amoxicillin

Generic: amoxicillin

Labeler: usantibiotics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

amoxicillin 500 mg/1

Manufacturer
USAntibiotics, LLC

Identifiers & Regulatory

Product NDC 81964-350
Product ID 81964-350_3596a066-4a99-1e8b-e063-6294a90a7346
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062216
Listing Expiration 2026-12-31
Marketing Start 2025-05-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81964350
Hyphenated Format 81964-350

Supplemental Identifiers

RxCUI
308182 308191
UPC
0381964350982 0381964350104 0381964225013 0381964225051 0381964350609
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 ANDA062216 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (81964-350-10)
  • 60 CAPSULE in 1 BOTTLE (81964-350-60)
  • 8 CAPSULE in 1 PAIL (81964-350-98)
source: ndc

Packages (3)

81964-350-10 100 CAPSULE in 1 BOTTLE (81964-350-10) 81964-350-60 60 CAPSULE in 1 BOTTLE (81964-350-60) 81964-350-98 8 CAPSULE in 1 PAIL (81964-350-98)

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": "3596a066-4a99-1e8b-e063-6294a90a7346", "openfda": {"upc": ["0381964350982", "0381964350104", "0381964225013", "0381964225051", "0381964350609"], "unii": ["804826J2HU"], "rxcui": ["308182", "308191"], "spl_set_id": ["110ba6b1-f175-48a1-8e30-616c02212538"], "manufacturer_name": ["USAntibiotics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (81964-350-10)", "package_ndc": "81964-350-10", "marketing_start_date": "20250515"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (81964-350-60)", "package_ndc": "81964-350-60", "marketing_start_date": "20250515"}, {"sample": false, "description": "8 CAPSULE in 1 PAIL (81964-350-98)", "package_ndc": "81964-350-98", "marketing_start_date": "20250515"}], "brand_name": "AMOXICILLIN", "product_id": "81964-350_3596a066-4a99-1e8b-e063-6294a90a7346", "dosage_form": "CAPSULE", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]"], "product_ndc": "81964-350", "generic_name": "Amoxicillin", "labeler_name": "USAntibiotics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMOXICILLIN", "active_ingredients": [{"name": "AMOXICILLIN", "strength": "500 mg/1"}], "application_number": "ANDA062216", "marketing_category": "ANDA", "marketing_start_date": "20250515", "listing_expiration_date": "20261231"}