amoxicillin

Generic: amoxicillin

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

Drug Facts

Product Profile

Brand Name amoxicillin
Generic Name amoxicillin
Labeler hikma pharmaceuticals usa inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

amoxicillin 875 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9285
Product ID 0143-9285_a4cd19b3-f938-4afe-9409-3bdea10deb63
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065255
Listing Expiration 2026-12-31
Marketing Start 2006-03-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439285
Hyphenated Format 0143-9285

Supplemental Identifiers

RxCUI
308194
UPC
0301439285205 0301439285014
UNII
804826J2HU

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 amoxicillin (source: ndc)
Generic Name amoxicillin (source: ndc)
Application Number ANDA065255 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 875 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE (0143-9285-01)
  • 20 TABLET, COATED in 1 BOTTLE (0143-9285-20)
source: ndc

Packages (2)

0143-9285-01 100 TABLET, COATED in 1 BOTTLE (0143-9285-01) 0143-9285-20 20 TABLET, COATED in 1 BOTTLE (0143-9285-20)

Ingredients (1)

amoxicillin (875 mg/1)

Linked Drug Pages (1)

Amoxicillin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a4cd19b3-f938-4afe-9409-3bdea10deb63", "openfda": {"upc": ["0301439285205", "0301439285014"], "unii": ["804826J2HU"], "rxcui": ["308194"], "spl_set_id": ["c8591c2a-92ef-4432-b19a-bb46063047ee"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (0143-9285-01)", "package_ndc": "0143-9285-01", "marketing_start_date": "20060329"}, {"sample": false, "description": "20 TABLET, COATED in 1 BOTTLE (0143-9285-20)", "package_ndc": "0143-9285-20", "marketing_start_date": "20060329"}], "brand_name": "Amoxicillin", "product_id": "0143-9285_a4cd19b3-f938-4afe-9409-3bdea10deb63", "dosage_form": "TABLET, COATED", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]"], "product_ndc": "0143-9285", "generic_name": "Amoxicillin", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amoxicillin", "active_ingredients": [{"name": "AMOXICILLIN", "strength": "875 mg/1"}], "application_number": "ANDA065255", "marketing_category": "ANDA", "marketing_start_date": "20060329", "listing_expiration_date": "20261231"}