Betamethasone Valerate

Product NDC
53002-8450
11-digit product format
530028450
Labeler code
53002
Product ID
53002-8450_d0c7dc15-5ed5-4df1-a633-127154aeab3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Valerate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA070069
Marketing category
ANDA
Marketing start
1985-12-19
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-8450-1Betamethasone Valerate15 g in 1 TUBEOINTMENT151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-8450BETAMETHASONE VALERATE OINTMENT [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 1 package rows20220331_3cd0f7e2-e1bc-4ec7-91d3-58dfe37b04b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197409betamethasone valerate 0.1 % Topical OintmentPSN3cd0f7e2-e1bc-4ec7-91d3-58dfe37b04b51
197409betamethasone 0.001 MG/MG Topical OintmentSCD3cd0f7e2-e1bc-4ec7-91d3-58dfe37b04b51
197409betamethasone 0.1 % Topical OintmentSY3cd0f7e2-e1bc-4ec7-91d3-58dfe37b04b51
197409betamethasone 1 MG/GM (as betamethasone valerate 1.2 MG/GM) Topical OintmentSY3cd0f7e2-e1bc-4ec7-91d3-58dfe37b04b51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-8450-15300284500115 g in 1 TUBE (53002-8450-1) 15 g2022-02-010000-00-00NoNoCurrent