FDA.reportPublic FDA data

Betamethasone Valerate

Product NDC
68788-8450
11-digit product format
687888450
Labeler code
68788
Product ID
68788-8450_3eeca6c3-ceab-4edf-a799-fdec16cbed8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
betamethasone valerate
Dosage form
CREAM
Route
TOPICAL
Labeler
Preferred Pharmaceuticals Inc.
Application
NDA018861
Marketing category
NDA
Marketing start
2023-05-26
Substance
BETAMETHASONE VALERATE
Active strength
1 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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8450-1Betamethasone Valerate15 g in 1 TUBECREAM153
68788-8450-4Betamethasone Valerate45 g in 1 TUBECREAM453

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8450-4GM - Gram68788-84504526e056-6632-4ab7-8271-7032227fb65312023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8450BETAMETHASONE VALERATE CREAM [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 2 package rows20250210_985d1f62-4bff-4bf1-b7c7-96cb456ef83d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197407betamethasone 0.1 % Topical CreamPSN985d1f62-4bff-4bf1-b7c7-96cb456ef83d3
197407betamethasone 1 MG/ML Topical CreamSCD985d1f62-4bff-4bf1-b7c7-96cb456ef83d3
197407betamethasone 0.1 % Topical CreamSY985d1f62-4bff-4bf1-b7c7-96cb456ef83d3
197407betamethasone 1 MG/ML (as betamethasone valerate 1.2 MG/ML) Topical CreamSY985d1f62-4bff-4bf1-b7c7-96cb456ef83d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8450-16878884500115 g in 1 TUBE (68788-8450-1) 15 g2023-05-26NoNoHistorical
68788-8450-46878884500445 g in 1 TUBE (68788-8450-4) 45 g2023-05-26NoNoHistorical