Betamethasone Dipropionate

Product NDC
0168-0266
11-digit product format
001680266
Labeler code
0168
Product ID
0168-0266_70a6cd27-7b38-4928-8a8b-eb334960ef5e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Dipropionate
Dosage form
GEL
Route
TOPICAL
Labeler
E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc.
Application
ANDA075276
Marketing category
ANDA
Marketing start
2003-05-13
Marketing end
0000-00-00
Substance
BETAMETHASONE DIPROPIONATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct0168-0266DDiscontinued by firm2026-08-17
excluded packagepackage0168-02660168-0266-15DDiscontinued by firm2026-08-17
excluded packagepackage0168-02660168-0266-50DDiscontinued 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 · 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 packagepackage0168-0266-50d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0168-0266-15d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0168-0266-50f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0168-0266-15f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0168-0266-502ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0168-0266-152ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0168-0266-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0168-0266-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0168-0266-50cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0168-0266-15cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0168-0266-50cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0168-0266-15cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0168-0266-50302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0168-0266-15302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0168-0266-50ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0168-0266-15ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0168-0266-500efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0168-0266-150efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0168-0266-50ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0168-0266-15ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0168-0266-50367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0168-0266-15367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0168-0266-50557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0168-0266-15557ba5c1ecfa…9c80585c8c6e…

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
A075276-001BETAMETHASONE DIPROPIONATEBETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075276-001AB

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 06:07:402026-07A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-133f01610625f2…
2019-09-15 20:21 UTC2019-09A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075276-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEGEL, AUGMENTED / TOPICALABRS2003-05-13e64feba35796…

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 06:07:402026-07A075276-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075276-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075276-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075276-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075276-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075276-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075276-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075276-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075276-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075276-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075276-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075276-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075276-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075276-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075276-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075276-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075276-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075276-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075276-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075276-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075276-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075276-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075276-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075276-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075276-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075276-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075276-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075276-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075276-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075276-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075276-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075276-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075276-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075276-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075276-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075276-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075276-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075276-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075276-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075276-001AB1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
69b49899-11cf-4f7e-bd0a-7dc93b27311bProduct name320250130
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BETAMETHASONE DIPROPIONATEACTIVE INGREDIENT826Y60901UBETAMETHASONE DIPROPIONATE GEL [PHYSICIANS TOTAL CARE, INC.]2
BETAMETHASONE DIPROPIONATEACTIVE MOIETY826Y60901UBETAMETHASONE DIPROPIONATE GEL [PHYSICIANS TOTAL CARE, INC.]2
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27EBETAMETHASONE DIPROPIONATE GEL [PHYSICIANS TOTAL CARE, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BETAMETHASONE DIPROPIONATE GEL [PHYSICIANS TOTAL CARE, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBETAMETHASONE DIPROPIONATE GEL [PHYSICIANS TOTAL CARE, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RBETAMETHASONE DIPROPIONATE GEL [PHYSICIANS TOTAL CARE, INC.]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848208betamethasone dipropionate 0.05 % Augmented Topical GelPSN73303330-a488-404f-bb0c-08c1d24a10632
848208Augmented betamethasone 0.0005 MG/MG Topical GelSCD73303330-a488-404f-bb0c-08c1d24a10632
848208augmented betamethasone 0.05 % Topical GelSY73303330-a488-404f-bb0c-08c1d24a10632
848208betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical GelSY73303330-a488-404f-bb0c-08c1d24a10632