Clindamycin Hydrochloride

Product NDC: 63187-381
11-digit product format: 631870381
Labeler code: 63187
Product ID: 63187-381_b2a38220-ee12-47b9-941e-c6f12545bb68
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clindamycin Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA063029
Marketing category: ANDA
Marketing start: 2016-03-14
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: 2022-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63187-381		D	Discontinued by firm	2026-10-16
excluded package	package	63187-381	63187-381-20	D	Discontinued by firm	2026-10-16
excluded package	package	63187-381	63187-381-21	D	Discontinued by firm	2026-10-16
excluded package	package	63187-381	63187-381-28	D	Discontinued by firm	2026-10-16
excluded package	package	63187-381	63187-381-30	D	Discontinued by firm	2026-10-16
excluded package	package	63187-381	63187-381-40	D	Discontinued by firm	2026-10-16
excluded package	package	63187-381	63187-381-60	D	Discontinued by firm	2026-10-16

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 · 14 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 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-381-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-381-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-381-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-381-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-381-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-381-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-381-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-381-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-381-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-381-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-381-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-381-40	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A063029-001	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL			1989-09-20
A063029-002	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL			2005-08-05

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	A063029-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		1989-09-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A063029-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-05	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A063029-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		1989-09-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A063029-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A063029-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		1989-09-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A063029-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A063029-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		1989-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A063029-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063029-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		1989-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063029-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A063029-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		1989-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A063029-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063029-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		1989-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063029-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063029-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		1989-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063029-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063029-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		1989-09-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063029-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063029-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		1989-09-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063029-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063029-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		1989-09-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063029-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063029-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		1989-09-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063029-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A063029-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		1989-09-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A063029-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063029-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		1989-09-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063029-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063029-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		1989-09-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063029-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063029-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		1989-09-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063029-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A063029-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		1989-09-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A063029-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2005-08-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063029-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	1989-09-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063029-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2005-08-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A063029-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	1989-09-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A063029-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2005-08-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A063029-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	1989-09-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A063029-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2005-08-05	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-05-13 08:27 UTC	2023-05	A063029-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A063029-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A063029-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A063029-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A063029-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A063029-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A063029-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A063029-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A063029-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A063029-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A063029-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A063029-002	AB	1	`cb3db0bc1861…`

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
63187-381-20	EA - Each	63187-381	d5060653-56b2-44be-9aab-d84c507e76a6	1	2016-12-07
63187-381-21	EA - Each	63187-381	74fc7163-0d25-435b-a2cd-024e9f009b5d	1	2018-02-20
63187-381-30	EA - Each	63187-381	216e64d9-154a-4652-8b40-f812064ab371	1	2017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-381	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	3	Legacy NDC	20210115_9ff60c5e-a20d-4664-827b-b73153d0f723.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
63187-381-20	63187038120	20 CAPSULE in 1 BOTTLE (63187-381-20)	20 capsule	2016-09-01	0000-00-00	No	No	Current
63187-381-21	63187038121	21 CAPSULE in 1 BOTTLE (63187-381-21)	21 capsule	2016-09-01	0000-00-00	No	No	Current
63187-381-28	63187038128	28 CAPSULE in 1 BOTTLE (63187-381-28)	28 capsule	2016-09-01	0000-00-00	No	No	Current
63187-381-30	63187038130	30 CAPSULE in 1 BOTTLE (63187-381-30)	30 capsule	2016-09-01	0000-00-00	No	No	Current
63187-381-40	63187038140	40 CAPSULE in 1 BOTTLE (63187-381-40)	40 capsule	2016-09-01	0000-00-00	No	No	Current
63187-381-60	63187038160	60 CAPSULE in 1 BOTTLE (63187-381-60)	60 capsule	2016-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLINDAMYCIN HYDROCHLORIDE CAPSULES USP Rx only	Proficient Rx LP	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL	3