Clindamycin Hydrochloride

Product NDC: 60760-693
Requested package NDC: 60760-693-16
11-digit product format: 607600693
Labeler code: 60760
Product ID: 60760-693_9c56afa2-bffa-fa03-e053-2995a90a7437
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clindamycin Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: St Mary's Medical Park Pharmacy
Application: ANDA065243
Marketing category: ANDA
Marketing start: 2019-09-03
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]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	60760-693	60760-693-16	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 · 12 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…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A065243-001	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12
A065243-002	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12
A065243-003	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065243-002	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 4 · 123 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	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065243-002	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-08-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065243-003	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2005-08-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065243-001	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-12	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 53 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	A065243-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065243-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065243-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065243-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065243-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065243-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065243-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065243-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065243-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065243-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065243-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065243-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065243-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065243-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065243-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065243-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065243-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065243-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065243-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065243-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065243-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065243-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065243-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065243-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065243-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A065243-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A065243-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065243-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A065243-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A065243-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065243-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065243-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065243-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065243-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065243-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065243-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065243-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065243-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065243-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065243-002	AB	1	`6a51e52b5d6a…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60760-693-10	2024-01-30	C162847	48780-1	1030e365-3eaa-111a-e063-dadaa90a10e2	Clindamycin HCl Capsules, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60760-693-05	EA - Each	60760-693	2fb346e5-c6a4-4786-b3f9-21a676154f52	1	2017-06-15
60760-693-10	EA - Each	60760-693	0f4aa98e-3045-48c1-9bd1-d75edbfd39cf	1	2019-10-07
60760-693-16	EA - Each	60760-693	10221c49-7718-4951-89b7-7e22a50094e9	1	2018-03-08
60760-693-20	EA - Each	60760-693	8bf1c211-8796-4e29-95e2-4dfd499873d1	1	2017-10-13
60760-693-30	EA - Each	60760-693	c20d559f-9b1f-4f78-aebb-e3b2b4ff0d64	1	2017-06-15

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 Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Chartwell RX, LLC	e8167412-882e-4143-93c6-49e68adbcf16	2024-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065243 application number: ANDA065243

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
60760-693-16	60760069316	16 CAPSULE in 1 BOTTLE, PLASTIC (60760-693-16)	16 capsule	2018-02-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clindamycin HCl Capsules, USP	St. Mary's Medical Park Pharmacy	2020-01-22	HUMAN PRESCRIPTION DRUG LABEL	7
Clindamycin HCl Capsules, USP	St Mary's Medical Park Pharmacy \| Lannett Company, Inc. \| St. Mary's Medical Park Pharmacy	2020-01-17	HUMAN PRESCRIPTION DRUG LABEL	2