FDA.reportPublic FDA data

Betamethasone Valerate

Product NDC
68071-2334
11-digit product format
680712334
Labeler code
68071
Product ID
68071-2334_b98519b2-1995-5a71-e053-2995a90ab79a
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
Marketing end
0000-00-00
Substance
BETAMETHASONE VALERATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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
68071-2334-52025-01-30C16284748780-1f386c64a-10fd-0266-e053-dadaa90a7c1aBETAMETHASONE 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.
68071-2334-52023-08-04C16284748780-1f386c64a-10fd-0266-e053-dadaa90a7c1aBETAMETHASONE 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.
68071-2334-52023-01-30C16284748780-1f386c64a-10fd-0266-e053-dadaa90a7c1aBETAMETHASONE 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
68071-2334-5Betamethasone Valerate15 g in 1 TUBECREAM152
68071-2334-5Betamethasone Valerate1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2334BETAMETHASONE VALERATE CREAM [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 2 package rows20230805_b9854715-1825-72ba-e053-2995a90a804c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
68071-2334-5680712334051 TUBE in 1 CARTON (68071-2334-5) > 15 g in 1 TUBE1 tube2021-01-220000-00-00NoNoCurrent