amcinonide

Generic: amcinonide

Labeler: solubiomix, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amcinonide
Generic Name amcinonide
Labeler solubiomix, llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

amcinonide 1 mg/g

Manufacturer
Solubiomix, LLC

Identifiers & Regulatory

Product NDC 69499-410
Product ID 69499-410_ba042715-8f24-4ca4-bb5a-42b49f8974d8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076065
Listing Expiration 2026-12-31
Marketing Start 2024-11-25

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 69499410
Hyphenated Format 69499-410

Supplemental Identifiers

RxCUI
197327
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 (69499-410-30) / 30 g in 1 TUBE
source: ndc

Packages (1)

69499-410-30 1 TUBE in 1 CARTON (69499-410-30) / 30 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": "ba042715-8f24-4ca4-bb5a-42b49f8974d8", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["423W026MA9"], "rxcui": ["197327"], "spl_set_id": ["d566e1c3-e404-4c71-b886-cc957233c1f4"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Solubiomix, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (69499-410-30)  / 30 g in 1 TUBE", "package_ndc": "69499-410-30", "marketing_start_date": "20241125"}], "brand_name": "Amcinonide", "product_id": "69499-410_ba042715-8f24-4ca4-bb5a-42b49f8974d8", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "69499-410", "generic_name": "amcinonide", "labeler_name": "Solubiomix, LLC", "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": "20241125", "listing_expiration_date": "20261231"}