Clotrimazole and Betamethasone Dipropionate

Product NDC
21695-333
11-digit product format
216950333
Labeler code
21695
Product ID
21695-333_b844e453-78ff-4c5f-b541-37d33f355a3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clotrimazole and Betamethasone Dipropionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Rebel Distributors Corp
Application
ANDA075673
Marketing category
ANDA
Marketing start
2001-05-29
Marketing end
0000-00-00
Substance
CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE
Active strength
10 mg/g; mg/g
Pharmacologic classes
Azole Antifungal [EPC],Azoles [CS],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 productproduct21695-333IInactivated by FDA2026-08-03
excluded packagepackage21695-33321695-333-15IInactivated by FDA2026-08-03
excluded packagepackage21695-33321695-333-45IInactivated by FDA2026-08-03

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 packagepackage21695-333-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-333-45d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-333-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-333-45f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-333-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-333-452ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-333-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-333-45a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-333-15cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-333-45cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-333-15cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-333-45cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-333-15302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-333-45302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-333-15ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-333-45ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-333-150efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-333-450efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-333-15ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-333-45ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-333-15367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-333-45367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-333-15557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-333-45557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-333-158af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-333-458af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-333-15834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-333-45834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-333-151332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-333-451332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-333-45fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-333-15fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-333-4586f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-333-1586f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-333-45bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-333-15bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-333-458dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-333-158dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-333-45e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-333-15e2bbac7714bc…27bdfed8d636…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEBETAMETHASONE DIPROPIONATE; CLOTRIMAZOLEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075673-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-293f01610625f2…
2019-09-15 20:21 UTC2019-09A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-29cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075673-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075673-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075673-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075673-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075673-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075673-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075673-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075673-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075673-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075673-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075673-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075673-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075673-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075673-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075673-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075673-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075673-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075673-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075673-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075673-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075673-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075673-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075673-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075673-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075673-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075673-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075673-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075673-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075673-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075673-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075673-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075673-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075673-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075673-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075673-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075673-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075673-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075673-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075673-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075673-001AB1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
dde7b902-54a1-627e-12f1-9e6d244ab88cProduct name420250317
69b49899-11cf-4f7e-bd0a-7dc93b27311bProduct name320250130
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
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
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-333-15Clotrimazole and Betamethasone Dipropionate1 in 1 CARTONCREAM11
21695-333-15Clotrimazole and Betamethasone Dipropionate15 g in 1 TUBECREAM151
21695-333-45Clotrimazole and Betamethasone Dipropionate1 in 1 CARTONCREAM11
21695-333-45Clotrimazole and Betamethasone Dipropionate45 g in 1 TUBECREAM451

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-333-15GM - Gram21695-3337b756bd3-c6a8-4688-a132-2770539aeba412012-07-24
21695-333-45GM - Gram21695-3334f91f607-c958-43ac-a2bd-3e8c4c7a822e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Betamethasone DipropionateACTIVE INGREDIENT826Y60901UCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP]1
ClotrimazoleACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP]1
BetamethasoneACTIVE MOIETY9842X06Q6MCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP]1
ClotrimazoleACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP]1
CETEARETH-30INACTIVE INGREDIENT1R9DCZ5FOXCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP]1
phosphoric acidINACTIVE INGREDIENTE4GA8884NNCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP]1
sodium phosphate, monobasicINACTIVE INGREDIENT3980JIH2SWCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP]1
waterINACTIVE INGREDIENT059QF0KO0RCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-333CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP]1Legacy NDC, 4 package rows20101123_b844e453-78ff-4c5f-b541-37d33f355a3a.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEREMEDYREPACK INC.5c064fc8-0426-4608-90ee-93609a7e55472026-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075673
application number: ANDA075673
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATERedpharm Drug56cb4b1c-e0c6-25b2-e063-6394a90ac8332026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075673
application number: ANDA075673
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATESun Pharmaceutical Industries, Inc.1c18e5fc-bf82-47bc-bfd9-8d3e503569ba2026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075673
application number: ANDA075673
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATESportpharm LLC313dde2e-fb82-4786-988b-565d3e003c372026-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075673
application number: ANDA075673
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEPreferred Pharmaceuticals Inc.196e24fc-3315-4366-ad40-51b7ea54b2112026-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075673
application number: ANDA075673
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEA-S Medication Solutions2eff5585-f013-42f0-b678-bb5406e8188c2026-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075673
application number: ANDA075673
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEAdvanced Rx Pharmacy of Tennessee, LLCfe2ec7d2-23c2-e99f-e053-6294a90aa65a2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075673
application number: ANDA075673
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEA-S Medication Solutions4320f2b8-ac47-40f4-9275-e7c5506e30e42024-09-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075673
application number: ANDA075673
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATENORTHSTAR RX LLC8d03b9ba-f7a8-4fbf-9be1-83d815c2be452024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075673
application number: ANDA075673
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEA-S Medication Solutionsb3f69dc2-2b88-4866-baea-aa3b3ed84fb12023-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075673
application number: ANDA075673

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308714clotrimazole 1 % / betamethasone 0.05 % Topical CreamPSNb844e453-78ff-4c5f-b541-37d33f355a3a1
308714betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical CreamSCDb844e453-78ff-4c5f-b541-37d33f355a3a1
308714betamethasone 0.05 % / clotrimazole 1 % Topical CreamSYb844e453-78ff-4c5f-b541-37d33f355a3a1
308714betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical CreamSYb844e453-78ff-4c5f-b541-37d33f355a3a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-333-15216950333151 in 1 CARTONHistorical
21695-333-45216950333451 in 1 CARTONHistorical