clindamycin phosphate

Product NDC: 50090-0768
Requested package NDC: 50090-0768-0
11-digit product format: 500900768
Labeler code: 50090
Product ID: 50090-0768_6f15a879-eb5d-42c6-a009-de5b4feab887
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clindamycin phosphate
Dosage form: GEL
Route: TOPICAL
Labeler: A-S Medication Solutions
Application: ANDA064160
Marketing category: ANDA
Marketing start: 2000-01-28
Marketing end: 0000-00-00
Substance: CLINDAMYCIN PHOSPHATE
Active strength: 10 mg/g
Pharmacologic classes: Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-0768	50090-0768-0	I	Inactivated by FDA		2026-09-14

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A064160-001	CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1		2000-01-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A064160-001	AB1

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	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2000-01-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2000-01-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2000-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2000-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2000-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2000-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2000-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2000-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2000-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2000-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2000-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2000-01-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2000-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2000-01-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2000-01-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2000-01-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2000-01-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2000-01-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2000-01-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB	2000-01-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2000-01-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2000-01-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB	2000-01-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB	2000-01-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB	2000-01-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB	2000-01-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB	2000-01-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB	2000-01-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB	2000-01-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2000-01-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2000-01-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2000-01-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2000-01-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2000-01-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2000-01-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2000-01-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2000-01-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2000-01-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2000-01-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064160-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2000-01-28	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A064160-001	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A064160-001	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064160-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064160-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064160-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064160-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064160-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064160-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064160-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064160-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064160-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064160-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064160-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064160-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064160-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064160-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064160-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064160-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064160-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064160-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064160-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064160-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064160-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064160-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064160-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064160-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064160-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064160-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064160-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064160-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064160-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064160-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064160-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064160-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064160-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064160-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064160-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064160-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064160-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064160-001	AB1	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a46239a7-5963-4008-8cbb-6b9000f497eb	Product name	1	20250721
1426d8f8-b7d5-4053-8554-613df00c0d86	Product name	2	20250616
b382b4e1-6b48-45f6-bffc-e61b00b0ce19	Product name	3	20250317
d8f81258-db12-0761-46cc-8ff6e62e9302	Product name	4	20240422
b7b2fa42-1c77-d724-81f0-87da60a77e79	Product name	3	20240320
b27c7c65-51f2-a62f-e0e6-a26b3a0f8eb0	Product name	3	20230425
e3af9708-3004-7392-4046-5311eaa8bab5	Product name	3	20221128
ffb4bacf-f636-0f7d-0b0d-7a4b151243e3	Product name	9	20220928
b72227d6-0388-43bd-995b-b762d2754cd5	Product name	1	20220706
a92d22e0-3af4-f301-bc88-27ff030b0070	Product name	2	20220316
4a7d44fe-774d-404b-aad0-8a90fe78375a	Product name	4	20211025
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27b	Product name	3	20200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992	Product name	4	20190619
5ce6ce33-4f2b-3ce0-757d-e520013280cf	Product name	5	20180719
b92a26f1-6926-4817-be73-e26ab4c2146f	Product name	1	20170602
028d6c95-5012-6976-2075-dee0ae6fefe2	Product name	1	20140508
468b2c08-8adb-8d0f-8257-c6515a061424	Product name	1	20140508
8959fb29-d86f-c521-666a-b4cb22233594	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-0768-0	2023-01-30	C162847	48780-1	f386c64a-0556-0266-e053-dadaa90a7c1a	Clindamycin Phosphate Topical Solution USP, 1%, Clindamycin Phosphate Gel USP, 1%, Clindamycin Phosphate Lotion (Clindamycin Phosphate Topical Suspension USP, 1%)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-0768-0	clindamycin phosphate	30 g in 1 TUBE	GEL	30		15
50090-0768-0	clindamycin phosphate	1 in 1 CARTON	GEL	1		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-0768-0	GM - Gram	50090-0768	b9ce7ac8-580a-4ad3-bd00-b1b4532b300b	1	2018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-0768	CLINDAMYCIN PHOSPHATE GEL [A-S MEDICATION SOLUTIONS]	15	Legacy NDC, 2 package rows	20210616_e0a0221d-f1fc-470c-8646-8da33c815b8a.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
clindamycin phosphate	CLINDAMYCIN PHOSPHATE	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	62a2019f-7410-4251-95ed-181925ade6e4	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064160 application number: ANDA064160

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2676585	clindamycin phosphate 1 % Twice-Daily Topical Gel	PSN	e0a0221d-f1fc-470c-8646-8da33c815b8a	15
2676585	Twice-Daily clindamycin 0.01 MG/MG Topical Gel	SCD	e0a0221d-f1fc-470c-8646-8da33c815b8a	15
2676585	clindamycin (as clindamycin phosphate) 1 % Twice-Daily Topical Gel	SY	e0a0221d-f1fc-470c-8646-8da33c815b8a	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-0768-0	50090076800	1 TUBE in 1 CARTON (50090-0768-0) > 30 g in 1 TUBE	1 tube	2014-11-28	0000-00-00	No	No	Current