Clindamycin Phosphate

Product NDC: 69238-2031
11-digit product format: 692382031
Labeler code: 69238
Product ID: 69238-2031_e3ac80f9-e1cc-4e37-bc97-f3ee4cd928e4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clindamycin Phosphate
Dosage form: GEL
Route: TOPICAL
Labeler: Amneal Pharmaceuticals NY LLC
Application: ANDA214668
Marketing category: ANDA
Marketing start: 2022-08-08
Substance: CLINDAMYCIN PHOSPHATE
Active strength: 1 g/100mL
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

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product	69238-2031		E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69238-2031	69238-2031-7	E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`

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
A214668-001	CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB2		2022-08-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214668-001	AB2

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	A214668-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB2	2022-08-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214668-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB2	2022-08-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214668-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB2	2022-08-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214668-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB2	2022-08-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214668-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB2	2022-08-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214668-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB2	2022-08-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214668-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB2	2022-08-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214668-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB2	2022-08-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214668-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB2	2022-08-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214668-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB2	2022-08-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214668-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB2	2022-08-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214668-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB2	2022-08-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214668-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB2	2022-08-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214668-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB2	2022-08-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214668-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB2	2022-08-05	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214668-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB2	2022-08-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214668-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB2	2022-08-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214668-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB2	2022-08-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214668-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB2	2022-08-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214668-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB2	2022-08-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214668-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB2	2022-08-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214668-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB2	2022-08-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214668-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB2	2022-08-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214668-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB2	2022-08-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214668-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB2	2022-08-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214668-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB2	2022-08-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214668-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB2	2022-08-05	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214668-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB2	2022-08-05	`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	A214668-001	AB2	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214668-001	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214668-001	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214668-001	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214668-001	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214668-001	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214668-001	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214668-001	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214668-001	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214668-001	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214668-001	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214668-001	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214668-001	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214668-001	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214668-001	AB2	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214668-001	AB2	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214668-001	AB2	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214668-001	AB2	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214668-001	AB2	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214668-001	AB2	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214668-001	AB2	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214668-001	AB2	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214668-001	AB2	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214668-001	AB2	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214668-001	AB2	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214668-001	AB2	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214668-001	AB2	1	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214668-001	AB2	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2023-12-20 04:57 UTC	2023-12	A214668-001	CGT	2023-02-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214668-001	CGT	2023-02-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214668-001	CGT	2023-02-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214668-001	CGT	2023-02-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214668-001	CGT	2023-02-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214668-001	CGT	2023-02-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214668-001	CGT	2023-02-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214668-001	CGT	2023-02-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214668-001	CGT	2023-02-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214668-001	CGT	2023-02-01	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Clindamycin Phosphate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLINDAMYCIN PHOSPHATE	1 g/100mL

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
309332	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
ea1d4a37-7da2-4228-8451-6367e1a62554	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
69238-2031-7	Clindamycin Phosphate	75 mL in 1 BOTTLE	GEL	75		8
69238-2031-7	Clindamycin Phosphate	1 in 1 CARTON	GEL	1		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69238-2031-7	ML - Milliliter	69238-2031	227b0b55-1e09-4fab-bd45-f320179579d0	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69238-2031	CLINDAMYCIN PHOSPHATE GEL [AMNEAL PHARMACEUTICALS NY LLC]	8	Current NDC, Legacy NDC, 2 package rows	20240606_ea1d4a37-7da2-4228-8451-6367e1a62554.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	Amneal Pharmaceuticals NY LLC	ea1d4a37-7da2-4228-8451-6367e1a62554	2024-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214668 application number: ANDA214668 ndc (product): 69238-2031

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
309332	clindamycin phosphate 1 % Once-Daily Topical Gel	PSN	ea1d4a37-7da2-4228-8451-6367e1a62554	8
309332	Once-Daily clindamycin 0.01 MG/MG Topical Gel	SCD	ea1d4a37-7da2-4228-8451-6367e1a62554	8
309332	clindamycin (as clindamycin phosphate) 1 % Once-Daily Topical Gel	SY	ea1d4a37-7da2-4228-8451-6367e1a62554	8
309332	clindamycin 1 % Once-Daily Topical Gel	SY	ea1d4a37-7da2-4228-8451-6367e1a62554	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69238-2031-7	69238203107	1 BOTTLE in 1 CARTON (69238-2031-7) / 75 mL in 1 BOTTLE	1 bottle	2022-08-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clindamycin Phosphate Gel USP, 1% For External Use	Amneal Pharmaceuticals NY LLC \| Amneal Pharmaceuticals, LLC	2024-05-29	HUMAN PRESCRIPTION DRUG LABEL	8