FDA.reportPublic FDA data

Betamethasone Dipropionate

Product NDC
0713-0659
11-digit product format
007130659
Labeler code
0713
Product ID
0713-0659_0abb502d-643e-bbfc-e063-6294a90a8f61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Dipropionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA210217
Marketing category
ANDA
Marketing start
2018-10-12
Substance
BETAMETHASONE DIPROPIONATE
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
Betamethasone Dipropionate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BETAMETHASONE DIPROPIONATE.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii826Y60901U
Rxcui238920

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dde7b902-54a1-627e-12f1-9e6d244ab88cProduct name420250317
69b49899-11cf-4f7e-bd0a-7dc93b27311bProduct name320250130
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
0a2fcc35-464b-9ec2-a622-753662cdd48cProduct name320240216
6f762601-17ef-4321-8f47-77783d3c4d8bProduct name320231116
1dbefad7-ab34-69c3-e51a-e7148aa38f70Product name520220921
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
4ea9e4b5-b452-48ad-9b25-b9a4d403405dProduct name120160310
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
4f07db9b-3707-3e2c-05b5-d7852ba808c4Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0713-0659-15Betamethasone Dipropionate1 in 1 CARTONCREAM15
0713-0659-15Betamethasone Dipropionate15 g in 1 TUBECREAM155
0713-0659-37Betamethasone Dipropionate45 g in 1 TUBECREAM455
0713-0659-37Betamethasone Dipropionate1 in 1 CARTONCREAM15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0659-15GM - Gram0713-06599f834a9e-e3b3-4128-9fd2-b42b80abfd5912019-03-12
0713-0659-37GM - Gram0713-06598f90c1fc-3415-43e0-9d7d-99ba044945a612019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0659BETAMETHASONE DIPROPIONATE CREAM [COSETTE PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 4 package rows20231123_4cc3b34f-9120-3362-0932-42d7024c8f89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238920betamethasone 0.05 % Topical CreamPSN4cc3b34f-9120-3362-0932-42d7024c8f895
238920betamethasone 0.5 MG/ML Topical CreamSCD4cc3b34f-9120-3362-0932-42d7024c8f895
238920betamethasone 0.05 % Topical CreamSY4cc3b34f-9120-3362-0932-42d7024c8f895
238920betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical CreamSY4cc3b34f-9120-3362-0932-42d7024c8f895
238920betamethasone 0.05 % Topical CreamPSNd5815efe-f29c-4356-9f2e-3ec6fcd477bc1
238920betamethasone 0.5 MG/ML Topical CreamSCDd5815efe-f29c-4356-9f2e-3ec6fcd477bc1
238920betamethasone 0.05 % Topical CreamSYd5815efe-f29c-4356-9f2e-3ec6fcd477bc1
238920betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical CreamSYd5815efe-f29c-4356-9f2e-3ec6fcd477bc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0659-15007130659151 TUBE in 1 CARTON (0713-0659-15) / 15 g in 1 TUBE1 tube2018-10-120000-00-00NoNoCurrent
0713-0659-37007130659371 TUBE in 1 CARTON (0713-0659-37) / 45 g in 1 TUBE1 tube2018-10-120000-00-00NoNoCurrent