FDA.reportPublic FDA data

Betamethasone Valerate

Product NDC
68071-5224
11-digit product format
680715224
Labeler code
68071
Product ID
68071-5224_1b5915fc-b260-9b7e-e063-6294a90aec13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Valerate
Dosage form
CREAM
Route
TOPICAL
Labeler
NuCare 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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5224-52022-02-07C16284748780-1d6a99b39-6e28-a426-e053-dadaa90af4c2BETAMETHASONE VALERATE CREAM USP, 0.1% BETAMETHASONE VALERATE OINTMENT USP, 0.1% (Potency expressed as betamethasone) Rx only FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE.
68071-5224-52022-01-28C16284748780-1d6a99b39-6e28-a426-e053-dadaa90af4c2BETAMETHASONE VALERATE CREAM USP, 0.1% BETAMETHASONE VALERATE OINTMENT USP, 0.1% (Potency expressed as betamethasone) Rx only FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-5224-5Betamethasone Valerate15 g in 1 BOXCREAM153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5224BETAMETHASONE VALERATE CREAM [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240622_a2154b33-0f61-49af-e053-2995a90a1810.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-5224-56807152240515 g in 1 BOX (68071-5224-5) 15 g2020-03-300000-00-00NoNoCurrent