Clindamycin Hydrochloride

Product NDC: 63187-556
Requested package NDC: 63187-556-28
11-digit product format: 631870556
Labeler code: 63187
Product ID: 63187-556_7b78e74c-e7c3-4450-8b78-bc25fcc76b8c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clindamycin Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA063083
Marketing category: ANDA
Marketing start: 2003-03-18
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	63187-556	63187-556-28	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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-556	63187-556-28	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-556	63187-556-28	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A063083-001	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL			1991-07-31
A063083-002	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL			2003-03-18

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	A063083-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		1991-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A063083-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2003-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063083-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		1991-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063083-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2003-03-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A063083-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		1991-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A063083-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2003-03-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063083-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		1991-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063083-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2003-03-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063083-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		1991-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063083-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2003-03-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063083-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		1991-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063083-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2003-03-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063083-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		1991-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063083-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2003-03-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063083-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		1991-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063083-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2003-03-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063083-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		1991-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063083-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2003-03-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A063083-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		1991-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A063083-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2003-03-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063083-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		1991-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063083-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2003-03-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063083-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		1991-07-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063083-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2003-03-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063083-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		1991-07-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063083-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2003-03-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A063083-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		1991-07-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A063083-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2003-03-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063083-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	1991-07-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063083-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2003-03-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A063083-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	1991-07-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A063083-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2003-03-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A063083-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	1991-07-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A063083-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2003-03-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A063083-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	1991-07-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A063083-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2003-03-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A063083-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	1991-07-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A063083-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2003-03-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A063083-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	1991-07-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A063083-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2003-03-18	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063083-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063083-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A063083-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A063083-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A063083-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A063083-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A063083-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A063083-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A063083-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A063083-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A063083-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A063083-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A063083-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A063083-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A063083-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A063083-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A063083-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A063083-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A063083-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A063083-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A063083-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A063083-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A063083-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A063083-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A063083-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A063083-002	AB	1	`ea99ee380514…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A063083-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A063083-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A063083-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A063083-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A063083-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A063083-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A063083-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A063083-002	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-556-21	EA - Each	63187-556	407b5fff-280f-4db4-ac17-448df51a425a	1	2016-11-08
63187-556-28	EA - Each	63187-556	6e669ed0-93d8-4c1c-957e-a855c4369936	1	2019-09-05
63187-556-30	EA - Each	63187-556	04ed95a3-30d6-4dca-93ce-3281b2a5400e	1	2018-08-13
63187-556-40	EA - Each	63187-556	5908ce1b-21ae-4a81-ad58-dbb9d8ddf400	1	2019-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLINDAMYCIN HYDROCHLORIDE	ACTIVE INGREDIENT	T20OQ1YN1W	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
CLINDAMYCIN	ACTIVE MOIETY	3U02EL437C	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-556	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	5	Legacy NDC	20200121_34c67764-99c1-4e40-bb1c-472e5f721ec2.zip

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
63187-556-28	63187055628	28 CAPSULE in 1 BOTTLE, PLASTIC (63187-556-28)	28 capsule	2015-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clindamycin Hydrochloride Capsules USP Revised: September 2014 Rx only 184276-2	Proficient Rx LP	2020-01-01	HUMAN PRESCRIPTION DRUG LABEL	5