FDA.reportPublic FDA data

BETAMETHASONE VALERATE

Product NDC
68788-7451
11-digit product format
687887451
Labeler code
68788
Product ID
68788-7451_71f72484-8398-4ae4-8efb-fc3283948b30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Valerate
Dosage form
CREAM
Route
TOPICAL
Labeler
Preferred Pharmaceuticals, Inc.
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7451-1BETAMETHASONE VALERATE1 in 1 CARTONCREAM18
68788-7451-1BETAMETHASONE VALERATE15 g in 1 TUBECREAM158
68788-7451-4BETAMETHASONE VALERATE1 in 1 CARTONCREAM18
68788-7451-4BETAMETHASONE VALERATE45 g in 1 TUBECREAM458

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7451BETAMETHASONE VALERATE CREAM [PREFERRED PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 4 package rows20250210_bfa4b6f5-3b66-430a-af41-60e3f12982bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197407betamethasone 0.1 % Topical CreamPSNbfa4b6f5-3b66-430a-af41-60e3f12982bc8
197407betamethasone 1 MG/ML Topical CreamSCDbfa4b6f5-3b66-430a-af41-60e3f12982bc8
197407betamethasone 0.1 % Topical CreamSYbfa4b6f5-3b66-430a-af41-60e3f12982bc8
197407betamethasone 1 MG/ML (as betamethasone valerate 1.2 MG/ML) Topical CreamSYbfa4b6f5-3b66-430a-af41-60e3f12982bc8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7451-1687887451011 TUBE in 1 CARTON (68788-7451-1) / 15 g in 1 TUBE1 tube2019-01-310000-00-00NoNoCurrent
68788-7451-4687887451041 TUBE in 1 CARTON (68788-7451-4) / 45 g in 1 TUBE1 tube2019-01-310000-00-00NoNoCurrent