amoxicillin

Generic: amoxicillin

Labeler: usantibiotics, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name amoxicillin
Generic Name amoxicillin
Labeler usantibiotics, llc
Dosage Form FOR SUSPENSION
Routes
ORAL
Active Ingredients

amoxicillin 400 mg/5mL

Manufacturer
USAntibiotics, LLC

Identifiers & Regulatory

Product NDC 81964-207
Product ID 81964-207_38f95a24-c32b-03cc-e063-6394a90aa51e
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 81964207
Hyphenated Format 81964-207

Supplemental Identifiers

RxCUI
308189
UPC
0381964207521 0381964207514 0381964207507
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 NDA050760 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/5mL
source: ndc
Packaging
  • 50 mL in 1 BOTTLE (81964-207-50)
  • 75 mL in 1 BOTTLE (81964-207-51)
  • 100 mL in 1 BOTTLE (81964-207-52)
source: ndc

Packages (3)

81964-207-50 50 mL in 1 BOTTLE (81964-207-50) 81964-207-51 75 mL in 1 BOTTLE (81964-207-51) 81964-207-52 100 mL in 1 BOTTLE (81964-207-52)

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": "38f95a24-c32b-03cc-e063-6394a90aa51e", "openfda": {"upc": ["0381964207521", "0381964207514", "0381964207507"], "unii": ["804826J2HU"], "rxcui": ["308189"], "spl_set_id": ["06e5c07d-d95c-4955-8d35-a4703ca2359e"], "manufacturer_name": ["USAntibiotics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 mL in 1 BOTTLE (81964-207-50)", "package_ndc": "81964-207-50", "marketing_start_date": "20240401"}, {"sample": false, "description": "75 mL in 1 BOTTLE (81964-207-51)", "package_ndc": "81964-207-51", "marketing_start_date": "20240401"}, {"sample": false, "description": "100 mL in 1 BOTTLE (81964-207-52)", "package_ndc": "81964-207-52", "marketing_start_date": "20240401"}], "brand_name": "Amoxicillin", "product_id": "81964-207_38f95a24-c32b-03cc-e063-6394a90aa51e", "dosage_form": "FOR SUSPENSION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]"], "product_ndc": "81964-207", "generic_name": "Amoxicillin", "labeler_name": "USAntibiotics, LLC", "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"}