amoxicillin

Generic: amoxicillin

Labeler: asclemed usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name amoxicillin
Generic Name amoxicillin
Labeler asclemed usa inc.
Dosage Form FOR SUSPENSION
Routes
ORAL
Active Ingredients

amoxicillin 400 mg/5mL

Manufacturer
ASCLEMED USA INC.

Identifiers & Regulatory

Product NDC 87063-058
Product ID 87063-058_45973812-ad2c-0c60-e063-6394a90a9ddc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA050760
Listing Expiration 2026-12-31
Marketing Start 2024-04-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 87063058
Hyphenated Format 87063-058

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 NDA050760 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/5mL
source: ndc
Packaging
  • 100 mL in 1 BOTTLE (87063-058-01)
  • 50 mL in 1 BOTTLE (87063-058-50)
  • 75 mL in 1 BOTTLE (87063-058-75)
source: ndc

Packages (3)

87063-058-01 100 mL in 1 BOTTLE (87063-058-01) 87063-058-50 50 mL in 1 BOTTLE (87063-058-50) 87063-058-75 75 mL in 1 BOTTLE (87063-058-75)

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": "45973812-ad2c-0c60-e063-6394a90a9ddc", "openfda": {"unii": ["804826J2HU"], "rxcui": ["308189"], "spl_set_id": ["08100595-e6de-4a8a-a177-a94f849bbe9f"], "manufacturer_name": ["ASCLEMED USA INC."]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE (87063-058-01)", "package_ndc": "87063-058-01", "marketing_start_date": "20251210"}, {"sample": false, "description": "50 mL in 1 BOTTLE (87063-058-50)", "package_ndc": "87063-058-50", "marketing_start_date": "20251210"}, {"sample": false, "description": "75 mL in 1 BOTTLE (87063-058-75)", "package_ndc": "87063-058-75", "marketing_start_date": "20251210"}], "brand_name": "Amoxicillin", "product_id": "87063-058_45973812-ad2c-0c60-e063-6394a90a9ddc", "dosage_form": "FOR SUSPENSION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]"], "product_ndc": "87063-058", "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": "NDA050760", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20240401", "listing_expiration_date": "20261231"}