Betamethasone Dipropionate

Product NDC
0713-0759
11-digit product format
007130759
Labeler code
0713
Product ID
0713-0759_dde30d61-d029-46fe-e053-2a95a90a98b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Dipropionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA210217
Marketing category
ANDA
Marketing start
2019-05-21
Marketing end
2023-03-31
Substance
BETAMETHASONE DIPROPIONATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct0713-0759DDiscontinued by firm2026-08-03
excluded packagepackage0713-07590713-0759-15DDiscontinued by firm2026-08-03
excluded packagepackage0713-07590713-0759-37DDiscontinued by firm2026-08-03

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 1 · 36 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 packagepackage0713-0759-37d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0713-0759-15d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0713-0759-37f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0713-0759-15f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0713-0759-372ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0713-0759-152ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0713-0759-37a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0713-0759-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0713-0759-37cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0713-0759-15cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0713-0759-37cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0713-0759-15cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0713-0759-37302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0713-0759-15302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0713-0759-37ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0713-0759-15ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0713-0759-370efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0713-0759-150efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0713-0759-37ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0713-0759-15ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0713-0759-37367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0713-0759-15367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0713-0759-37557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0713-0759-15557ba5c1ecfa…9c80585c8c6e…

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
A210217-001BETAMETHASONE DIPROPIONATEBETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210217-001AB

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 UTC2026-02A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-1287673890dc5c…
2021-03-12 10:30 UTC2021-03A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-123f01610625f2…
2019-09-15 20:21 UTC2019-09A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-12b00525d2431f…
2019-07-19 19:46 UTC2019-07A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-12ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-123f0d92c62455…
2023-05-13 08:27 UTC2023-05A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-12053a50430f4f…
2023-01-26 05:58 UTC2023-01A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-12f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-12e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210217-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2018-10-12cb3db0bc1861…

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 UTC2026-02A210217-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210217-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210217-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210217-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210217-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210217-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210217-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210217-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210217-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210217-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210217-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210217-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210217-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210217-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210217-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210217-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210217-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210217-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210217-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210217-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210217-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A210217-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210217-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210217-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210217-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A210217-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A210217-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210217-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210217-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210217-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210217-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210217-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210217-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210217-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A210217-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A210217-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210217-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210217-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210217-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210217-001AB1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0759-15GM - Gram0713-07597005710c-0487-4e3e-9c63-72a66b618a5a12019-08-06
0713-0759-37GM - Gram0713-075934f5380f-e006-400b-82db-19b914538f9512019-08-06

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Betamethasone DipropionateBETAMETHASONE DIPROPIONATECosette Pharmaceuticals, Inc.4cc3b34f-9120-3362-0932-42d7024c8f892023-11-22Adverse reactionsExact identifier
application applno (ANDA): 210217
application number: ANDA210217

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0759-15007130759151 TUBE in 1 CARTON (0713-0759-15) > 15 g in 1 TUBE1 tube2019-05-210000-00-00NoNoCurrent
0713-0759-37007130759371 TUBE in 1 CARTON (0713-0759-37) > 45 g in 1 TUBE1 tube2019-05-210000-00-00NoNoCurrent