FDA.reportPublic FDA data

Desonide

Product NDC
46708-632
11-digit product format
467080632
Labeler code
46708
Product ID
46708-632_43c68e99-d321-43fe-befd-bae02c048841
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA214396
Marketing category
ANDA
Marketing start
2025-04-29
Substance
DESONIDE
Active strength
.5 mg/g
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/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ280872D1O
Rxcui349351

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
5dd568b3-c283-39c3-9c72-0b51d8c13e5dProduct name220201006
0d789796-3334-08b7-795a-b9c3762179bcProduct name220200506
6da396dc-a1b2-d109-14be-877a0fdbfa18Product name520200408
4fa39b20-3e53-46d7-85e4-edc2360cfdffProduct name120171115
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
a4783074-7e0b-e965-10c3-0421e26d5edeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-632-15Desonide1 in 1 CARTONCREAM11
46708-632-15Desonide15 g in 1 TUBECREAM151
46708-632-60Desonide60 g in 1 TUBECREAM601
46708-632-60Desonide1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-632DESONIDE CREAM [ALEMBIC PHARMACEUTICALS LIMITED]1Current NDC, 4 package rows20250430_99955d05-1198-4cd6-b2b4-9c328e48c0b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349351desonide 0.05 % Topical CreamPSN99955d05-1198-4cd6-b2b4-9c328e48c0b21
349351desonide 0.5 MG/ML Topical CreamSCD99955d05-1198-4cd6-b2b4-9c328e48c0b21
349351desonide 0.05 % Topical CreamSY99955d05-1198-4cd6-b2b4-9c328e48c0b21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46708-632-15467080632151 TUBE in 1 CARTON (46708-632-15) / 15 g in 1 TUBE1 tube2025-04-29NoNoCurrent
46708-632-60467080632601 TUBE in 1 CARTON (46708-632-60) / 60 g in 1 TUBE1 tube2025-04-29NoNoCurrent