FDA.reportPublic FDA data

Betamethasone Valerate

Product NDC
0713-0326
11-digit product format
007130326
Labeler code
0713
Product ID
0713-0326_de48a395-89de-07a5-e053-2a95a90abdf7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Valerate
Dosage form
CREAM
Route
TOPICAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
NDA018642
Marketing category
NDA
Marketing start
1983-03-24
Substance
BETAMETHASONE VALERATE
Active strength
1.2 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 Valerate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BETAMETHASONE VALERATE1.2 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9IFA5XM7R2
Rxcui197407, 197409

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
0713-0326-15Betamethasone Valerate1 in 1 CARTONCREAM19
0713-0326-15Betamethasone Valerate15 g in 1 TUBECREAM159
0713-0326-37Betamethasone Valerate1 in 1 CARTONCREAM19
0713-0326-37Betamethasone Valerate45 g in 1 TUBECREAM459

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0326-15GM - Gram0713-0326f5d86fe2-9b5f-417d-bebf-926152b18bb812017-09-11
0713-0326-37GM - Gram0713-0326ec6d45db-5604-4d4a-a39e-8522231045c012017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0326BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT [COSETTE PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 4 package rows20220616_784476d2-5e5c-fdba-a677-8973a777b5ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197407betamethasone 0.1 % Topical CreamPSN784476d2-5e5c-fdba-a677-8973a777b5ef9
197407betamethasone 0.1 % Topical CreamPSNf8711d17-de6a-45e3-8027-b650308207ed9
197407betamethasone 0.1 % Topical CreamPSNd265d143-343f-41ec-9cb4-18d83edb772b9
197409betamethasone valerate 0.1 % Topical OintmentPSN784476d2-5e5c-fdba-a677-8973a777b5ef9
197409betamethasone 0.001 MG/MG Topical OintmentSCD784476d2-5e5c-fdba-a677-8973a777b5ef9
197407betamethasone 1 MG/ML Topical CreamSCD784476d2-5e5c-fdba-a677-8973a777b5ef9
197407betamethasone 1 MG/ML Topical CreamSCDf8711d17-de6a-45e3-8027-b650308207ed9
197407betamethasone 1 MG/ML Topical CreamSCDd265d143-343f-41ec-9cb4-18d83edb772b9
197407betamethasone 0.1 % Topical CreamSY784476d2-5e5c-fdba-a677-8973a777b5ef9
197407betamethasone 0.1 % Topical CreamSYf8711d17-de6a-45e3-8027-b650308207ed9
197407betamethasone 0.1 % Topical CreamSYd265d143-343f-41ec-9cb4-18d83edb772b9
197409betamethasone 0.1 % Topical OintmentSY784476d2-5e5c-fdba-a677-8973a777b5ef9
197409betamethasone 1 MG/GM (as betamethasone valerate 1.2 MG/GM) Topical OintmentSY784476d2-5e5c-fdba-a677-8973a777b5ef9
197407betamethasone 1 MG/ML (as betamethasone valerate 1.2 MG/ML) Topical CreamSYf8711d17-de6a-45e3-8027-b650308207ed9
197407betamethasone 1 MG/ML (as betamethasone valerate 1.2 MG/ML) Topical CreamSYd265d143-343f-41ec-9cb4-18d83edb772b9
197407betamethasone 1 MG/ML (as betamethasone valerate 1.2 MG/ML) Topical CreamSY784476d2-5e5c-fdba-a677-8973a777b5ef9
197407betamethasone 0.1 % Topical CreamPSNa2154b33-0f61-49af-e053-2995a90a18103
197407betamethasone 1 MG/ML Topical CreamSCDa2154b33-0f61-49af-e053-2995a90a18103
197407betamethasone 0.1 % Topical CreamSYa2154b33-0f61-49af-e053-2995a90a18103
197407betamethasone 1 MG/ML (as betamethasone valerate 1.2 MG/ML) Topical CreamSYa2154b33-0f61-49af-e053-2995a90a18103
197407betamethasone 0.1 % Topical CreamPSNb9854715-1825-72ba-e053-2995a90a804c2
197407betamethasone 1 MG/ML Topical CreamSCDb9854715-1825-72ba-e053-2995a90a804c2
197407betamethasone 0.1 % Topical CreamSYb9854715-1825-72ba-e053-2995a90a804c2
197407betamethasone 1 MG/ML (as betamethasone valerate 1.2 MG/ML) Topical CreamSYb9854715-1825-72ba-e053-2995a90a804c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0326-15007130326151 TUBE in 1 CARTON (0713-0326-15) / 15 g in 1 TUBE1 tube2015-08-270000-00-00NoNoCurrent
0713-0326-37007130326371 TUBE in 1 CARTON (0713-0326-37) / 45 g in 1 TUBE1 tube2015-08-270000-00-00NoNoCurrent