Desonide

Product NDC
46708-550
11-digit product format
467080550
Labeler code
46708
Product ID
46708-550_07cc1eb5-c405-4e18-a83a-fd8bb6864ca9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desonide
Dosage form
LOTION
Route
TOPICAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA213632
Marketing category
ANDA
Marketing start
2025-03-26
Substance
DESONIDE
Active strength
.5 mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Desonide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESONIDE.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ280872D1O
Rxcui197572

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5dd568b3-c283-39c3-9c72-0b51d8c13e5dProduct name220201006
0d789796-3334-08b7-795a-b9c3762179bcProduct name220200506
6da396dc-a1b2-d109-14be-877a0fdbfa18Product name520200408
4fa39b20-3e53-46d7-85e4-edc2360cfdffProduct name120171115
a4783074-7e0b-e965-10c3-0421e26d5edeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-550-18Desonide118 mL in 1 BOTTLELOTION1181
46708-550-18Desonide1 in 1 CARTONLOTION11
46708-550-59Desonide1 in 1 CARTONLOTION11
46708-550-59Desonide59 mL in 1 BOTTLELOTION591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-550DESONIDE LOTION [ALEMBIC PHARMACEUTICALS LIMITED]1Current NDC, 4 package rows20250327_d210d307-72df-40fb-89c9-88663b0e4901.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197572desonide 0.05 % Topical LotionPSNd210d307-72df-40fb-89c9-88663b0e49011
197572desonide 0.5 MG/ML Topical LotionSCDd210d307-72df-40fb-89c9-88663b0e49011
197572desonide 0.05 % Topical LotionSYd210d307-72df-40fb-89c9-88663b0e49011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46708-550-18467080550181 BOTTLE in 1 CARTON (46708-550-18) / 118 mL in 1 BOTTLE1 bottle2025-03-26NoNoCurrent
46708-550-59467080550591 BOTTLE in 1 CARTON (46708-550-59) / 59 mL in 1 BOTTLE1 bottle2025-03-26NoNoCurrent