Clindesse

Product NDC: 64011-124
11-digit product format: 640110124
Labeler code: 64011
Product ID: 64011-124_a96a8d64-4abd-4ef0-a2db-558d973c4029
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clindamycin phosphate
Dosage form: CREAM
Route: VAGINAL
Labeler: Ther-Rx Corporation
Application: NDA050793
Marketing category: NDA
Marketing start: 2009-11-01
Marketing end: 0000-00-00
Substance: CLINDAMYCIN PHOSPHATE
Active strength: 20 mg/g
Pharmacologic classes: Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]
NDC exclude flag: No
Listing certified through: 2019-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	64011-124		D	Discontinued by firm	2026-08-17
excluded package	package	64011-124	64011-124-08	D	Discontinued by firm	2026-08-17
excluded package	package	64011-124	64011-124-27	D	Discontinued by firm	2026-08-17

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 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64011-124-27	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64011-124-08	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64011-124-27	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64011-124-08	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64011-124-27	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64011-124-08	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64011-124-27	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64011-124-08	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64011-124-27	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64011-124-08	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64011-124-27	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64011-124-08	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64011-124-27	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64011-124-08	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64011-124-27	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64011-124-08	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64011-124-27	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64011-124-08	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64011-124-27	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64011-124-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64011-124-27	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64011-124-08	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64011-124-27	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64011-124-08	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	64011-124-08	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	64011-124-27	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	64011-124-08	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	64011-124-27	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050793-001	CLINDESSE	CLINDAMYCIN PHOSPHATE	EQ 2% BASE	CREAM / VAGINAL		RLD, RS	2004-11-30

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050793-001	6899890	2023-04-27	U-137	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050793-001	6899890	2023-04-27	U-137	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050793-001	6899890	2023-04-27	U-137	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050793-001	6899890	2023-04-27	U-137	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050793-001	6899890	2023-04-27	U-137	Drug product		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050793-001	6899890	2023-04-27	U-137	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050793-001	6899890	2023-04-27	U-137	Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050793-001	6899890	2023-04-27	U-137	Drug product		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050793-001	6899890	2023-04-27	U-137	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050793-001	6899890	2023-04-27	U-137	Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050793-001	6899890	2023-04-27	U-137	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050793-001	6899890	2023-04-27	U-137	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050793-001	6899890	2023-04-27	U-137	Drug product		`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
64011-124-08	2021-12-01	These highlights do not include all the information needed to use Clindesse safely and effectively. See full prescribing information for Clindesse. Clindesse ® (clindamycin phosphate) Vaginal Cream, 2% For intravaginal use only. Initial U.S. Approval: 1972
64011-124-27	2021-12-01	These highlights do not include all the information needed to use Clindesse safely and effectively. See full prescribing information for Clindesse. Clindesse ® (clindamycin phosphate) Vaginal Cream, 2% For intravaginal use only. Initial U.S. Approval: 1972
64011-124-08	2020-01-31	These highlights do not include all the information needed to use Clindesse safely and effectively. See full prescribing information for Clindesse. Clindesse ® (clindamycin phosphate) Vaginal Cream, 2% For intravaginal use only. Initial U.S. Approval: 1972
64011-124-27	2020-01-31	These highlights do not include all the information needed to use Clindesse safely and effectively. See full prescribing information for Clindesse. Clindesse ® (clindamycin phosphate) Vaginal Cream, 2% For intravaginal use only. Initial U.S. Approval: 1972

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64011-124-08	GM - Gram	64011-124	1ef7134c-ac54-48f8-aa0b-a020fdeaad91	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLINDAMYCIN PHOSPHATE	ACTIVE INGREDIENT	EH6D7113I8	CLINDESSE (CLINDAMYCIN PHOSPHATE) CREAM [THER-RX CORPORATION]	10
CLINDAMYCIN	ACTIVE MOIETY	3U02EL437C	CLINDESSE (CLINDAMYCIN PHOSPHATE) CREAM [THER-RX CORPORATION]	10
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	CLINDESSE (CLINDAMYCIN PHOSPHATE) CREAM [THER-RX CORPORATION]	10
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	CLINDESSE (CLINDAMYCIN PHOSPHATE) CREAM [THER-RX CORPORATION]	10
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	CLINDESSE (CLINDAMYCIN PHOSPHATE) CREAM [THER-RX CORPORATION]	10
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	CLINDESSE (CLINDAMYCIN PHOSPHATE) CREAM [THER-RX CORPORATION]	10
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	CLINDESSE (CLINDAMYCIN PHOSPHATE) CREAM [THER-RX CORPORATION]	10
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	CLINDESSE (CLINDAMYCIN PHOSPHATE) CREAM [THER-RX CORPORATION]	10
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CLINDESSE (CLINDAMYCIN PHOSPHATE) CREAM [THER-RX CORPORATION]	10
SORBITOL	INACTIVE INGREDIENT	506T60A25R	CLINDESSE (CLINDAMYCIN PHOSPHATE) CREAM [THER-RX CORPORATION]	10
WATER	INACTIVE INGREDIENT	059QF0KO0R	CLINDESSE (CLINDAMYCIN PHOSPHATE) CREAM [THER-RX CORPORATION]	10
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	CLINDESSE (CLINDAMYCIN PHOSPHATE) CREAM [THER-RX CORPORATION]	10

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clindesse	CLINDAMYCIN PHOSPHATE	Padagis Israel Pharmaceuticals Ltd	fe8bb204-f173-44fe-803b-b08f2ec5aa31	2025-01-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050793 application number: NDA050793

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EH6D7113I8	CLINDAMYCIN PHOSPHATE	24729-96-2	CLINDAMYCIN PHOSPHATE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clindesse	Ther-Rx Corporation \| KV Pharmaceutical Co. \| Perrigo Israel Pharmaceuticals Ltd.	2013-04-12	HUMAN PRESCRIPTION DRUG LABEL	10