fluocinolone acetonide

Generic: fluocinolone acetonide

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

Drug Facts

Product Profile

Brand Name fluocinolone acetonide
Generic Name fluocinolone acetonide
Labeler cosette pharmaceuticals, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

fluocinolone acetonide .25 mg/g

Manufacturer
Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-0709
Product ID 0713-0709_ed968281-cd0d-65e8-e053-2a95a90a7054
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210747
Listing Expiration 2026-12-31
Marketing Start 2018-11-05

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 07130709
Hyphenated Format 0713-0709

Supplemental Identifiers

RxCUI
1191315
UPC
0307130709606 0307130709156
UNII
0CD5FD6S2M
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 fluocinolone acetonide (source: ndc)
Generic Name fluocinolone acetonide (source: ndc)
Application Number ANDA210747 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .25 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0713-0709-15) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0713-0709-60) / 60 g in 1 TUBE
source: ndc

Packages (2)

0713-0709-15 1 TUBE in 1 CARTON (0713-0709-15) / 15 g in 1 TUBE 0713-0709-60 1 TUBE in 1 CARTON (0713-0709-60) / 60 g in 1 TUBE

Ingredients (1)

fluocinolone acetonide (.25 mg/g)

Linked Drug Pages (1)

FLUOCINOLONE ACETONIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "ed968281-cd0d-65e8-e053-2a95a90a7054", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0307130709606", "0307130709156"], "unii": ["0CD5FD6S2M"], "rxcui": ["1191315"], "spl_set_id": ["a6e77bc5-ddb3-491a-bf16-d6d253886bb0"], "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 TUBE in 1 CARTON (0713-0709-15)  / 15 g in 1 TUBE", "package_ndc": "0713-0709-15", "marketing_start_date": "20181105"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0713-0709-60)  / 60 g in 1 TUBE", "package_ndc": "0713-0709-60", "marketing_start_date": "20181105"}], "brand_name": "FLUOCINOLONE ACETONIDE", "product_id": "0713-0709_ed968281-cd0d-65e8-e053-2a95a90a7054", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0713-0709", "generic_name": "FLUOCINOLONE ACETONIDE", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FLUOCINOLONE ACETONIDE", "active_ingredients": [{"name": "FLUOCINOLONE ACETONIDE", "strength": ".25 mg/g"}], "application_number": "ANDA210747", "marketing_category": "ANDA", "marketing_start_date": "20181105", "listing_expiration_date": "20261231"}