FDA.reportPublic FDA data

BETAMETHASONE VALERATE

Product NDC
50090-3134
11-digit product format
500903134
Labeler code
50090
Product ID
50090-3134_5eb105b7-7ccc-4598-a4a8-de3b0cd0e3b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Valerate
Dosage form
CREAM
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA072041
Marketing category
ANDA
Marketing start
1988-01-06
Substance
BETAMETHASONE VALERATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BETAMETHASONE VALERATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BETAMETHASONE VALERATE1 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
50090-3134-12024-10-13C16284748780-1f386c64a-3f38-0266-e053-dadaa90a7c1aBetamethasone Valerate Cream USP, 0.1%
50090-3134-12023-01-30C16284748780-1f386c64a-3f38-0266-e053-dadaa90a7c1aBetamethasone Valerate Cream USP, 0.1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3134-1BETAMETHASONE VALERATE45 g in 1 TUBECREAM4510
50090-3134-1BETAMETHASONE VALERATE1 in 1 CARTONCREAM110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3134-1GM - Gram50090-3134506547cc-b1a3-4d01-aead-5c4d9d86327e12018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3134BETAMETHASONE VALERATE CREAM [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 2 package rows20241015_7281d272-5342-4738-b35c-42570459e9d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197407betamethasone 0.1 % Topical CreamPSN7281d272-5342-4738-b35c-42570459e9d410
197407betamethasone 1 MG/ML Topical CreamSCD7281d272-5342-4738-b35c-42570459e9d410
197407betamethasone 0.1 % Topical CreamSY7281d272-5342-4738-b35c-42570459e9d410
197407betamethasone 1 MG/ML (as betamethasone valerate 1.2 MG/ML) Topical CreamSY7281d272-5342-4738-b35c-42570459e9d410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3134-1500903134011 TUBE in 1 CARTON (50090-3134-1) / 45 g in 1 TUBE1 tube2017-09-080000-00-00NoNoCurrent