FDA.reportPublic FDA data

Desonide

Product NDC
62332-485
11-digit product format
623320485
Labeler code
62332
Product ID
62332-485_8c111579-9635-4d85-b10d-e42399a751ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA212473
Marketing category
ANDA
Marketing start
2019-10-24
Substance
DESONIDE
Active strength
.5 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Desonide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESONIDE.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ280872D1O
Rxcui204135

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
62332-485-15Desonide1 in 1 CARTONOINTMENT18
62332-485-15Desonide15 g in 1 TUBEOINTMENT158
62332-485-60Desonide1 in 1 CARTONOINTMENT18
62332-485-60Desonide60 g in 1 TUBEOINTMENT608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-485-15GM - Gram62332-485ffd67239-20d6-43cf-8e83-02b27434088612020-01-03
62332-485-60GM - Gram62332-4857f01f1c5-0b7d-439a-8926-e92a61a7380112020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-485DESONIDE OINTMENT [ALEMBIC PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 4 package rows20230721_9eade7ae-effc-49b5-af7d-8caa183ff252.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204135desonide 0.05 % Topical OintmentPSN9eade7ae-effc-49b5-af7d-8caa183ff2528
204135desonide 0.0005 MG/MG Topical OintmentSCD9eade7ae-effc-49b5-af7d-8caa183ff2528
204135desonide 0.05 % Topical OintmentSY9eade7ae-effc-49b5-af7d-8caa183ff2528

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-485-15623320485151 TUBE in 1 CARTON (62332-485-15) / 15 g in 1 TUBE1 tube2019-10-240000-00-00NoNoCurrent
62332-485-60623320485601 TUBE in 1 CARTON (62332-485-60) / 60 g in 1 TUBE1 tube2019-10-240000-00-00NoNoCurrent