synalar

Generic: fluocinolone acetonide

Labeler: medimetriks pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name synalar
Generic Name fluocinolone acetonide
Labeler medimetriks pharmaceuticals, inc.
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

fluocinolone acetonide .25 mg/g

Manufacturer
Medimetriks Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43538-910
Product ID 43538-910_ba6591f7-ccd9-4269-a18f-d269f2714345
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA013960
Listing Expiration 2026-12-31
Marketing Start 2012-09-27

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 43538910
Hyphenated Format 43538-910

Supplemental Identifiers

RxCUI
1191256 1191260
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 synalar (source: ndc)
Generic Name fluocinolone acetonide (source: ndc)
Application Number NDA013960 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .25 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (43538-910-12) / 120 g in 1 TUBE
  • 6 TUBE in 1 CARTON (43538-910-99) / 3 g in 1 TUBE
source: ndc

Packages (2)

43538-910-12 1 TUBE in 1 CARTON (43538-910-12) / 120 g in 1 TUBE 43538-910-99 6 TUBE in 1 CARTON (43538-910-99) / 3 g in 1 TUBE

Ingredients (1)

fluocinolone acetonide (.25 mg/g)

Linked Drug Pages (1)

Synalar ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "ba6591f7-ccd9-4269-a18f-d269f2714345", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["0CD5FD6S2M"], "rxcui": ["1191256", "1191260"], "spl_set_id": ["d2d155cf-a635-4ab7-87de-34e90b9a74cd"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Medimetriks Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (43538-910-12)  / 120 g in 1 TUBE", "package_ndc": "43538-910-12", "marketing_start_date": "20120927"}, {"sample": false, "description": "6 TUBE in 1 CARTON (43538-910-99)  / 3 g in 1 TUBE", "package_ndc": "43538-910-99", "marketing_start_date": "20120927"}], "brand_name": "Synalar", "product_id": "43538-910_ba6591f7-ccd9-4269-a18f-d269f2714345", "dosage_form": "OINTMENT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "43538-910", "generic_name": "fluocinolone acetonide", "labeler_name": "Medimetriks Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Synalar", "active_ingredients": [{"name": "FLUOCINOLONE ACETONIDE", "strength": ".25 mg/g"}], "application_number": "NDA013960", "marketing_category": "NDA", "marketing_start_date": "20120927", "listing_expiration_date": "20261231"}