Clotrimazole and Betamethasone Dipropionate

Product NDC
50090-0741
11-digit product format
500900741
Labeler code
50090
Product ID
50090-0741_c81292e5-a450-429d-8909-cf6f039d9430
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clotrimazole and Betamethasone Dipropionate
Dosage form
CREAM
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA076002
Marketing category
ANDA
Marketing start
2003-12-16
Substance
BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE
Active strength
.5; 10 mg/g; mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEBETAMETHASONE DIPROPIONATE; CLOTRIMAZOLEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076002-001AB

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 UTC2026-02A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-023f01610625f2…
2019-09-15 20:21 UTC2019-09A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-02e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076002-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2002-08-02cb3db0bc1861…

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 UTC2026-02A076002-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076002-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076002-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076002-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076002-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076002-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076002-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076002-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076002-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076002-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076002-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076002-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076002-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076002-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076002-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076002-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076002-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076002-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076002-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076002-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076002-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076002-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076002-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076002-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076002-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076002-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076002-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076002-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076002-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076002-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076002-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076002-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076002-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076002-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076002-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076002-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076002-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076002-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076002-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076002-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Clotrimazole and Betamethasone Dipropionate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE.5 mg/g
BETAMETHASONE DIPROPIONATE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G07GZ97H65Internal UNII lookup
826Y60901UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308714Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5ca32ede-b546-4b65-90d6-c69add760522Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
dde7b902-54a1-627e-12f1-9e6d244ab88cProduct name420250317
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
4f07db9b-3707-3e2c-05b5-d7852ba808c4Product name120140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0741-0Clotrimazole and Betamethasone Dipropionate45 g in 1 TUBECREAM4510
50090-0741-0Clotrimazole and Betamethasone Dipropionate1 in 1 CARTONCREAM110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0741-0GM - Gram50090-074110fbe47f-2d30-4ba3-92e6-3a5210a0f5ea12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0741CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [A-S MEDICATION SOLUTIONS]10Current NDC, 2 package rows20231018_5ca32ede-b546-4b65-90d6-c69add760522.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clotrimazole/BetamethCLOTRIMAZOLE/BETAMETHDirect_Rx08901233-7d36-e5d9-e063-6394a90af33d2026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076002
application number: ANDA076002
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEBryant Ranch Prepack153fed41-6662-4ca9-802f-84b44dcb65e92025-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076002
application number: ANDA076002
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEActavis Pharma, Inc.a6ac4020-2c67-426a-8289-7e54ce43d0c92024-08-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076002
application number: ANDA076002
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEA-S Medication Solutions5ca32ede-b546-4b65-90d6-c69add7605222023-09-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076002
application number: ANDA076002
ndc (product): 50090-0741
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEProficient Rx LP3d235926-6f17-4aa5-be82-7f1b4357e2472022-06-01Adverse reactionsExact identifier
application applno (ANDA): 076002
application number: ANDA076002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308714clotrimazole 1 % / betamethasone 0.05 % Topical CreamPSN5ca32ede-b546-4b65-90d6-c69add76052210
308714betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical CreamSCD5ca32ede-b546-4b65-90d6-c69add76052210
308714betamethasone 0.05 % / clotrimazole 1 % Topical CreamSY5ca32ede-b546-4b65-90d6-c69add76052210
308714betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical CreamSY5ca32ede-b546-4b65-90d6-c69add76052210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-0741-0500900741001 TUBE in 1 CARTON (50090-0741-0) / 45 g in 1 TUBE1 tube2014-11-28NoNoCurrent