Desonide

Product NDC
0115-1517
11-digit product format
001151517
Labeler code
0115
Product ID
0115-1517_7a4ec625-b628-4a56-bf27-a11f06e8d61f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desonide
Dosage form
LOTION
Route
TOPICAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA207855
Marketing category
ANDA
Marketing start
2017-12-18
Marketing end
0000-00-00
Substance
DESONIDE
Active strength
1 mg/mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0115-1517-64Desonide1 in 1 CARTONLOTION17
0115-1517-64Desonide59 mL in 1 BOTTLELOTION597
0115-1517-65Desonide1 in 1 CARTONLOTION17
0115-1517-65Desonide118 mL in 1 BOTTLELOTION1187

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1517-64ML - Milliliter0115-1517951ed04a-3ad9-4b9b-a584-fd96ce8775f312018-01-12
0115-1517-65ML - Milliliter0115-151792e5a7a2-f438-4423-9bab-6afc037b87af12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1517DESONIDE LOTION [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]7Legacy NDC, 4 package rows20201230_99c45e54-9049-4cbc-bb8b-8b14bd97e5fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197572desonide 0.05 % Topical LotionPSN99c45e54-9049-4cbc-bb8b-8b14bd97e5fb7
197572desonide 0.5 MG/ML Topical LotionSCD99c45e54-9049-4cbc-bb8b-8b14bd97e5fb7
197572desonide 0.05 % Topical LotionSY99c45e54-9049-4cbc-bb8b-8b14bd97e5fb7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-1517-64001151517641 BOTTLE in 1 CARTON (0115-1517-64) > 59 mL in 1 BOTTLE1 bottle2017-12-180000-00-00NoNoCurrent
0115-1517-65001151517651 BOTTLE in 1 CARTON (0115-1517-65) > 118 mL in 1 BOTTLE1 bottle2017-12-180000-00-00NoNoCurrent