Betamethasone Valerate

Product NDC
21695-584
11-digit product format
216950584
Labeler code
21695
Product ID
21695-584_f242cdf5-6921-431f-8add-4d17887ebc93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Valerate
Dosage form
CREAM
Route
TOPICAL
Labeler
Rebel Distributors Corp.
Application
ANDA070062
Marketing category
ANDA
Marketing start
1985-05-14
Marketing end
0000-00-00
Substance
BETAMETHASONE VALERATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-584IInactivated by FDA2026-08-17
excluded packagepackage21695-58421695-584-15IInactivated by FDA2026-08-17
excluded packagepackage21695-58421695-584-45IInactivated by FDA2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 66 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-584-45d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-584-15d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-584-45f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-584-15f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-584-452ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-584-152ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-584-45a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-584-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-584-45cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-584-15cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-584-45cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-584-15cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-584-45302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-584-15302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-584-45ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-584-15ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-584-450efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-584-150efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-584-45ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-584-15ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-584-45367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-584-15367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-584-45557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-584-15557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-584-458af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-584-158af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-584-45834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-584-15834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-584-451332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-584-151332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-584-45fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-584-15fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-584-4586f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-584-1586f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-584-45bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-584-15bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-584-458dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-584-158dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-584-45e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-584-15e2bbac7714bc…27bdfed8d636…

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
A070062-001BETAMETHASONE VALERATEBETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-14

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-143f01610625f2…
2019-09-15 20:21 UTC2019-09A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070062-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICAL1985-05-14e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dde7b902-54a1-627e-12f1-9e6d244ab88cProduct name420250317
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
4f07db9b-3707-3e2c-05b5-d7852ba808c4Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-584-152019-09-24C16284748780-1934fe258-4c50-48b1-e053-8cdaa90a720aBetamethasone Valerate Cream USP, 0.1%
21695-584-452019-09-24C16284748780-1934fe258-4c50-48b1-e053-8cdaa90a720aBetamethasone Valerate Cream USP, 0.1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-584-15Betamethasone Valerate1 in 1 CARTONCREAM11
21695-584-15Betamethasone Valerate15 g in 1 TUBECREAM151
21695-584-45Betamethasone Valerate45 g in 1 TUBECREAM451
21695-584-45Betamethasone Valerate1 in 1 CARTONCREAM11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-584-15GM - Gram21695-584e27ebeca-55c8-4475-a8b2-d6870d063f7d12012-07-24
21695-584-45GM - Gram21695-584523a4d1e-31db-418d-9e10-5797a62a3bd812012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-584BETAMETHASONE VALERATE CREAM [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 4 package rows20101119_f242cdf5-6921-431f-8add-4d17887ebc93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197407betamethasone 0.1 % Topical CreamPSNf242cdf5-6921-431f-8add-4d17887ebc931
197407betamethasone 1 MG/ML Topical CreamSCDf242cdf5-6921-431f-8add-4d17887ebc931
197407betamethasone 0.1 % Topical CreamSYf242cdf5-6921-431f-8add-4d17887ebc931
197407betamethasone 1 MG/ML (as betamethasone valerate 1.2 MG/ML) Topical CreamSYf242cdf5-6921-431f-8add-4d17887ebc931

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-584-15216950584151 in 1 CARTONHistorical
21695-584-452169505844545 g in 1 TUBE45 gHistorical