Cleocin

Product NDC: 0009-7667
11-digit product format: 000097667
Labeler code: 0009
Product ID: 0009-7667_187697a2-a941-4fe8-9be2-c442d0fd5e07
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clindamycin phosphate
Dosage form: SUPPOSITORY
Route: VAGINAL
Labeler: Pharmacia & Upjohn Company LLC
Application: NDA050767
Marketing category: NDA
Marketing start: 2024-02-03
Substance: CLINDAMYCIN PHOSPHATE
Active strength: 100 mg/1
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

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
N050767-001	CLEOCIN	CLINDAMYCIN PHOSPHATE	100MG	SUPPOSITORY / VAGINAL		RLD, RS	1999-08-13

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050767-001	CLEOCIN	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1999-08-13	`e64feba35796…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N050767-001	6495157	2020-07-20	Drug product	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N050767-001	6495157	2020-07-20	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050767-001	6495157	2020-07-20	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050767-001	6495157	2020-07-20	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050767-001	6495157	2020-07-20	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050767-001	6495157	2020-07-20	Drug product	`ea99ee380514…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLINDAMYCIN PHOSPHATE	100 mg/1

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
259233	Internal RxNorm lookup
882533	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
3db26227-208d-4fdd-8426-1d9be5cda9b4	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
0009-7667-05	Cleocin	3 in 1 BLISTER PACK	SUPPOSITORY	3		32
0009-7667-05	Cleocin	1 in 1 CARTON	SUPPOSITORY	1		32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0009-7667-01	EA - Each	0009-7667	906628ee-4412-4da9-8d7e-383c942d809d	1	2012-07-24
0009-7667-05	EA - Each	0009-7667	4ca43042-bad8-4dbf-b0cc-016f059711c5	1	2024-03-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
CLINDAMYCIN PHOSPHATE	ACTIVE INGREDIENT	EH6D7113I8	CLEOCIN (CLINDAMYCIN PHOSPHATE) SUPPOSITORY [PHARMACIA AND UPJOHN COMPANY]	10
CLINDAMYCIN	ACTIVE MOIETY	3U02EL437C	CLEOCIN (CLINDAMYCIN PHOSPHATE) SUPPOSITORY [PHARMACIA AND UPJOHN COMPANY]	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0009-7667	CLEOCIN (CLINDAMYCIN PHOSPHATE) SUPPOSITORY [PHARMACIA & UPJOHN COMPANY LLC]	30	Current NDC, Legacy NDC, 2 package rows	20250410_3db26227-208d-4fdd-8426-1d9be5cda9b4.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
Cleocin	CLINDAMYCIN PHOSPHATE	Pharmacia & Upjohn Company LLC	3db26227-208d-4fdd-8426-1d9be5cda9b4	2026-03-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050767 application number: NDA050767 ndc (product): 0009-7667

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
882533	Cleocin 100 MG Vaginal Insert	PSN	3db26227-208d-4fdd-8426-1d9be5cda9b4	32
259233	clindamycin phosphate 100 MG Vaginal Insert	PSN	3db26227-208d-4fdd-8426-1d9be5cda9b4	32
882533	clindamycin 100 MG Vaginal Insert [Cleocin]	SBD	3db26227-208d-4fdd-8426-1d9be5cda9b4	32
259233	clindamycin 100 MG Vaginal Insert	SCD	3db26227-208d-4fdd-8426-1d9be5cda9b4	32
882533	Cleocin (as clindamycin phosphate) 100 MG Vaginal Insert	SY	3db26227-208d-4fdd-8426-1d9be5cda9b4	32
882533	Cleocin 100 MG Vaginal Insert	SY	3db26227-208d-4fdd-8426-1d9be5cda9b4	32
259233	clindamycin (as clindamycin phosphate) 100 MG Vaginal Insert	SY	3db26227-208d-4fdd-8426-1d9be5cda9b4	32

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0009-7667-01	00009766701	1 BLISTER PACK in 1 CARTON (0009-7667-01) > 3 SUPPOSITORY in 1 BLISTER PACK	1 blister pack	1999-08-13	0000-00-00	No	No	Current
0009-7667-05	00009766705	1 BLISTER PACK in 1 CARTON (0009-7667-05) / 3 SUPPOSITORY in 1 BLISTER PACK	1 blister pack	2024-02-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cleocin ® Vaginal Ovules (clindamycin phosphate vaginal suppositories)	Pharmacia & Upjohn Company LLC	2026-03-09	HUMAN PRESCRIPTION DRUG LABEL	32