amoxicillin and clavulanate potassium (69097-098)

Drug Facts

Product Profile

Brand Name amoxicillin and clavulanate potassium

Generic Name amoxicillin and clavulanate potassium

Labeler cipla usa inc.

Dosage Form SUSPENSION

Routes

ORAL

Active Ingredients

amoxicillin 250 mg/5mL, clavulanate potassium 62.5 mg/5mL

Manufacturer

Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-098

Product ID 69097-098_07e2bc58-0782-4cba-9e8d-fb9c906ab71e

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA065431

Listing Expiration 2026-12-31

Marketing Start 2024-10-28

Pharmacologic Class

Classes

penicillin-class antibacterial [epc] penicillins [cs] beta lactamase inhibitor [epc] beta lactamase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097098

Hyphenated Format 69097-098

Supplemental Identifiers

RxCUI

617322

UPC

0369097098445 0369097098087 0369097098438

UNII

804826J2HU Q42OMW3AT8

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 and clavulanate potassium (source: ndc)

Generic Name amoxicillin and clavulanate potassium (source: ndc)

Application Number ANDA065431 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

250 mg/5mL
62.5 mg/5mL

source: ndc

Packaging

150 mL in 1 BOTTLE (69097-098-08)
75 mL in 1 BOTTLE (69097-098-43)
100 mL in 1 BOTTLE (69097-098-44)

source: ndc

Packages (3)

69097-098-08 150 mL in 1 BOTTLE (69097-098-08) 69097-098-43 75 mL in 1 BOTTLE (69097-098-43) 69097-098-44 100 mL in 1 BOTTLE (69097-098-44)

Ingredients (2)

amoxicillin (250 mg/5mL) clavulanate potassium (62.5 mg/5mL)

Linked Drug Pages (1)

Amoxicillin and Clavulanate potassium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "07e2bc58-0782-4cba-9e8d-fb9c906ab71e", "openfda": {"upc": ["0369097098445", "0369097098087", "0369097098438"], "unii": ["804826J2HU", "Q42OMW3AT8"], "rxcui": ["617322"], "spl_set_id": ["db25500a-90ee-429f-991f-da511cec7882"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "150 mL in 1 BOTTLE (69097-098-08)", "package_ndc": "69097-098-08", "marketing_start_date": "20241028"}, {"sample": false, "description": "75 mL in 1 BOTTLE (69097-098-43)", "package_ndc": "69097-098-43", "marketing_start_date": "20241028"}, {"sample": false, "description": "100 mL in 1 BOTTLE (69097-098-44)", "package_ndc": "69097-098-44", "marketing_start_date": "20241028"}], "brand_name": "Amoxicillin and Clavulanate potassium", "product_id": "69097-098_07e2bc58-0782-4cba-9e8d-fb9c906ab71e", "dosage_form": "SUSPENSION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "69097-098", "generic_name": "Amoxicillin and Clavulanate Potassium", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amoxicillin and Clavulanate potassium", "active_ingredients": [{"name": "AMOXICILLIN", "strength": "250 mg/5mL"}, {"name": "CLAVULANATE POTASSIUM", "strength": "62.5 mg/5mL"}], "application_number": "ANDA065431", "marketing_category": "ANDA", "marketing_start_date": "20241028", "listing_expiration_date": "20261231"}