Clindamycin Hydrochloride

Product NDC: 68788-7639
Requested package NDC: 68788-7639-3
11-digit product format: 687887639
Labeler code: 68788
Product ID: 68788-7639_2494747f-891c-4282-9f11-76b2f95eac06
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clindamycin Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA065442
Marketing category: ANDA
Marketing start: 2020-06-01
Marketing end: 0000-00-00
Substance: CLINDAMYCIN HYDROCHLORIDE
Active strength: 300 mg/1
Pharmacologic classes: Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68788-7639	68788-7639-3	D	Discontinued by firm		2026-08-03

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 · 6 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`

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
A065442-001	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB		2009-08-26
A065442-002	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB		2009-08-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065442-001	AB
A065442-002	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	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`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	A065442-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065442-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065442-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065442-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065442-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065442-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065442-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065442-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065442-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065442-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065442-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065442-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065442-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065442-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065442-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065442-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065442-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065442-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065442-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065442-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065442-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065442-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065442-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065442-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065442-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065442-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065442-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065442-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065442-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065442-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065442-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065442-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065442-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065442-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065442-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065442-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065442-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065442-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065442-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065442-002	AB	1	`782e0a99824c…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Major Pharmaceuticals	d53a66bf-fdbd-4a12-8d8c-4e3ab94e9ef5	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065442 application number: ANDA065442
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Aurobindo Pharma Limited	2367340c-d297-4a3f-8253-6d27a0ed39cb	2026-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065442 application number: ANDA065442
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Northwind Health Company, LLC	f2f08e98-f6c5-7c2d-e053-2995a90abe1e	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065442 application number: ANDA065442
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Redpharm Drug	0a0fbeae-2bc2-2402-e063-6394a90a97a0	2025-12-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065442 application number: ANDA065442
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	VERITYRX, LLC	427a0138-c2dd-cf0b-e063-6394a90af407	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065442 application number: ANDA065442
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	A-S Medication Solutions	9fe68a5a-487b-4119-9ee7-603948d732e4	2025-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065442 application number: ANDA065442
Clindamycin HCL	CLINDAMYCIN HCL	Advanced Rx Pharmacy of Tennessee, LLC	c46cac0a-0c36-02fa-e053-2995a90a772b	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065442 application number: ANDA065442
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	A-S Medication Solutions	8af1493c-1f22-4629-a432-f8b0578189e1	2024-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065442 application number: ANDA065442
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	A-S Medication Solutions	2393251d-33b9-4274-9d04-27ec9968eaa1	2024-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065442 application number: ANDA065442
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Proficient Rx LP	d6e1a5f2-9dcb-49fb-a5b0-d7d543520ac3	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065442 application number: ANDA065442

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	Marketing end	Sample	Exclude flag	Status
68788-7639-3	68788763903	30 CAPSULE in 1 BOTTLE (68788-7639-3)	30 capsule	2020-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clindamycin Hydrochloride Capsules, USP Rx only	Preferred Pharmaceuticals, Inc.	2024-03-28	HUMAN PRESCRIPTION DRUG LABEL	5