amoxicillin

Generic: amoxicillin

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amoxicillin
Generic Name amoxicillin
Labeler aurobindo pharma limited
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

amoxicillin 200 mg/5mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-070
Product ID 65862-070_3e3ca279-1838-4348-a01c-df10a8bcb8b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065334
Listing Expiration 2026-12-31
Marketing Start 2006-12-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862070
Hyphenated Format 65862-070

Supplemental Identifiers

RxCUI
308189 313850
UPC
0365862071019 0365862070012
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 ANDA065334 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/5mL
source: ndc
Packaging
  • 100 mL in 1 BOTTLE (65862-070-01)
  • 50 mL in 1 BOTTLE (65862-070-50)
  • 75 mL in 1 BOTTLE (65862-070-75)
source: ndc

Packages (3)

Ingredients (1)

amoxicillin (200 mg/5mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "3e3ca279-1838-4348-a01c-df10a8bcb8b9", "openfda": {"upc": ["0365862071019", "0365862070012"], "unii": ["804826J2HU"], "rxcui": ["308189", "313850"], "spl_set_id": ["3cacd754-73f4-496e-a529-9ca39fa6692d"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE (65862-070-01)", "package_ndc": "65862-070-01", "marketing_start_date": "20061228"}, {"sample": false, "description": "50 mL in 1 BOTTLE (65862-070-50)", "package_ndc": "65862-070-50", "marketing_start_date": "20061228"}, {"sample": false, "description": "75 mL in 1 BOTTLE (65862-070-75)", "package_ndc": "65862-070-75", "marketing_start_date": "20061228"}], "brand_name": "Amoxicillin", "product_id": "65862-070_3e3ca279-1838-4348-a01c-df10a8bcb8b9", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]"], "product_ndc": "65862-070", "generic_name": "Amoxicillin", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amoxicillin", "active_ingredients": [{"name": "AMOXICILLIN", "strength": "200 mg/5mL"}], "application_number": "ANDA065334", "marketing_category": "ANDA", "marketing_start_date": "20061228", "listing_expiration_date": "20261231"}