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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215832-001BETAMETHASONE VALERATEBETAMETHASONE VALERATE0.12%AEROSOL, FOAM / TOPICALAB2024-08-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A215832-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A215832-001BETAMETHASONE VALERATE0.12%AEROSOL, FOAM / TOPICALAB2024-08-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215832-001BETAMETHASONE VALERATE0.12%AEROSOL, FOAM / TOPICALAB2024-08-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215832-001BETAMETHASONE VALERATE0.12%AEROSOL, FOAM / TOPICALAB2024-08-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A215832-001BETAMETHASONE VALERATE0.12%AEROSOL, FOAM / TOPICALAB2024-08-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215832-001BETAMETHASONE VALERATE0.12%AEROSOL, FOAM / TOPICALAB2024-08-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215832-001BETAMETHASONE VALERATE0.12%AEROSOL, FOAM / TOPICALAB2024-08-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215832-001BETAMETHASONE VALERATE0.12%AEROSOL, FOAM / TOPICALAB2024-08-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215832-001BETAMETHASONE VALERATE0.12%AEROSOL, FOAM / TOPICALAB2024-08-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215832-001BETAMETHASONE VALERATE0.12%AEROSOL, FOAM / TOPICALAB2024-08-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215832-001BETAMETHASONE VALERATE0.12%AEROSOL, FOAM / TOPICALAB2024-08-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215832-001BETAMETHASONE VALERATE0.12%AEROSOL, FOAM / TOPICALAB2024-08-22d06236e962d9…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215832-001BETAMETHASONE VALERATE0.12%AEROSOL, FOAM / TOPICALAB2024-08-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A215832-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215832-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215832-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215832-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215832-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215832-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215832-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215832-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215832-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215832-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215832-001AB1d06236e962d9…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215832-001AB1a50c72e98297…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9IFA5XM7R2Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1244634Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3b6fa573-de04-4626-a39a-dca39def6df2Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Betamethasone valerateBETAMETHASONE VALERATEAlembic Pharmaceuticals Limited75d70e76-023c-4a00-954d-79a697bed80f2025-09-25Adverse reactionsExact identifier
application applno (ANDA): 215832
application number: ANDA215832
Betamethasone valerateBETAMETHASONE VALERATEAlembic Pharmaceuticals Inc.3b6fa573-de04-4626-a39a-dca39def6df22024-08-23Adverse reactionsExact identifier
application applno (ANDA): 215832
application number: ANDA215832
ndc (product): 62332-708

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 can2024-08-22NoNoCurrent
62332-708-50623320708501 CAN in 1 CARTON (62332-708-50) / 50 g in 1 CAN1 can2024-08-22NoNoCurrent