Betamethasone Valerate

Product NDC
63187-687
11-digit product format
631870687
Labeler code
63187
Product ID
63187-687_ab4967ce-4b33-43f1-838d-23695e04f9a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Valerate
Dosage form
CREAM
Route
TOPICAL
Labeler
Proficient Rx LP
Application
ANDA070050
Marketing category
ANDA
Marketing start
2002-09-01
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
No
Listing certified through
2022-12-31
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 productproduct63187-687DDiscontinued by firm2026-08-17
excluded packagepackage63187-68763187-687-15DDiscontinued by firm2026-08-17
excluded packagepackage63187-68763187-687-45DDiscontinued by firm2026-08-17

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 1 · 6 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 packagepackage63187-687-45d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-687-15d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-687-45f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-687-15f5e01cc5f278…a2eaf40c39c3…

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
A070050-001VALNACBETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALAB1984-10-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A070050-001AB

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.

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 06:07:402026-07A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-103f01610625f2…
2019-09-15 20:21 UTC2019-09A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070050-001VALNACEQ 0.1% BASECREAM / TOPICALAB1984-10-10e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A070050-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A070050-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070050-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070050-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070050-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070050-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070050-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070050-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070050-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070050-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070050-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070050-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070050-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070050-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070050-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070050-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070050-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070050-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070050-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070050-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070050-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070050-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A070050-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070050-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070050-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070050-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A070050-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A070050-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070050-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070050-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070050-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070050-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070050-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070050-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070050-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A070050-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A070050-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070050-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070050-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070050-001AB1e64feba35796…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-687BETAMETHASONE VALERATE CREAM [PROFICIENT RX LP]3Legacy NDC20210112_c5b39a38-fe64-43db-a15c-5c3e24c783a7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-687-15631870687151 TUBE in 1 CARTON (63187-687-15) > 15 g in 1 TUBE1 tube2016-04-010000-00-00NoNoCurrent
63187-687-45631870687451 TUBE in 1 CARTON (63187-687-45) > 45 g in 1 TUBE1 tube2016-04-010000-00-00NoNoCurrent