Clindamycin Phosphate

Product NDC: 68788-8423
11-digit product format: 687888423
Labeler code: 68788
Product ID: 68788-8423_52b5216c-5a85-4eb5-949c-4793fdfe198c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clindamycin Phosphate 1%
Dosage form: GEL
Route: TOPICAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA212438
Marketing category: ANDA
Marketing start: 2023-04-13
Substance: CLINDAMYCIN PHOSPHATE
Active strength: 10 mg/g
Pharmacologic classes: Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-8423-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-8423-6	`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
A212438-001	CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1		2021-03-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212438-001	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.

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	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB	2021-03-11	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212438-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-03-11	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212438-001	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212438-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212438-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212438-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212438-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212438-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212438-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212438-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212438-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212438-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212438-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212438-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212438-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212438-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212438-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212438-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212438-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212438-001	AB1	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212438-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212438-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212438-001	AB	1	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212438-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212438-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212438-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212438-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212438-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212438-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212438-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212438-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212438-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212438-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212438-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212438-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212438-001	AB1	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212438-001	AB1	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Clindamycin Phosphate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLINDAMYCIN PHOSPHATE	10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
EH6D7113I8	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2676585	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
ea8d75ef-0e9b-4177-99f7-c901eb44f888	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68788-8423-6	Clindamycin Phosphate	1 in 1 CARTON	GEL	1		3
68788-8423-6	Clindamycin Phosphate	60 g in 1 TUBE	GEL	60		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8423-6	GM - Gram	68788-8423	d01cd510-27a3-4c1a-82da-706fc938248e	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8423	CLINDAMYCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE 1%) GEL [PREFERRED PHARMACEUTICALS INC.]	2	Current NDC, 2 package rows	20250130_ea8d75ef-0e9b-4177-99f7-c901eb44f888.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE 1%	Preferred Pharmaceuticals Inc.	ea8d75ef-0e9b-4177-99f7-c901eb44f888	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212438 application number: ANDA212438 ndc (product): 68788-8423
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE GEL USP, 1%	Encube Ethicals, Inc.	ac21d7ad-f94e-4d57-95e3-1648add7ad0b	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212438 application number: ANDA212438
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE USP, 1%	A-S Medication Solutions	193a4b02-910f-46b2-8b61-25efea694720	2026-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212438 application number: ANDA212438

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	ea8d75ef-0e9b-4177-99f7-c901eb44f888	3
2676585	Twice-Daily clindamycin 0.01 MG/MG Topical Gel	SCD	ea8d75ef-0e9b-4177-99f7-c901eb44f888	3
2676585	clindamycin (as clindamycin phosphate) 1 % Twice-Daily Topical Gel	SY	ea8d75ef-0e9b-4177-99f7-c901eb44f888	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-8423-6	68788842306	1 TUBE in 1 CARTON (68788-8423-6) / 60 g in 1 TUBE	1 tube	2023-04-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clindamycin Phosphate Gel USP, 1% For External Use	Preferred Pharmaceuticals Inc.	2026-03-30	HUMAN PRESCRIPTION DRUG LABEL	3