amoxicillin

Generic: amoxicillin

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amoxicillin
Generic Name amoxicillin
Labeler direct_rx
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

amoxicillin 875 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-463
Product ID 72189-463_2c4de9c8-898d-f59d-e063-6294a90afdc1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065228
Listing Expiration 2026-12-31
Marketing Start 2023-04-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189463
Hyphenated Format 72189-463

Supplemental Identifiers

RxCUI
308194
UNII
804826J2HU

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 ANDA065228 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 875 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED in 1 BOTTLE (72189-463-20)
source: ndc

Packages (1)

72189-463-20 20 TABLET, FILM COATED in 1 BOTTLE (72189-463-20)

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": "2c4de9c8-898d-f59d-e063-6294a90afdc1", "openfda": {"unii": ["804826J2HU"], "rxcui": ["308194"], "spl_set_id": ["f98c49a3-e6bb-7fc7-e053-6394a90a9062"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (72189-463-20)", "package_ndc": "72189-463-20", "marketing_start_date": "20230417"}], "brand_name": "Amoxicillin", "product_id": "72189-463_2c4de9c8-898d-f59d-e063-6294a90afdc1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]"], "product_ndc": "72189-463", "generic_name": "Amoxicillin", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amoxicillin", "active_ingredients": [{"name": "AMOXICILLIN", "strength": "875 mg/1"}], "application_number": "ANDA065228", "marketing_category": "ANDA", "marketing_start_date": "20230417", "listing_expiration_date": "20261231"}