amoxicillin

Generic: amoxicillin

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

Drug Facts

Product Profile

Brand Name amoxicillin
Generic Name amoxicillin
Labeler chartwell rx, llc
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

amoxicillin 400 mg/5mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-815
Product ID 62135-815_4690e611-3a29-35ce-e063-6294a90a5e9e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065319
Listing Expiration 2026-12-31
Marketing Start 2007-06-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135815
Hyphenated Format 62135-815

Supplemental Identifiers

RxCUI
308189
UPC
0362135815424
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 ANDA065319 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/5mL
source: ndc
Packaging
  • 100 mL in 1 BOTTLE (62135-815-42)
source: ndc

Packages (1)

62135-815-42 100 mL in 1 BOTTLE (62135-815-42)

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": "4690e611-3a29-35ce-e063-6294a90a5e9e", "openfda": {"upc": ["0362135815424"], "unii": ["804826J2HU"], "rxcui": ["308189"], "spl_set_id": ["1b9c0a98-2a31-4b23-ac4f-7c3f14b6f92f"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE (62135-815-42)", "package_ndc": "62135-815-42", "marketing_start_date": "20240625"}], "brand_name": "Amoxicillin", "product_id": "62135-815_4690e611-3a29-35ce-e063-6294a90a5e9e", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]"], "product_ndc": "62135-815", "generic_name": "Amoxicillin", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amoxicillin", "active_ingredients": [{"name": "AMOXICILLIN", "strength": "400 mg/5mL"}], "application_number": "ANDA065319", "marketing_category": "ANDA", "marketing_start_date": "20070618", "listing_expiration_date": "20261231"}