Clindamycin hydrochloride

Product NDC: 68788-8219
11-digit product format: 687888219
Labeler code: 68788
Product ID: 68788-8219_f3cd2be6-a954-4abb-8cad-9962dc0f9430
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clindamycin hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA065061
Marketing category: ANDA
Marketing start: 2022-09-09
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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-8219		D	Discontinued by firm	2026-10-16
excluded package	package	68788-8219	68788-8219-1	D	Discontinued by firm	2026-10-16
excluded package	package	68788-8219	68788-8219-2	D	Discontinued by firm	2026-10-16
excluded package	package	68788-8219	68788-8219-3	D	Discontinued by firm	2026-10-16
excluded package	package	68788-8219	68788-8219-4	D	Discontinued by firm	2026-10-16
excluded package	package	68788-8219	68788-8219-5	D	Discontinued by firm	2026-10-16
excluded package	package	68788-8219	68788-8219-6	D	Discontinued by firm	2026-10-16
excluded package	package	68788-8219	68788-8219-8	D	Discontinued by firm	2026-10-16

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 88 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
2026-10-15 13:18:30	2026-09	A065061-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2001-02-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A065061-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2001-02-02	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A065061-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2001-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065061-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2001-02-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065061-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2001-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065061-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2001-02-02	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A065061-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A065061-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A065061-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065061-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065061-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065061-002	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8219-1	EA - Each	68788-8219	8c857f79-85ec-4d9d-b8bf-ff6b78c070d4	1	2022-09-12
68788-8219-2	EA - Each	68788-8219	749c6de0-7f87-4d64-aeba-1bf0a1fca4fd	1	2022-09-12
68788-8219-3	EA - Each	68788-8219	323afbd3-bc9f-4aba-88f6-aa111335013f	1	2022-09-12
68788-8219-4	EA - Each	68788-8219	2c1ee860-d865-4186-945b-5149715f3be8	1	2022-09-12
68788-8219-5	EA - Each	68788-8219	fb2e65fb-38ed-4350-bb1d-6f932fa3c349	1	2022-09-12
68788-8219-6	EA - Each	68788-8219	39ad0f59-812b-4352-a7aa-fcfb61d2b42c	1	2022-09-12
68788-8219-8	EA - Each	68788-8219	f0062b22-8dd8-4cdb-bcd8-1ce7afd45ad9	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8219	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]	4	Legacy NDC	20250306_f3cd2be6-a954-4abb-8cad-9962dc0f9430.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 2 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	Proficient Rx LP	158e6c0c-1ca3-49a6-84fd-54d8fde7c2a7	2022-06-01	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	Marketing end	Sample	Exclude flag	Status
68788-8219-1	68788821901	14 CAPSULE in 1 BOTTLE (68788-8219-1)	14 capsule	2022-09-09	0000-00-00	No	No	Current
68788-8219-2	68788821902	20 CAPSULE in 1 BOTTLE (68788-8219-2)	20 capsule	2022-09-09	0000-00-00	No	No	Current
68788-8219-3	68788821903	30 CAPSULE in 1 BOTTLE (68788-8219-3)	30 capsule	2022-09-09	0000-00-00	No	No	Current
68788-8219-4	68788821904	40 CAPSULE in 1 BOTTLE (68788-8219-4)	40 capsule	2022-09-09	0000-00-00	No	No	Current
68788-8219-5	68788821905	56 CAPSULE in 1 BOTTLE (68788-8219-5)	56 capsule	2022-09-09	0000-00-00	No	No	Current
68788-8219-6	68788821906	60 CAPSULE in 1 BOTTLE (68788-8219-6)	60 capsule	2022-09-09	0000-00-00	No	No	Current
68788-8219-8	68788821908	21 CAPSULE in 1 BOTTLE (68788-8219-8)	21 capsule	2022-09-09	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.	2025-03-04	HUMAN PRESCRIPTION DRUG LABEL	4