 125 mg Label NDC 0781-3400-95 Ampicillin for Injection, USP 125 mg per vial Rx Only Case Qty.: 10 Vials Store the dry powder at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. SANDOZ – A Novartis Division 125mg-case-label
  • 250 mg Label NDC 0781-3402-95 Ampicillin for Injection, USP 250 mg per vial Rx Only Case Quantity: 10 Vials Store the dry powder at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. SANDOZ 250mg-case-label
  • 500 mg Label NDC 0781-3407-95 Ampicillin for Injection, USP 500 mg per vial Rx Only Case Quantity: 10 Vials Store the dry powder at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. SANDOZ 500mg-case-label
  • 1 gram Label NDC 0781-3404-95 Ampicillin for Injection, USP 1 gram per vial Rx Only For Intramuscular or Intravenous Use 10 x 1 gram Single-Dose Vials SANDOZ 1gm-carton-label
  • 2 gram Label NDC 0781-3408-95 Ampicillin for Injection, USP 2 grams per vial Rx Only For Intramuscular or Intravenous Use 10 x 2 grams Single-Dose Vials SANDOZ 2gm-carton-label
source: label

Packages (0)

No package records.

Ingredients (1)

ampicillin sodium (125 mg/1)

Linked Drug Pages (1)

Ampicillin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "2cc1b620-59dd-4d45-8edf-af20bdd82ee5", "openfda": {"unii": ["JFN36L5S8K"], "rxcui": ["308207", "1721473", "1721474", "1721475", "1721476"], "spl_set_id": ["64a04e8c-8f78-46b3-8f45-56ef225a4f74"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Ampicillin", "product_id": "0781-3400_2cc1b620-59dd-4d45-8edf-af20bdd82ee5", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]"], "product_ndc": "0781-3400", "generic_name": "Ampicillin sodium", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ampicillin", "active_ingredients": [{"name": "AMPICILLIN SODIUM", "strength": "125 mg/1"}], "application_number": "ANDA061395", "marketing_category": "ANDA", "marketing_start_date": "19710303", "listing_expiration_date": "20261231"}