Clotrimazole and Betamethasone Dipropionate

Product NDC: 68462-298
11-digit product format: 684620298
Labeler code: 68462
Product ID: 68462-298_2fc6dcb9-879f-4d6e-8194-4a30af922986
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clotrimazole and Betamethasone Dipropionate
Dosage form: CREAM
Route: TOPICAL
Labeler: Glenmark Pharmaceuticals Inc. USA
Application: ANDA202894
Marketing category: ANDA
Marketing start: 2015-11-06
Substance: CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE
Active strength: 10; .5 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 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE	EQ 0.05% BASE;1%	CREAM / TOPICAL			2015-10-30

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL		2015-10-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL		2015-10-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL		2015-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL		2015-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A202894-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202894-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202894-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202894-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202894-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202894-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202894-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202894-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202894-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202894-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202894-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202894-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202894-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202894-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202894-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202894-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202894-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202894-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202894-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202894-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202894-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202894-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202894-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202894-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202894-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202894-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202894-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202894-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202894-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202894-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202894-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202894-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202894-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202894-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202894-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202894-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202894-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202894-001	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLOTRIMAZOLE	10 mg/g
BETAMETHASONE DIPROPIONATE	.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G07GZ97H65	Internal UNII lookup
826Y60901U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
8dcd24cb-e568-428a-88ac-737d115cc54d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b64d2752-34ef-378a-1f4f-8bff32b0d1ae	Product name	4	20250626
dde7b902-54a1-627e-12f1-9e6d244ab88c	Product name	4	20250317
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
69b49899-11cf-4f7e-bd0a-7dc93b27311b	Product name	3	20250130
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9	Product name	2	20250121
bbdc14c7-d940-43b5-a2f7-36c425991f3c	Product name	1	20240320
0a2fcc35-464b-9ec2-a622-753662cdd48c	Product name	3	20240216
6f762601-17ef-4321-8f47-77783d3c4d8b	Product name	3	20231116
1dbefad7-ab34-69c3-e51a-e7148aa38f70	Product name	5	20220921
7fea2046-07a9-4bb6-9409-828ac6f1f6df	Product name	1	20210201
f059f1a2-0e64-4839-9a7f-42687c91a44b	Product name	1	20201007
4ea9e4b5-b452-48ad-9b25-b9a4d403405d	Product name	1	20160310
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6	Product name	2	20151106
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
4f07db9b-3707-3e2c-05b5-d7852ba808c4	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951c	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68462-298-17	Clotrimazole and Betamethasone Dipropionate	15 g in 1 TUBE	CREAM	15		5
68462-298-55	Clotrimazole and Betamethasone Dipropionate	45 g in 1 TUBE	CREAM	45		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-298-17	GM - Gram	68462-298	e7d77887-7d72-47bb-81a1-3c254cad8509	1	2015-12-02
68462-298-55	GM - Gram	68462-298	bce53ca3-855c-4618-80fe-52f005a1ad81	1	2015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BETAMETHASONE DIPROPIONATE	ACTIVE INGREDIENT	826Y60901U	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [GLENMARK PHARMACEUTICALS INC. USA]	1
CLOTRIMAZOLE	ACTIVE INGREDIENT	G07GZ97H65	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [GLENMARK PHARMACEUTICALS INC. USA]	1
BETAMETHASONE	ACTIVE MOIETY	9842X06Q6M	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [GLENMARK PHARMACEUTICALS INC. USA]	1
CLOTRIMAZOLE	ACTIVE MOIETY	G07GZ97H65	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [GLENMARK PHARMACEUTICALS INC. USA]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [GLENMARK PHARMACEUTICALS INC. USA]	1
CETEARETH-30	INACTIVE INGREDIENT	1R9DCZ5FOX	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [GLENMARK PHARMACEUTICALS INC. USA]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [GLENMARK PHARMACEUTICALS INC. USA]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [GLENMARK PHARMACEUTICALS INC. USA]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [GLENMARK PHARMACEUTICALS INC. USA]	1
PHOSPHORIC ACID	INACTIVE INGREDIENT	E4GA8884NN	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [GLENMARK PHARMACEUTICALS INC. USA]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [GLENMARK PHARMACEUTICALS INC. USA]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [GLENMARK PHARMACEUTICALS INC. USA]	1
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	INACTIVE INGREDIENT	593YOG76RN	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [GLENMARK PHARMACEUTICALS INC. USA]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [GLENMARK PHARMACEUTICALS INC. USA]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-298	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [GLENMARK PHARMACEUTICALS INC. USA]	5	Current NDC, Legacy NDC, 2 package rows	20240104_8dcd24cb-e568-428a-88ac-737d115cc54d.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Direct Rx	bbf26437-c9b4-d8e6-e053-2a95a90a0062	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202894 application number: ANDA202894
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	NuCare Pharmaceuticals,Inc.	5cc511e4-3e7d-70d6-e053-2a91aa0a8044	2024-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202894 application number: ANDA202894
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Proficient Rx LP	c6e4bf5f-f6d6-489e-9286-c30568c601b7	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202894 application number: ANDA202894
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Glenmark Pharmaceuticals Inc. USA	8dcd24cb-e568-428a-88ac-737d115cc54d	2020-11-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202894 application number: ANDA202894 ndc (product): 68462-298

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G07GZ97H65	CLOTRIMAZOLE	23593-75-1	CLOTRIMAZOLE
826Y60901U	BETAMETHASONE DIPROPIONATE	5593-20-4	BETAMETHASONE DIPROPIONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308714	clotrimazole 1 % / betamethasone 0.05 % Topical Cream	PSN	8dcd24cb-e568-428a-88ac-737d115cc54d	5
308714	clotrimazole 1 % / betamethasone 0.05 % Topical Cream	PSN	5cc511e4-3e7d-70d6-e053-2a91aa0a8044	5
308714	betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical Cream	SCD	8dcd24cb-e568-428a-88ac-737d115cc54d	5
308714	betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical Cream	SCD	5cc511e4-3e7d-70d6-e053-2a91aa0a8044	5
308714	betamethasone 0.05 % / clotrimazole 1 % Topical Cream	SY	8dcd24cb-e568-428a-88ac-737d115cc54d	5
308714	betamethasone 0.05 % / clotrimazole 1 % Topical Cream	SY	5cc511e4-3e7d-70d6-e053-2a91aa0a8044	5
308714	betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical Cream	SY	8dcd24cb-e568-428a-88ac-737d115cc54d	5
308714	betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical Cream	SY	5cc511e4-3e7d-70d6-e053-2a91aa0a8044	5
308714	clotrimazole 1 % / betamethasone 0.05 % Topical Cream	PSN	119377f2-dca4-42e4-acf7-6ff56916696a	3
308714	betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical Cream	SCD	119377f2-dca4-42e4-acf7-6ff56916696a	3
308714	betamethasone 0.05 % / clotrimazole 1 % Topical Cream	SY	119377f2-dca4-42e4-acf7-6ff56916696a	3
308714	betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical Cream	SY	119377f2-dca4-42e4-acf7-6ff56916696a	3
308714	clotrimazole 1 % / betamethasone 0.05 % Topical Cream	PSN	bbf26437-c9b4-d8e6-e053-2a95a90a0062	2
308714	betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical Cream	SCD	bbf26437-c9b4-d8e6-e053-2a95a90a0062	2
308714	betamethasone 0.05 % / clotrimazole 1 % Topical Cream	SY	bbf26437-c9b4-d8e6-e053-2a95a90a0062	2
308714	betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical Cream	SY	bbf26437-c9b4-d8e6-e053-2a95a90a0062	2
308714	clotrimazole 1 % / betamethasone 0.05 % Topical Cream	PSN	239fa275-373a-2a59-e063-6394a90afdcb	1
308714	clotrimazole 1 % / betamethasone 0.05 % Topical Cream	PSN	c6e4bf5f-f6d6-489e-9286-c30568c601b7	1
308714	betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical Cream	SCD	239fa275-373a-2a59-e063-6394a90afdcb	1
308714	betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical Cream	SCD	c6e4bf5f-f6d6-489e-9286-c30568c601b7	1
308714	betamethasone 0.05 % / clotrimazole 1 % Topical Cream	SY	239fa275-373a-2a59-e063-6394a90afdcb	1
308714	betamethasone 0.05 % / clotrimazole 1 % Topical Cream	SY	c6e4bf5f-f6d6-489e-9286-c30568c601b7	1
308714	betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical Cream	SY	239fa275-373a-2a59-e063-6394a90afdcb	1
308714	betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical Cream	SY	c6e4bf5f-f6d6-489e-9286-c30568c601b7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-298-17	68462029817	15 g in 1 TUBE (68462-298-17)	15 g	2015-11-06	0000-00-00	No	No	Current
68462-298-55	68462029855	45 g in 1 TUBE (68462-298-55)	45 g	2015-11-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clotrimazole and Betamethasone Dipropionate	Direct Rx	2025-01-17	HUMAN PRESCRIPTION DRUG LABEL	2
Clotrimazole and Betamethasone Dipropionate	Redpharm Drug	2024-10-04	HUMAN PRESCRIPTION DRUG LABEL	1
Clotrimazole and Betamethasone Dipropionate	NuCare Pharmaceuticals,Inc. \| NuCare Pharamaceuticals,Inc.	2024-06-04	HUMAN PRESCRIPTION DRUG LABEL	5
Clotrimazole and Betamethasone Dipropionate	Preferred Pharmaceuticals Inc.	2024-04-05	HUMAN PRESCRIPTION DRUG LABEL	7
Clotrimazole and Betamethasone Dipropionate	REMEDYREPACK INC.	2024-02-28	HUMAN PRESCRIPTION DRUG LABEL	6
Clotrimazole and Betamethasone Dipropionate	Lake Erie Medical DBA Quality Care Products LLC	2022-02-21	HUMAN PRESCRIPTION DRUG LABEL	4
Clotrimazole and Betamethasone Dipropionate	RPK Pharmaceuticals, Inc.	2021-05-05	HUMAN PRESCRIPTION DRUG LABEL	6
Clotrimazole and Betamethasone Dipropionate	NuCare Pharmaceuticals,Inc.	2021-02-16	HUMAN PRESCRIPTION DRUG LABEL	4
Clotrimazole and Betamethasone Dipropionate	Proficient Rx LP	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL	1
Clotrimazole and Betamethasone Dipropionate	Glenmark Pharmaceuticals Inc. USA \| Glenmark Pharmaceuticals Limited	2020-11-09	HUMAN PRESCRIPTION DRUG LABEL	5
Clotrimazole and Betamethasone Dipropionate	A-S Medication Solutions	2018-01-23	HUMAN PRESCRIPTION DRUG LABEL	3
Clotrimazole and Betamethasone Dipropionate	A-S Medication Solutions	2018-01-23	HUMAN PRESCRIPTION DRUG LABEL	3