FDA.reportPublic FDA data

Betamethasone valerate

Product NDC
62332-708
11-digit product format
623320708
Labeler code
62332
Product ID
62332-708_f9ac5a23-005f-457a-baf7-ceaf86302e7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone valerate
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA215832
Marketing category
ANDA
Marketing start
2024-08-22
Substance
BETAMETHASONE VALERATE
Active strength
1.2 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 VALERATE1.2 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9IFA5XM7R2
Rxcui1244634

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
1dbefad7-ab34-69c3-e51a-e7148aa38f70Product name520220921
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
4ea9e4b5-b452-48ad-9b25-b9a4d403405dProduct name120160310
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4f07db9b-3707-3e2c-05b5-d7852ba808c4Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-708-31Betamethasone valerate100 g in 1 CANAEROSOL, FOAM1004
62332-708-31Betamethasone valerate1 in 1 CARTONAEROSOL, FOAM14
62332-708-50Betamethasone valerate50 g in 1 CANAEROSOL, FOAM504
62332-708-50Betamethasone valerate1 in 1 CARTONAEROSOL, FOAM14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-708-31GM - Gram62332-7086d16a692-6512-4578-a624-08a4dfd1987512024-10-04
62332-708-50GM - Gram62332-708340efad5-7cd7-4550-9c7c-9dec8e76550512024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-708BETAMETHASONE VALERATE AEROSOL, FOAM [ALEMBIC PHARMACEUTICALS INC.]4Current NDC, 4 package rows20240824_3b6fa573-de04-4626-a39a-dca39def6df2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1244634betamethasone valerate 0.12 % Topical FoamPSN3b6fa573-de04-4626-a39a-dca39def6df24
1244634betamethasone valerate 1.2 MG/ML Topical FoamSCD3b6fa573-de04-4626-a39a-dca39def6df24
1244634betamethasone valerate 0.12 % Topical FoamSY3b6fa573-de04-4626-a39a-dca39def6df24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62332-708-31623320708311 CAN in 1 CARTON (62332-708-31) / 100 g in 1 CAN1 can2024-08-22NoNoHistorical
62332-708-50623320708501 CAN in 1 CARTON (62332-708-50) / 50 g in 1 CAN1 can2024-08-22NoNoHistorical