hydrocortisone and acetic acid (0713-0849)

Drug Facts

Product Profile

Brand Name hydrocortisone and acetic acid

Generic Name hydrocortisone and acetic acid

Labeler cosette pharmaceuticals, inc.

Dosage Form SOLUTION

Routes

AURICULAR (OTIC)

Active Ingredients

acetic acid 20 mg/mL, hydrocortisone 10 mg/mL

Manufacturer

Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-0849

Product ID 0713-0849_106bf241-c85e-8985-e063-6394a90abffb

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA040609

Listing Expiration 2026-12-31

Marketing Start 2024-02-01

Pharmacologic Class

Established (EPC)

corticosteroid [epc]

Mechanism of Action

corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07130849

Hyphenated Format 0713-0849

Supplemental Identifiers

RxCUI

313786

UPC

0307130849098

UNII

Q40Q9N063P WI4X0X7BPJ

NUI

N0000175576 N0000175450

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 hydrocortisone and acetic acid (source: ndc)

Generic Name hydrocortisone and acetic acid (source: ndc)

Application Number ANDA040609 (source: ndc)

Routes

AURICULAR (OTIC)

source: ndc

Resolved Composition

Strengths

20 mg/mL
10 mg/mL

source: ndc

Packaging

1 BOTTLE in 1 CARTON (0713-0849-09) / 10 mL in 1 BOTTLE

source: ndc

Packages (1)

0713-0849-09 1 BOTTLE in 1 CARTON (0713-0849-09) / 10 mL in 1 BOTTLE

Ingredients (2)

acetic acid (20 mg/mL) hydrocortisone (10 mg/mL)

Linked Drug Pages (1)

hydrocortisone and acetic acid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["AURICULAR (OTIC)"], "spl_id": "106bf241-c85e-8985-e063-6394a90abffb", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0307130849098"], "unii": ["Q40Q9N063P", "WI4X0X7BPJ"], "rxcui": ["313786"], "spl_set_id": ["cef3713f-11f3-4723-9267-3d79855b49bf"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0713-0849-09)  / 10 mL in 1 BOTTLE", "package_ndc": "0713-0849-09", "marketing_start_date": "20240201"}], "brand_name": "hydrocortisone and acetic acid", "product_id": "0713-0849_106bf241-c85e-8985-e063-6394a90abffb", "dosage_form": "SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0713-0849", "generic_name": "hydrocortisone and acetic acid", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "hydrocortisone and acetic acid", "active_ingredients": [{"name": "ACETIC ACID", "strength": "20 mg/mL"}, {"name": "HYDROCORTISONE", "strength": "10 mg/mL"}], "application_number": "ANDA040609", "marketing_category": "ANDA", "marketing_start_date": "20240201", "listing_expiration_date": "20261231"}