Clindamycin Phosphate

Product NDC: 53002-8371
Requested package NDC: 53002-8371-1
11-digit product format: 530028371
Labeler code: 53002
Product ID: 53002-8371_37655ff1-ab83-4ad8-9fd1-e9da45f7d8cc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clindamycin Phosphate
Dosage form: SOLUTION
Route: TOPICAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA208767
Marketing category: ANDA
Marketing start: 2020-06-15
Marketing end: 0000-00-00
Substance: CLINDAMYCIN PHOSPHATE
Active strength: 10 mg/mL
Pharmacologic classes: Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	53002-8371	53002-8371-1	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 · 9 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…`

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
A208767-001	CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT		2018-07-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208767-001	AT

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	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A208767-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208767-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208767-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208767-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208767-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208767-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208767-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208767-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208767-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208767-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208767-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208767-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208767-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208767-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208767-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208767-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208767-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208767-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208767-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208767-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208767-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208767-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208767-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208767-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208767-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208767-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208767-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208767-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208767-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208767-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208767-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208767-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208767-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208767-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208767-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208767-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208767-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208767-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208767-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208767-001	AT	1	`e64feba35796…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Preferred Pharmaceuticals Inc	e06d419f-4b60-405b-9459-e01bbb8d151d	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208767 application number: ANDA208767
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Viona Pharmaceuticals Inc	585e8b72-b350-451f-a232-199b1a01e8ce	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208767 application number: ANDA208767
Clindamycin phosphate	CLINDAMYCIN PHOSPHATE	Zydus Lifesciences Limited	f1f7fb55-1676-4b9e-9f2f-9eaaf33a7633	2024-08-14		Exact identifier application applno (ANDA): 208767 application number: ANDA208767

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-8371-1	53002837101	1 BOTTLE, WITH APPLICATOR in 1 CARTON (53002-8371-1) > 30 mL in 1 BOTTLE, WITH APPLICATOR	2022-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clindamycin Phosphate Topical Solution USP, 1%	RPK Pharmaceuticals, Inc.	2024-12-19	HUMAN PRESCRIPTION DRUG LABEL	4