Clindamycin Hydrochloride

Product NDC: 61919-057
11-digit product format: 619190057
Labeler code: 61919
Product ID: 61919-057_b67323ba-8b04-9b84-e053-2a95a90a4092
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clindamycin Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Direct Rx
Application: ANDA065061
Marketing category: ANDA
Marketing start: 2015-01-01
Marketing end: 0000-00-00
Substance: CLINDAMYCIN HYDROCHLORIDE
Active strength: 150 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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61919-057		I	Inactivated by FDA	2026-08-03
excluded product	product	61919-057		I	Inactivated by FDA	2026-08-03
excluded package	package	61919-057	61919-057-20	I	Inactivated by FDA	2026-08-03
excluded package	package	61919-057	61919-057-21	I	Inactivated by FDA	2026-08-03
excluded package	package	61919-057	61919-057-28	I	Inactivated by FDA	2026-08-03
excluded package	package	61919-057	61919-057-30	I	Inactivated by FDA	2026-08-03
excluded package	package	61919-057	61919-057-40	I	Inactivated by FDA	2026-08-03
excluded package	package	61919-057	61919-057-42	I	Inactivated by FDA	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 2 · 90 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-057-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-057-42	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-057-21	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-057-40	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-057-28	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-057-20	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-057-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-057-42	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-057-21	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-057-40	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-057-28	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-057-20	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-057-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-057-42	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-057-21	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-057-40	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-057-28	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-057-20	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-057-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-057-42	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-057-21	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-057-40	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-057-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-057-20	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-057-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-057-42	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-057-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-057-40	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-057-28	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-057-20	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-057-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-057-42	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-057-21	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-057-40	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-057-28	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-057-20	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-057-42	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-057-30	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-057-40	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-057-20	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-057-28	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-057-21	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-057-42	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-057-30	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`

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
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 · 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	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…`
2019-12-13 00:20 UTC	2019-12	A065061-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2001-02-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065061-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2001-02-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065061-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2001-02-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065061-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2001-02-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065061-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2001-02-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065061-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2001-02-02	`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	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…`
2019-12-13 00:20 UTC	2019-12	A065061-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065061-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065061-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065061-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065061-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065061-002	AB	1	`782e0a99824c…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
61919-057-20	2025-01-30	2cef2736-9bca-d83d-e063-dadaa90ab31f	CLINDAMYCIN HYDROCHLORIDE 150mg
61919-057-21	2025-01-30	9d75b9d0-abfa-f424-e053-dadaa90a57ce	Clindamycin Hydrochloride
61919-057-28	2025-01-30	9d75b9d0-abfa-f424-e053-dadaa90a57ce	Clindamycin Hydrochloride
61919-057-30	2025-01-30	9d75b9d0-abfa-f424-e053-dadaa90a57ce	Clindamycin Hydrochloride
61919-057-40	2025-01-30	9d75b9d0-abfa-f424-e053-dadaa90a57ce	Clindamycin Hydrochloride
61919-057-42	2025-01-30	9d75b9d0-abfa-f424-e053-dadaa90a57ce	Clindamycin Hydrochloride
61919-057-21	2020-12-14	9d75b9d0-abfa-f424-e053-dadaa90a57ce	Clindamycin Hydrochloride
61919-057-28	2020-12-14	9d75b9d0-abfa-f424-e053-dadaa90a57ce	Clindamycin Hydrochloride
61919-057-30	2020-12-14	9d75b9d0-abfa-f424-e053-dadaa90a57ce	Clindamycin Hydrochloride
61919-057-40	2020-12-14	9d75b9d0-abfa-f424-e053-dadaa90a57ce	Clindamycin Hydrochloride
61919-057-42	2020-12-14	9d75b9d0-abfa-f424-e053-dadaa90a57ce	Clindamycin Hydrochloride
61919-057-21	2020-01-31	9d75b9d0-abfa-f424-e053-dadaa90a57ce	Clindamycin Hydrochloride
61919-057-28	2020-01-31	9d75b9d0-abfa-f424-e053-dadaa90a57ce	Clindamycin Hydrochloride
61919-057-30	2020-01-31	9d75b9d0-abfa-f424-e053-dadaa90a57ce	Clindamycin Hydrochloride
61919-057-40	2020-01-31	9d75b9d0-abfa-f424-e053-dadaa90a57ce	Clindamycin Hydrochloride
61919-057-42	2020-01-31	9d75b9d0-abfa-f424-e053-dadaa90a57ce	Clindamycin Hydrochloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-057-21	Clindamycin Hydrochloride	21 in 1 BOTTLE	CAPSULE	21	6
61919-057-28	Clindamycin Hydrochloride	28 in 1 BOTTLE	CAPSULE	28	6
61919-057-30	Clindamycin Hydrochloride	30 in 1 BOTTLE	CAPSULE	30	6
61919-057-40	Clindamycin Hydrochloride	40 in 1 BOTTLE	CAPSULE	40	6
61919-057-42	Clindamycin Hydrochloride	42 in 1 BOTTLE	CAPSULE	42	6
61919-057-20	CLINDAMYCIN HYDROCHLORIDE	20 in 1 BOTTLE	CAPSULE	20	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-057-20	EA - Each	61919-057	02179f2f-8226-4575-b51d-0021c524f3de	1	2019-08-06
61919-057-21	EA - Each	61919-057	90d219b4-365b-4cf5-ba5c-53b7474c57d8	1	2016-09-02
61919-057-30	EA - Each	61919-057	e7c3fb42-8282-494e-a2fc-1d7d484e2a8f	1	2015-10-02
61919-057-40	EA - Each	61919-057	81c257a3-bccb-4b3b-b0a3-b52e1e35b75a	1	2016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLINDAMYCIN HYDROCHLORIDE	ACTIVE INGREDIENT	T20OQ1YN1W	CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]	3
CLINDAMYCIN	ACTIVE MOIETY	3U02EL437C	CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]	3
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-057	CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]	6	Legacy NDC, 5 package rows	20230401_9b993b19-e471-46ac-8bd3-40968796a30e.zip
61919-057	CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]	2	Legacy NDC, 1 package rows	20200129_2ebc6f29-d014-4c86-e054-00144ff8d46c.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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	HAWAII REPACK, INC.	c6703df0-b41d-439f-8e0d-d30b3039b3f8	2026-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	fadc321a-2291-4268-936f-0743fdddbe7f	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Major Pharmaceuticals	f9e6ed50-ad03-4a9e-8760-8733e04a058c	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	1dbd8448-c1e5-46df-8060-50ef82380445	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Unit Dose Solutions, Inc.	535e7e17-d020-4aa6-e063-6294a90ae114	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Golden State Medical Supply, Inc.	a69260bb-31b5-4f77-e053-2995a90a37e1	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	REMEDYREPACK INC.	7f7fc73a-86e1-4d3e-8c83-1c74621e4af4	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Cardinal Health 107, LLC	b22be885-f441-473e-879a-862588dcf89d	2026-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Northwind Health Company, LLC	f781897a-ab54-7373-e053-6294a90a89a3	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	4730ab20-09e2-d32a-e063-6394a90ae125	2025-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	American Health Packaging	3f6b2c5a-e581-414f-bc9e-eaf66a5685cd	2025-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin HCL	CLINDAMYCIN HCL	Advanced Rx of Tennessee, LLC	b43dc396-17ef-a523-e053-2a95a90ac872	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	2b13d66d-4f48-477e-ba32-20e85d0e708d	2024-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	7537fbab-c792-4b77-8736-c24b69cf48ea	2024-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	678912ff-a0c1-171b-e053-2991aa0ad128	2024-06-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	63f26644-b7ab-98c1-e053-2a91aa0af5d3	2024-06-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	A-S Medication Solutions	337870c6-11e0-4d1a-a26e-afe042ee08c3	2024-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	A-S Medication Solutions	600c5ac7-64f7-44ac-9e83-cc1036471eec	2023-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	A-S Medication Solutions	22bf9385-cad3-43a7-802f-131b6826b5a5	2023-09-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065061 application number: ANDA065061
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Asclemed USA, Inc.	cd5a1db8-9ddf-4de3-b856-bc3e8fb29061	2023-05-02	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197518	clindamycin HCl 150 MG Oral Capsule	PSN	9b993b19-e471-46ac-8bd3-40968796a30e	6
197518	clindamycin 150 MG Oral Capsule	SCD	9b993b19-e471-46ac-8bd3-40968796a30e	6
197518	clindamycin (as clindamycin HCl) 150 MG Oral Capsule	SY	9b993b19-e471-46ac-8bd3-40968796a30e	6
197518	clindamycin HCl 150 MG Oral Capsule	PSN	2ebc6f29-d014-4c86-e054-00144ff8d46c	2
197518	clindamycin 150 MG Oral Capsule	SCD	2ebc6f29-d014-4c86-e054-00144ff8d46c	2
197518	clindamycin (as clindamycin HCl) 150 MG Oral Capsule	SY	2ebc6f29-d014-4c86-e054-00144ff8d46c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-057-20	61919005720	20 CAPSULE in 1 BOTTLE (61919-057-20)	20 capsule	2016-03-02	0000-00-00	No	No	Current
61919-057-21	61919005721	21 CAPSULE in 1 BOTTLE (61919-057-21)	21 capsule	2015-01-01	0000-00-00	No	No	Current
61919-057-28	61919005728	28 CAPSULE in 1 BOTTLE (61919-057-28)	28 capsule	2015-01-01	0000-00-00	No	No	Current
61919-057-30	61919005730	30 CAPSULE in 1 BOTTLE (61919-057-30)	30 capsule	2015-01-01	0000-00-00	No	No	Current
61919-057-40	61919005740	40 CAPSULE in 1 BOTTLE (61919-057-40)	40 capsule	2015-01-01	0000-00-00	No	No	Current
61919-057-42	61919005742	42 CAPSULE in 1 BOTTLE (61919-057-42)	42 capsule	2015-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clindamycin Hydrochloride	Direct Rx	2023-03-31	HUMAN PRESCRIPTION DRUG LABEL	6
CLINDAMYCIN HYDROCHLORIDE 150mg	DIRECT RX	2020-01-20	HUMAN PRESCRIPTION DRUG LABEL	2