clindamycin palmitate hydrochloride

Product NDC: 67787-515
Requested package NDC: 67787-515-71
11-digit product format: 677870515
Labeler code: 67787
Product ID: 67787-515_9f9fadb4-b79a-496f-8af9-fb51d49e627d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clindamycin palmitate hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: InvaGen Pharmaceuticals, Inc.
Application: ANDA206958
Marketing category: ANDA
Marketing start: 2019-09-11
Marketing end: 0000-00-00
Substance: CLINDAMYCIN PALMITATE HYDROCHLORIDE
Active strength: 75 mg/5mL
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	67787-515	67787-515-71	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 · 15 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA		2017-05-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206958-001	AA

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 2 · 41 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	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206958-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2017-05-05	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A206958-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206958-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206958-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206958-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206958-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206958-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206958-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206958-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206958-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206958-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206958-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206958-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206958-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206958-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206958-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206958-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206958-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206958-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206958-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206958-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206958-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206958-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206958-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206958-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206958-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206958-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206958-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206958-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206958-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206958-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206958-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206958-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206958-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206958-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206958-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206958-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206958-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206958-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206958-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206958-001	AA	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67787-515-71	2025-06-17	C162847	48780-1	1030e365-4908-111a-e063-dadaa90a10e2	Clindamycin Palmitate Hydrochloride for Oral Solution, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin palmitate hydrochloride for oral solution and other antibacterial drugs, clindamycin palmitate hydrochloride for oral solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
67787-515-71	2024-01-30	C162847	48780-1	1030e365-4908-111a-e063-dadaa90a10e2	Clindamycin Palmitate Hydrochloride for Oral Solution, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin palmitate hydrochloride for oral solution and other antibacterial drugs, clindamycin palmitate hydrochloride for oral solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67787-515	CLINDAMYCIN PALMITATE HYDROCHLORIDE (PEDIATRIC) (CLINDAMYCIN PALMITATE HYDROCHLORIDE) SOLUTION [INVAGEN PHARMACEUTICALS, INC.]	4	Legacy NDC	20200916_d8cefc80-e0c7-4b18-83d6-5edd4f6f2af4.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clindamycin Palmitate Hydrochloride	CLINDAMYCIN PALMITATE HYDROCHLORIDE	Chartwell RX, LLC	5d120b48-8181-4f40-a0e5-1f5cd0450d4f	2025-09-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206958 application number: ANDA206958

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VN9A8JM7M7	CLINDAMYCIN PALMITATE HYDROCHLORIDE	25507-04-4	CLINDAMYCIN PALMITATE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67787-515-71	67787051571	1 BOTTLE in 1 CARTON (67787-515-71) > 100 mL in 1 BOTTLE	1 bottle	2019-09-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
clindamycin palmitate hydrochloride (pediatric)	InvaGen Pharmaceuticals, Inc.	2020-08-26	Human Prescription Drug Label	4