FDA.reportPublic FDA data

Desonide Ointment, 0.05%

Product NDC
21922-004
11-digit product format
219220004
Labeler code
21922
Product ID
21922-004_545fde77-f6c2-4129-b67f-1f8eadd5efde
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desonide Ointment, 0.05%
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Encube Ethicals, Inc.
Application
ANDA210998
Marketing category
ANDA
Marketing start
2019-03-20
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 Ointment, 0.05%
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
21922-004-04Desonide Ointment, 0.05%15 g in 1 TUBEOINTMENT158
21922-004-04Desonide Ointment, 0.05%01 in 1 CARTONOINTMENT018
21922-004-07Desonide Ointment, 0.05%01 in 1 CARTONOINTMENT018
21922-004-07Desonide Ointment, 0.05%60 g in 1 TUBEOINTMENT608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21922-004-04GM - Gram21922-004567bb978-4065-4cd3-b2d6-e73c6978b1c312019-11-12
21922-004-07GM - Gram21922-0043bd3c9ee-3984-4780-97b2-ad703228da9312019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21922-004DESONIDE OINTMENT, 0.05% OINTMENT [ENCUBE ETHICALS PRIVATE LIMITED]6Current NDC, Legacy NDC, 4 package rows20241222_3d4d19d4-e47b-407e-9df4-fed5f3db91b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204135desonide 0.05 % Topical OintmentPSN1d796425-8fd6-4024-888d-0056627f7190106
204135desonide 0.05 % Topical OintmentPSN569d363a-85d3-430f-b528-55ddb4b8fbae106
204135desonide 0.0005 MG/MG Topical OintmentSCD1d796425-8fd6-4024-888d-0056627f7190106
204135desonide 0.0005 MG/MG Topical OintmentSCD569d363a-85d3-430f-b528-55ddb4b8fbae106
204135desonide 0.05 % Topical OintmentSY1d796425-8fd6-4024-888d-0056627f7190106
204135desonide 0.05 % Topical OintmentSY569d363a-85d3-430f-b528-55ddb4b8fbae106
204135desonide 0.05 % Topical OintmentPSNd5fb23d8-a39e-4cf9-9a89-2de9dfafbb4d103
204135desonide 0.0005 MG/MG Topical OintmentSCDd5fb23d8-a39e-4cf9-9a89-2de9dfafbb4d103
204135desonide 0.05 % Topical OintmentSYd5fb23d8-a39e-4cf9-9a89-2de9dfafbb4d103
204135desonide 0.05 % Topical OintmentPSN3d4d19d4-e47b-407e-9df4-fed5f3db91b98
204135desonide 0.0005 MG/MG Topical OintmentSCD3d4d19d4-e47b-407e-9df4-fed5f3db91b98
204135desonide 0.05 % Topical OintmentSY3d4d19d4-e47b-407e-9df4-fed5f3db91b98

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21922-004-04219220004041 TUBE in 1 CARTON (21922-004-04) / 15 g in 1 TUBE1 tube2019-03-200000-00-00NoNoCurrent
21922-004-07219220004071 TUBE in 1 CARTON (21922-004-07) / 60 g in 1 TUBE1 tube2019-03-200000-00-00NoNoCurrent