FDA.reportPublic FDA data

Betamethasone Valerate

Product NDC
68788-8496
11-digit product format
687888496
Labeler code
68788
Product ID
68788-8496_5c93414e-0b79-4ecd-8760-7fa75c238edb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
betamethasone valerate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Preferred Pharmaceuticals Inc.
Application
NDA018865
Marketing category
NDA
Marketing start
2023-07-26
Substance
BETAMETHASONE VALERATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
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
Rxcui197409

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
68788-8496-1Betamethasone Valerate15 g in 1 TUBEOINTMENT155
68788-8496-4Betamethasone Valerate45 g in 1 TUBEOINTMENT455

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8496-1GM - Gram68788-8496dce5f542-5056-49f7-815a-fadd869f529212023-09-05
68788-8496-4GM - Gram68788-8496a215173d-dae1-458b-88b6-890a7413e92412023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8496BETAMETHASONE VALERATE OINTMENT [PREFERRED PHARMACEUTICALS INC.]4Current NDC, 2 package rows20250210_50d4763d-5a84-4c45-be06-040c4a527470.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197409betamethasone valerate 0.1 % Topical OintmentPSN50d4763d-5a84-4c45-be06-040c4a5274705
197409betamethasone 0.001 MG/MG Topical OintmentSCD50d4763d-5a84-4c45-be06-040c4a5274705
197409betamethasone 0.1 % Topical OintmentSY50d4763d-5a84-4c45-be06-040c4a5274705
197409betamethasone 1 MG/GM (as betamethasone valerate 1.2 MG/GM) Topical OintmentSY50d4763d-5a84-4c45-be06-040c4a5274705

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8496-16878884960115 g in 1 TUBE (68788-8496-1) 15 g2023-07-26NoNoHistorical
68788-8496-46878884960445 g in 1 TUBE (68788-8496-4) 45 g2023-07-26NoNoHistorical