amoxicillin

Generic: amoxicillin

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amoxicillin
Generic Name amoxicillin
Labeler preferred pharmaceuticals inc.
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

amoxicillin 200 mg/5mL

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8324
Product ID 68788-8324_a45cbf04-93b6-4cbb-b029-25e95cf59852
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065334
Listing Expiration 2027-12-31
Marketing Start 2023-01-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888324
Hyphenated Format 68788-8324

Supplemental Identifiers

RxCUI
308189 313850
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 ANDA065334 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/5mL
source: ndc
Packaging
  • 100 mL in 1 BOTTLE (68788-8324-1)
source: ndc

Packages (1)

68788-8324-1 100 mL in 1 BOTTLE (68788-8324-1)

Ingredients (1)

amoxicillin (200 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": "a45cbf04-93b6-4cbb-b029-25e95cf59852", "openfda": {"unii": ["804826J2HU"], "rxcui": ["308189", "313850"], "spl_set_id": ["573fcf4a-2b87-45d9-ac73-e1dec4fbc28b"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE (68788-8324-1)", "package_ndc": "68788-8324-1", "marketing_start_date": "20230119"}], "brand_name": "Amoxicillin", "product_id": "68788-8324_a45cbf04-93b6-4cbb-b029-25e95cf59852", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]"], "product_ndc": "68788-8324", "generic_name": "Amoxicillin", "labeler_name": "Preferred Pharmaceuticals Inc.", "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": "20230119", "listing_expiration_date": "20271231"}