FDA.reportPublic FDA data

Betamethasone Valerate

Product NDC
0713-0327
11-digit product format
007130327
Labeler code
0713
Product ID
0713-0327_de48a395-89de-07a5-e053-2a95a90abdf7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Valerate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA070069
Marketing category
ANDA
Marketing start
1985-12-19
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
0713-0327-15Betamethasone Valerate15 g in 1 TUBEOINTMENT159
0713-0327-15Betamethasone Valerate1 in 1 CARTONOINTMENT19
0713-0327-37Betamethasone Valerate45 g in 1 TUBEOINTMENT459
0713-0327-37Betamethasone Valerate1 in 1 CARTONOINTMENT19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0327-15GM - Gram0713-03276b0b9085-7200-43b9-878c-891022c0a1d212016-07-19
0713-0327-37GM - Gram0713-03274b8e6893-9aac-4264-8285-370ee89f02aa12016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0327BETAMETHASONE 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
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 0.1 % Topical CreamSY784476d2-5e5c-fdba-a677-8973a777b5ef9
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 CreamSY784476d2-5e5c-fdba-a677-8973a777b5ef9
197409betamethasone valerate 0.1 % Topical OintmentPSN2a64b65b-8a49-45ea-9464-2269751c075c2
197409betamethasone 0.001 MG/MG Topical OintmentSCD2a64b65b-8a49-45ea-9464-2269751c075c2
197409betamethasone 0.1 % Topical OintmentSY2a64b65b-8a49-45ea-9464-2269751c075c2
197409betamethasone 1 MG/GM (as betamethasone valerate 1.2 MG/GM) Topical OintmentSY2a64b65b-8a49-45ea-9464-2269751c075c2
197409betamethasone valerate 0.1 % Topical OintmentPSN3cd0f7e2-e1bc-4ec7-91d3-58dfe37b04b51
197409betamethasone valerate 0.1 % Topical OintmentPSN1e19dd44-06a9-03bc-e063-6294a90a3a311
197409betamethasone 0.001 MG/MG Topical OintmentSCD3cd0f7e2-e1bc-4ec7-91d3-58dfe37b04b51
197409betamethasone 0.001 MG/MG Topical OintmentSCD1e19dd44-06a9-03bc-e063-6294a90a3a311
197409betamethasone 0.1 % Topical OintmentSY3cd0f7e2-e1bc-4ec7-91d3-58dfe37b04b51
197409betamethasone 0.1 % Topical OintmentSY1e19dd44-06a9-03bc-e063-6294a90a3a311
197409betamethasone 1 MG/GM (as betamethasone valerate 1.2 MG/GM) Topical OintmentSY3cd0f7e2-e1bc-4ec7-91d3-58dfe37b04b51
197409betamethasone 1 MG/GM (as betamethasone valerate 1.2 MG/GM) Topical OintmentSY1e19dd44-06a9-03bc-e063-6294a90a3a311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0327-15007130327151 TUBE in 1 CARTON (0713-0327-15) / 15 g in 1 TUBE1 tube2015-08-270000-00-00NoNoCurrent
0713-0327-37007130327371 TUBE in 1 CARTON (0713-0327-37) / 45 g in 1 TUBE1 tube2015-08-270000-00-00NoNoCurrent