Clindamycin Phosphate

Product NDC: 71335-2863
11-digit product format: 713352863
Labeler code: 71335
Product ID: 71335-2863_a783d18c-b4d5-43c8-ba89-eb6f5bb40457
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clindamycin Phosphate
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Bryant Ranch Prepack
Application: ANDA064050
Marketing category: ANDA
Marketing start: 2013-09-17
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: 2026-12-31
Current FDA listing: Yes

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
A064050-001	CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A064050-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT		1995-11-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT		1995-11-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT		1995-11-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT		1995-11-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT		1995-11-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT		1995-11-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`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	A064050-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064050-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064050-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064050-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064050-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064050-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064050-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064050-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064050-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064050-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064050-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064050-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064050-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064050-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064050-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064050-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064050-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064050-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064050-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064050-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064050-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064050-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064050-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064050-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064050-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064050-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064050-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064050-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064050-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064050-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064050-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064050-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064050-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064050-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064050-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064050-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064050-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064050-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064050-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064050-001	AT	1	`e64feba35796…`

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/mL

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
309333	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
25706fd8-d5e2-488b-9888-ee76d2686e19	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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
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
71335-2863-1	Clindamycin Phosphate	60 mL in 1 BOTTLE, WITH APPLICATOR	SOLUTION	60		100
71335-2863-1	Clindamycin Phosphate	1 in 1 CARTON	SOLUTION	1		100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-2863-1	ML - Milliliter	71335-2863	0f4a3d27-d617-4424-bfa5-07da4a8f844d	1	2026-01-08

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	25706fd8-d5e2-488b-9888-ee76d2686e19	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064050 application number: ANDA064050 ndc (product): 71335-2863
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	576fbdf8-b44d-49bf-a569-601861cc402d	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064050 application number: ANDA064050
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	27747e01-85eb-44de-a4a6-711a7799218a	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064050 application number: ANDA064050
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Padagis Israel Pharmaceuticals Ltd	461ab478-3cf6-4e9b-ba7d-0331b379cacf	2026-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064050 application number: ANDA064050
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	c22fb382-afbc-4b2d-bdce-e97e21bddb23	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064050 application number: ANDA064050
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	34f7a271-c012-6463-e063-6394a90ad1ea	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064050 application number: ANDA064050
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	A-S Medication Solutions	ba3f54e5-1ff5-4ffd-8ed2-f15439f423e9	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064050 application number: ANDA064050

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
309333	clindamycin phosphate 1 % Topical Solution	PSN	25706fd8-d5e2-488b-9888-ee76d2686e19	100
309333	clindamycin 10 MG/ML Topical Solution	SCD	25706fd8-d5e2-488b-9888-ee76d2686e19	100
309333	clindamycin (as clindamycin phosphate) 1 % Topical Solution	SY	25706fd8-d5e2-488b-9888-ee76d2686e19	100
309333	clindamycin 1 % Topical Solution	SY	25706fd8-d5e2-488b-9888-ee76d2686e19	100

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-2863-1	71335286301	1 BOTTLE, WITH APPLICATOR in 1 CARTON (71335-2863-1) / 60 mL in 1 BOTTLE, WITH APPLICATOR	2025-10-24	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clindamycin Phosphate Topical Solution USP, 1%	Bryant Ranch Prepack	2026-06-12	HUMAN PRESCRIPTION DRUG LABEL	101