Clindamycin hydrochloride

Product NDC: 85534-0088
Requested package NDC: 85534-0088-1
11-digit product format: 855340088
Labeler code: 85534
Product ID: 85534-0088_56dce2d7-c4ea-2e79-e063-6394a90af558
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clindamycin hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: HAWAII REPACK, INC.
Application: ANDA065061
Marketing category: ANDA
Marketing start: 2001-03-23
Substance: CLINDAMYCIN HYDROCHLORIDE
Active strength: 300 mg/1
Pharmacologic classes: Decreased Sebaceous Gland Activity [PE]; Lincosamide Antibacterial [EPC]; Lincosamides [CS]; Neuromuscular Blockade [PE]
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065061-001	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB		2001-02-02
A065061-002	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB		2001-02-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A065061-001	AB
A065061-002	AB

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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A065061-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2001-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065061-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2001-02-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065061-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2001-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065061-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2001-02-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065061-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2001-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065061-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2001-02-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065061-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2001-02-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065061-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2001-02-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065061-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2001-02-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065061-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2001-02-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065061-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2001-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065061-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2001-02-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065061-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2001-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065061-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2001-02-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065061-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2001-02-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065061-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2001-02-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065061-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2001-02-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065061-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2001-02-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065061-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2001-02-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065061-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2001-02-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065061-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2001-02-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065061-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2001-02-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065061-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2001-02-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065061-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2001-02-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065061-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2001-02-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065061-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2001-02-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065061-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2001-02-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065061-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2001-02-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065061-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2001-02-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065061-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2001-02-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065061-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2001-02-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065061-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2001-02-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065061-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2001-02-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065061-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2001-02-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065061-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2001-02-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065061-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2001-02-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065061-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2001-02-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065061-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2001-02-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065061-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2001-02-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065061-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2001-02-02	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065061-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065061-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065061-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065061-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065061-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065061-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065061-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065061-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065061-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065061-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065061-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065061-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065061-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065061-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065061-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065061-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065061-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065061-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065061-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065061-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065061-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065061-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065061-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065061-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065061-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065061-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065061-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065061-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065061-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065061-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065061-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065061-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065061-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065061-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065061-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065061-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065061-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065061-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065061-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065061-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLINDAMYCIN HYDROCHLORIDE	300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
T20OQ1YN1W	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197518	Internal RxNorm lookup
284215	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
c6703df0-b41d-439f-8e0d-d30b3039b3f8	Available on FDA.report

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	HAWAII REPACK, INC.	c6703df0-b41d-439f-8e0d-d30b3039b3f8	2026-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061 ndc (package): 85534-0088-1 ndc (product): 85534-0088 ndc11 (package): 85534008801
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	fadc321a-2291-4268-936f-0743fdddbe7f	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Major Pharmaceuticals	f9e6ed50-ad03-4a9e-8760-8733e04a058c	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	1dbd8448-c1e5-46df-8060-50ef82380445	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Unit Dose Solutions, Inc.	535e7e17-d020-4aa6-e063-6294a90ae114	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Golden State Medical Supply, Inc.	a69260bb-31b5-4f77-e053-2995a90a37e1	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	REMEDYREPACK INC.	7f7fc73a-86e1-4d3e-8c83-1c74621e4af4	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Cardinal Health 107, LLC	b22be885-f441-473e-879a-862588dcf89d	2026-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Northwind Health Company, LLC	f781897a-ab54-7373-e053-6294a90a89a3	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	4730ab20-09e2-d32a-e063-6394a90ae125	2025-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	American Health Packaging	3f6b2c5a-e581-414f-bc9e-eaf66a5685cd	2025-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin HCL	CLINDAMYCIN HCL	Advanced Rx of Tennessee, LLC	b43dc396-17ef-a523-e053-2a95a90ac872	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	2b13d66d-4f48-477e-ba32-20e85d0e708d	2024-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	7537fbab-c792-4b77-8736-c24b69cf48ea	2024-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	678912ff-a0c1-171b-e053-2991aa0ad128	2024-06-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	63f26644-b7ab-98c1-e053-2a91aa0af5d3	2024-06-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	A-S Medication Solutions	337870c6-11e0-4d1a-a26e-afe042ee08c3	2024-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	A-S Medication Solutions	600c5ac7-64f7-44ac-9e83-cc1036471eec	2023-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	A-S Medication Solutions	22bf9385-cad3-43a7-802f-131b6826b5a5	2023-09-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Asclemed USA, Inc.	cd5a1db8-9ddf-4de3-b856-bc3e8fb29061	2023-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
T20OQ1YN1W	CLINDAMYCIN HYDROCHLORIDE	21462-39-5	CLINDAMYCIN HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Status
85534-0088-1	85534008801	12 CAPSULE in 1 BOTTLE (85534-0088-1)	12 capsule	2026-07-18	0	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP Rx only	HAWAII REPACK, INC.	2026-07-18	HUMAN PRESCRIPTION DRUG LABEL	1