desonide

Generic: desonide

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name desonide
Generic Name desonide
Labeler alembic pharmaceuticals limited
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

desonide .5 mg/mL

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-550
Product ID 46708-550_07cc1eb5-c405-4e18-a83a-fd8bb6864ca9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213632
Listing Expiration 2026-12-31
Marketing Start 2025-03-26

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 46708550
Hyphenated Format 46708-550

Supplemental Identifiers

RxCUI
197572
UPC
0346708550189
UNII
J280872D1O
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 desonide (source: ndc)
Generic Name desonide (source: ndc)
Application Number ANDA213632 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (46708-550-18) / 118 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (46708-550-59) / 59 mL in 1 BOTTLE
source: ndc

Packages (2)

46708-550-18 1 BOTTLE in 1 CARTON (46708-550-18) / 118 mL in 1 BOTTLE 46708-550-59 1 BOTTLE in 1 CARTON (46708-550-59) / 59 mL in 1 BOTTLE

Ingredients (1)

desonide (.5 mg/mL)

Linked Drug Pages (1)

Desonide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "07cc1eb5-c405-4e18-a83a-fd8bb6864ca9", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0346708550189"], "unii": ["J280872D1O"], "rxcui": ["197572"], "spl_set_id": ["d210d307-72df-40fb-89c9-88663b0e4901"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (46708-550-18)  / 118 mL in 1 BOTTLE", "package_ndc": "46708-550-18", "marketing_start_date": "20250326"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (46708-550-59)  / 59 mL in 1 BOTTLE", "package_ndc": "46708-550-59", "marketing_start_date": "20250326"}], "brand_name": "Desonide", "product_id": "46708-550_07cc1eb5-c405-4e18-a83a-fd8bb6864ca9", "dosage_form": "LOTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "46708-550", "generic_name": "Desonide", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Desonide", "active_ingredients": [{"name": "DESONIDE", "strength": ".5 mg/mL"}], "application_number": "ANDA213632", "marketing_category": "ANDA", "marketing_start_date": "20250326", "listing_expiration_date": "20261231"}