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 POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

amoxicillin 400 mg/5mL

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-819
Product ID 76420-819_1bc435f9-12b8-ccff-e063-6294a90a951a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065378
Listing Expiration 2026-12-31
Marketing Start 2007-03-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420819
Hyphenated Format 76420-819

Supplemental Identifiers

RxCUI
308189
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 ANDA065378 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/5mL
source: ndc
Packaging
  • 100 mL in 1 BOTTLE (76420-819-01)
  • 50 mL in 1 BOTTLE (76420-819-50)
  • 75 mL in 1 BOTTLE (76420-819-75)
source: ndc

Packages (3)

76420-819-01 100 mL in 1 BOTTLE (76420-819-01) 76420-819-50 50 mL in 1 BOTTLE (76420-819-50) 76420-819-75 75 mL in 1 BOTTLE (76420-819-75)

Ingredients (1)

amoxicillin (400 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": "1bc435f9-12b8-ccff-e063-6294a90a951a", "openfda": {"unii": ["804826J2HU"], "rxcui": ["308189"], "spl_set_id": ["830bb8fb-3743-463a-9317-3f83e3e105ac"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE (76420-819-01)", "package_ndc": "76420-819-01", "marketing_start_date": "20240626"}, {"sample": false, "description": "50 mL in 1 BOTTLE (76420-819-50)", "package_ndc": "76420-819-50", "marketing_start_date": "20240626"}, {"sample": false, "description": "75 mL in 1 BOTTLE (76420-819-75)", "package_ndc": "76420-819-75", "marketing_start_date": "20240626"}], "brand_name": "Amoxicillin", "product_id": "76420-819_1bc435f9-12b8-ccff-e063-6294a90a951a", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]"], "product_ndc": "76420-819", "generic_name": "Amoxicillin", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amoxicillin", "active_ingredients": [{"name": "AMOXICILLIN", "strength": "400 mg/5mL"}], "application_number": "ANDA065378", "marketing_category": "ANDA", "marketing_start_date": "20070326", "listing_expiration_date": "20261231"}