Clindamycin Hydrochloride

Product NDC: 65862-185
11-digit product format: 658620185
Labeler code: 65862
Product ID: 65862-185_97a9034b-2c9f-48a0-95a0-62e60c49329c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clindamycin Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA065442
Marketing category: ANDA
Marketing start: 2009-08-26
Substance: CLINDAMYCIN HYDROCHLORIDE
Active strength: 150 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

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
unfinished product	product	65862-185		UNFINISHED	Active or certified unfinished drug listing	2026-08-03
unfinished package	package	65862-185	65862-185-22	UNFINISHED	Active or certified unfinished drug listing	2026-08-03
unfinished package	package	65862-185	65862-185-40	UNFINISHED	Active or certified unfinished drug listing	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 · 40 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	65862-185-22	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	65862-185-22	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	65862-185-22	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	65862-185-22	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	65862-185-22	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	65862-185-22	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	65862-185-22	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	65862-185-22	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	65862-185-22	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	65862-185-22	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	65862-185-22	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	65862-185-22	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	65862-185-22	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	65862-185-22	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	65862-185-22	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	65862-185-22	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	65862-185-22	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	65862-185-22	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	65862-185-22	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	65862-185-22	`263afe128892…`	`91768de4ddbe…`

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…`

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	150 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
2367340c-d297-4a3f-8253-6d27a0ed39cb	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
65862-185-01	Clindamycin Hydrochloride	100 in 1 BOTTLE	CAPSULE	100		22
65862-185-05	Clindamycin Hydrochloride	500 in 1 BOTTLE	CAPSULE	500		22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-185-01	EA - Each	65862-185	49862960-e331-4baa-8bae-c4882f2ec3c9	1	2012-07-24
65862-185-05	EA - Each	65862-185	aca80404-6b6a-49a8-b0d6-f28de0a1b8e5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLINDAMYCIN HYDROCHLORIDE	ACTIVE INGREDIENT	T20OQ1YN1W	CLINDAMYCIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	7
CLINDAMYCIN	ACTIVE MOIETY	3U02EL437C	CLINDAMYCIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	7
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CLINDAMYCIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	7
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CLINDAMYCIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	7
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CLINDAMYCIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	7
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CLINDAMYCIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLINDAMYCIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLINDAMYCIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	7
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CLINDAMYCIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	7
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CLINDAMYCIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLINDAMYCIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	7
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CLINDAMYCIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CLINDAMYCIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	7
CLINDAMYCIN HYDROCHLORIDE	ACTIVE INGREDIENT	T20OQ1YN1W	CLINDAMYCIN HYDROCHLORIDE CAPSULE [AVPAK]	2
CLINDAMYCIN	ACTIVE MOIETY	3U02EL437C	CLINDAMYCIN HYDROCHLORIDE CAPSULE [AVPAK]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CLINDAMYCIN HYDROCHLORIDE CAPSULE [AVPAK]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CLINDAMYCIN HYDROCHLORIDE CAPSULE [AVPAK]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CLINDAMYCIN HYDROCHLORIDE CAPSULE [AVPAK]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CLINDAMYCIN HYDROCHLORIDE CAPSULE [AVPAK]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLINDAMYCIN HYDROCHLORIDE CAPSULE [AVPAK]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLINDAMYCIN HYDROCHLORIDE CAPSULE [AVPAK]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CLINDAMYCIN HYDROCHLORIDE CAPSULE [AVPAK]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CLINDAMYCIN HYDROCHLORIDE CAPSULE [AVPAK]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLINDAMYCIN HYDROCHLORIDE CAPSULE [AVPAK]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CLINDAMYCIN HYDROCHLORIDE CAPSULE [AVPAK]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CLINDAMYCIN HYDROCHLORIDE CAPSULE [AVPAK]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-185	CLINDAMYCIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	20	Current NDC, Legacy NDC, 2 package rows	20240913_2367340c-d297-4a3f-8253-6d27a0ed39cb.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 · 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 ndc (product): 65862-185
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197518	clindamycin HCl 150 MG Oral Capsule	PSN	2367340c-d297-4a3f-8253-6d27a0ed39cb	22
284215	clindamycin HCl 300 MG Oral Capsule	PSN	2367340c-d297-4a3f-8253-6d27a0ed39cb	22
197518	clindamycin 150 MG Oral Capsule	SCD	2367340c-d297-4a3f-8253-6d27a0ed39cb	22
284215	clindamycin 300 MG Oral Capsule	SCD	2367340c-d297-4a3f-8253-6d27a0ed39cb	22
197518	clindamycin (as clindamycin HCl) 150 MG Oral Capsule	SY	2367340c-d297-4a3f-8253-6d27a0ed39cb	22
284215	clindamycin (as clindamycin HCl) 300 MG Oral Capsule	SY	2367340c-d297-4a3f-8253-6d27a0ed39cb	22
197518	clindamycin HCl 150 MG Oral Capsule	PSN	8af1493c-1f22-4629-a432-f8b0578189e1	9
197518	clindamycin 150 MG Oral Capsule	SCD	8af1493c-1f22-4629-a432-f8b0578189e1	9
197518	clindamycin (as clindamycin HCl) 150 MG Oral Capsule	SY	8af1493c-1f22-4629-a432-f8b0578189e1	9
197518	clindamycin HCl 150 MG Oral Capsule	PSN	50d70f26-662a-1ea2-e054-00144ff88e88	3
197518	clindamycin 150 MG Oral Capsule	SCD	50d70f26-662a-1ea2-e054-00144ff88e88	3
197518	clindamycin (as clindamycin HCl) 150 MG Oral Capsule	SY	50d70f26-662a-1ea2-e054-00144ff88e88	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-185-01	65862018501	100 CAPSULE in 1 BOTTLE (65862-185-01)	100 capsule	2009-08-26	0000-00-00	No	No	Current
65862-185-05	65862018505	500 CAPSULE in 1 BOTTLE (65862-185-05)	500 capsule	2009-08-26	0000-00-00	No	No	Current
65862-185-22	65862018522	2000 CAPSULE in 1 BAG (65862-185-22)	2000 capsule	26-AUG-09				Current
65862-185-40	65862018540	40000 CAPSULE in 1 BAG (65862-185-40)	40000 capsule	27-FEB-25				Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clindamycin Hydrochloride Capsules, USP Rx only	Aurobindo Pharma Limited \| Aurovitas Pharma Taizhou Co.,LTD	2026-04-01	Human Prescription Drug Label	22
Clindamycin Hydrochloride Capsules, USP Rx only	A-S Medication Solutions	2024-09-04	Human Prescription Drug Label	9
Clindamycin Hydrochloride - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2024-08-08	HUMAN PRESCRIPTION DRUG LABEL	3
Clindamycin Hydrochloride Capsules, USP Rx only	Mylan Institutional Inc.	2019-12-30	HUMAN PRESCRIPTION DRUG LABEL	6
Clindamycin Hydrochloride - Aurobindo Pharma Limited	Aurobindo Pharma Limited	2019-11-06	Human Prescription Drug Label	4
Clindamycin Hydrochloride Capsules, USP	AvPAK	2018-02-14	HUMAN PRESCRIPTION DRUG LABEL	4