amoxicillin

Generic: amoxicillin

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amoxicillin
Generic Name amoxicillin
Labeler asclemed usa, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

amoxicillin 500 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-545
Product ID 76420-545_f7278cd0-99b5-9e8e-e053-6294a90a66e7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA061926
Listing Expiration 2026-12-31
Marketing Start 1990-09-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420545
Hyphenated Format 76420-545

Supplemental Identifiers

RxCUI
308191
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 ANDA061926 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 50 CAPSULE in 1 BOTTLE (76420-545-50)
source: ndc

Packages (1)

76420-545-50 50 CAPSULE in 1 BOTTLE (76420-545-50)

Ingredients (1)

amoxicillin (500 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": "f7278cd0-99b5-9e8e-e053-6294a90a66e7", "openfda": {"unii": ["804826J2HU"], "rxcui": ["308191"], "spl_set_id": ["be1d1a44-7ef3-445d-9970-494921de4c9d"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "50 CAPSULE in 1 BOTTLE (76420-545-50)", "package_ndc": "76420-545-50", "marketing_start_date": "20230318"}], "brand_name": "Amoxicillin", "product_id": "76420-545_f7278cd0-99b5-9e8e-e053-6294a90a66e7", "dosage_form": "CAPSULE", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]"], "product_ndc": "76420-545", "generic_name": "Amoxicillin", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amoxicillin", "active_ingredients": [{"name": "AMOXICILLIN", "strength": "500 mg/1"}], "application_number": "ANDA061926", "marketing_category": "ANDA", "marketing_start_date": "19900930", "listing_expiration_date": "20261231"}