hydrocortisone and acetic acid

Generic: hydrocortisone and acetic acid

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone and acetic acid
Generic Name hydrocortisone and acetic acid
Labeler sun pharmaceutical industries, inc.
Dosage Form SOLUTION
Routes
AURICULAR (OTIC)
Active Ingredients

acetic acid 20.8 mg/mL, hydrocortisone 10.4 mg/mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-3007
Product ID 51672-3007_395a20ab-856b-3f08-e063-6294a90aa48e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088759
Listing Expiration 2026-12-31
Marketing Start 2005-04-28

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 516723007
Hyphenated Format 51672-3007

Supplemental Identifiers

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 ANDA088759 (source: ndc)
Routes
AURICULAR (OTIC)
source: ndc

Resolved Composition

Strengths
  • 20.8 mg/mL
  • 10.4 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (51672-3007-1) / 10 mL in 1 BOTTLE
source: ndc

Packages (1)

51672-3007-1 1 BOTTLE in 1 CARTON (51672-3007-1) / 10 mL in 1 BOTTLE

Ingredients (2)

acetic acid (20.8 mg/mL) hydrocortisone (10.4 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": "395a20ab-856b-3f08-e063-6294a90aa48e", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q40Q9N063P", "WI4X0X7BPJ"], "spl_set_id": ["6383c722-84e2-4719-a13d-19c54e3eefff"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (51672-3007-1)  / 10 mL in 1 BOTTLE", "package_ndc": "51672-3007-1", "marketing_start_date": "20050428"}], "brand_name": "Hydrocortisone and Acetic Acid", "product_id": "51672-3007_395a20ab-856b-3f08-e063-6294a90aa48e", "dosage_form": "SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "51672-3007", "generic_name": "Hydrocortisone and Acetic Acid", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocortisone and Acetic Acid", "active_ingredients": [{"name": "ACETIC ACID", "strength": "20.8 mg/mL"}, {"name": "HYDROCORTISONE", "strength": "10.4 mg/mL"}], "application_number": "ANDA088759", "marketing_category": "ANDA", "marketing_start_date": "20050428", "listing_expiration_date": "20261231"}