amcinonide

Generic: amcinonide

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

Drug Facts

Product Profile

Brand Name amcinonide
Generic Name amcinonide
Labeler fougera pharmaceuticals inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

amcinonide 1 mg/g

Manufacturer
Fougera Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0168-0278
Product ID 0168-0278_51093468-b64d-4b34-9627-8e6313c8265e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076065
Listing Expiration 2026-12-31
Marketing Start 2003-05-15

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 01680278
Hyphenated Format 0168-0278

Supplemental Identifiers

RxCUI
197327
UPC
0301680278155
UNII
423W026MA9
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 amcinonide (source: ndc)
Generic Name amcinonide (source: ndc)
Application Number ANDA076065 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0168-0278-15) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0168-0278-30) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0168-0278-60) / 60 g in 1 TUBE
source: ndc

Packages (3)

0168-0278-15 1 TUBE in 1 CARTON (0168-0278-15) / 15 g in 1 TUBE 0168-0278-30 1 TUBE in 1 CARTON (0168-0278-30) / 30 g in 1 TUBE 0168-0278-60 1 TUBE in 1 CARTON (0168-0278-60) / 60 g in 1 TUBE

Ingredients (1)

amcinonide (1 mg/g)

Linked Drug Pages (1)

Amcinonide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "51093468-b64d-4b34-9627-8e6313c8265e", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0301680278155"], "unii": ["423W026MA9"], "rxcui": ["197327"], "spl_set_id": ["8aefa477-ac2c-41c8-a807-d24522aed8f0"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Fougera Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0168-0278-15)  / 15 g in 1 TUBE", "package_ndc": "0168-0278-15", "marketing_start_date": "20030515"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0168-0278-30)  / 30 g in 1 TUBE", "package_ndc": "0168-0278-30", "marketing_start_date": "20030515"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0168-0278-60)  / 60 g in 1 TUBE", "package_ndc": "0168-0278-60", "marketing_start_date": "20030515"}], "brand_name": "Amcinonide", "product_id": "0168-0278_51093468-b64d-4b34-9627-8e6313c8265e", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0168-0278", "generic_name": "Amcinonide", "labeler_name": "Fougera Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amcinonide", "active_ingredients": [{"name": "AMCINONIDE", "strength": "1 mg/g"}], "application_number": "ANDA076065", "marketing_category": "ANDA", "marketing_start_date": "20030515", "listing_expiration_date": "20261231"}