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 POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

amoxicillin 250 mg/5mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9889
Product ID 0143-9889_c2fa2c99-c735-4834-a8a5-04a30da8a002
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065322
Listing Expiration 2026-12-31
Marketing Start 2006-06-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439889
Hyphenated Format 0143-9889

Supplemental Identifiers

RxCUI
239191 313797
UPC
0301439888017 0301439889014
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 ANDA065322 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/5mL
source: ndc
Packaging
  • 100 mL in 1 BOTTLE (0143-9889-01)
  • 150 mL in 1 BOTTLE (0143-9889-15)
  • 80 mL in 1 BOTTLE (0143-9889-80)
source: ndc

Packages (3)

0143-9889-01 100 mL in 1 BOTTLE (0143-9889-01) 0143-9889-15 150 mL in 1 BOTTLE (0143-9889-15) 0143-9889-80 80 mL in 1 BOTTLE (0143-9889-80)

Ingredients (1)

amoxicillin (250 mg/5mL)

Linked Drug Pages (1)

Amoxicillin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c2fa2c99-c735-4834-a8a5-04a30da8a002", "openfda": {"upc": ["0301439888017", "0301439889014"], "unii": ["804826J2HU"], "rxcui": ["239191", "313797"], "spl_set_id": ["077f4a65-3cfb-4cb1-99f2-e27ffc5939c0"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE (0143-9889-01)", "package_ndc": "0143-9889-01", "marketing_start_date": "20060619"}, {"sample": false, "description": "150 mL in 1 BOTTLE (0143-9889-15)", "package_ndc": "0143-9889-15", "marketing_start_date": "20060619"}, {"sample": false, "description": "80 mL in 1 BOTTLE (0143-9889-80)", "package_ndc": "0143-9889-80", "marketing_start_date": "20060619"}], "brand_name": "Amoxicillin", "product_id": "0143-9889_c2fa2c99-c735-4834-a8a5-04a30da8a002", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]"], "product_ndc": "0143-9889", "generic_name": "Amoxicillin", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amoxicillin", "active_ingredients": [{"name": "AMOXICILLIN", "strength": "250 mg/5mL"}], "application_number": "ANDA065322", "marketing_category": "ANDA", "marketing_start_date": "20060619", "listing_expiration_date": "20261231"}