BETAMETHASONE VALERATE

Product NDC
53002-9211
11-digit product format
530029211
Labeler code
53002
Product ID
53002-9211_91c09b62-ba40-4b4a-876a-ecb09c0d970b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Valerate
Dosage form
CREAM
Route
TOPICAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA072041
Marketing category
ANDA
Marketing start
1988-01-06
Marketing end
0000-00-00
Substance
BETAMETHASONE VALERATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
53002-9211-12025-01-30C16284748780-12cef2736-b4e7-d83d-e063-dadaa90ab31fBetamethasone Valerate Cream USP, 0.1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-9211-1BETAMETHASONE VALERATE15 g in 1 TUBECREAM151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-9211BETAMETHASONE VALERATE CREAM [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 1 package rows20220331_68aa1460-a6d1-4c1e-bbfb-15e95d9ee208.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197407betamethasone 0.1 % Topical CreamPSN68aa1460-a6d1-4c1e-bbfb-15e95d9ee2081
197407betamethasone 1 MG/ML Topical CreamSCD68aa1460-a6d1-4c1e-bbfb-15e95d9ee2081
197407betamethasone 0.1 % Topical CreamSY68aa1460-a6d1-4c1e-bbfb-15e95d9ee2081
197407betamethasone 1 MG/ML (as betamethasone valerate 1.2 MG/ML) Topical CreamSY68aa1460-a6d1-4c1e-bbfb-15e95d9ee2081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-9211-15300292110115 g in 1 TUBE (53002-9211-1) 15 g2022-04-010000-00-00NoNoCurrent