FDA.reportPublic FDA data

Desonide

Product NDC
72578-086
11-digit product format
725780086
Labeler code
72578
Product ID
72578-086_2c331533-423f-4ad9-9026-7195e7717dd6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA210198
Marketing category
ANDA
Marketing start
2020-06-17
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
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
72578-086-01Desonide1 in 1 CARTONCREAM14
72578-086-01Desonide15 g in 1 TUBECREAM154
72578-086-02Desonide60 g in 1 TUBECREAM604
72578-086-02Desonide1 in 1 CARTONCREAM14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-086-01GM - Gram72578-086df09f144-f29b-4461-a2d0-6ab0c244ead912020-08-06
72578-086-02GM - Gram72578-0869c1fdbab-9db9-4fac-8517-c2f62215c78b12020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-086DESONIDE CREAM [VIONA PHARMACEUTICALS INC]3Current NDC, Legacy NDC, 4 package rows20221011_fdeb2a20-a612-4ae5-9178-222295271274.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349351desonide 0.05 % Topical CreamPSN0892a9fd-74e6-4a5e-8bc8-9d4146cadb61103
349351desonide 0.05 % Topical CreamPSNc70aabe7-c044-40cd-b17d-35c665160c9c103
349351desonide 0.5 MG/ML Topical CreamSCD0892a9fd-74e6-4a5e-8bc8-9d4146cadb61103
349351desonide 0.5 MG/ML Topical CreamSCDc70aabe7-c044-40cd-b17d-35c665160c9c103
349351desonide 0.05 % Topical CreamSY0892a9fd-74e6-4a5e-8bc8-9d4146cadb61103
349351desonide 0.05 % Topical CreamSYc70aabe7-c044-40cd-b17d-35c665160c9c103
349351desonide 0.05 % Topical CreamPSN217e953b-4296-4c5a-ae07-675c96c35249101
349351desonide 0.5 MG/ML Topical CreamSCD217e953b-4296-4c5a-ae07-675c96c35249101
349351desonide 0.05 % Topical CreamSY217e953b-4296-4c5a-ae07-675c96c35249101
349351desonide 0.05 % Topical CreamPSNfdeb2a20-a612-4ae5-9178-2222952712744
349351desonide 0.5 MG/ML Topical CreamSCDfdeb2a20-a612-4ae5-9178-2222952712744
349351desonide 0.05 % Topical CreamSYfdeb2a20-a612-4ae5-9178-2222952712744
349351desonide 0.05 % Topical CreamPSN0beda157-efd4-5245-e063-6394a90a69112
349351desonide 0.5 MG/ML Topical CreamSCD0beda157-efd4-5245-e063-6394a90a69112
349351desonide 0.05 % Topical CreamSY0beda157-efd4-5245-e063-6394a90a69112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72578-086-01725780086011 TUBE in 1 CARTON (72578-086-01) / 15 g in 1 TUBE1 tube2020-06-170000-00-00NoNoCurrent
72578-086-02725780086021 TUBE in 1 CARTON (72578-086-02) / 60 g in 1 TUBE1 tube2020-06-170000-00-00NoNoCurrent