CLINDAMYCIN PALMITATE HYDROCHLORIDE

Product NDC: 0374-5070
11-digit product format: 003745070
Labeler code: 0374
Product ID: 0374-5070_736b2487-e803-d172-e053-2a91aa0ab0cf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CLINDAMYCIN PALMITATE HYDROCHLORIDE
Dosage form: GRANULE, FOR SOLUTION
Route: ORAL
Labeler: Lyne Laboratories, Inc.
Application: ANDA201821
Marketing category: ANDA
Marketing start: 2012-09-11
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: 2019-12-31
Current FDA listing: Historical FDA.report record

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
A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA		2012-08-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201821-001	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	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201821-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2012-08-28	`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	A201821-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201821-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201821-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201821-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201821-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201821-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201821-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201821-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201821-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201821-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201821-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201821-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201821-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201821-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201821-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201821-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201821-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201821-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201821-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201821-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201821-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201821-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201821-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201821-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201821-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201821-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201821-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201821-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201821-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201821-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201821-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201821-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201821-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201821-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201821-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201821-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201821-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201821-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201821-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201821-001	AA	1	`cb3db0bc1861…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLINDAMYCIN PALMITATE HYDROCHLORIDE (Pediatric)	CLINDAMYCIN PALMITATE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	0800afad-e4cd-4f70-aaa1-a14547be4729	2025-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201821 application number: ANDA201821
CLINDAMYCIN PALMITATE HYDROCHLORIDE (Pediatric)	CLINDAMYCIN PALMITATE HYDROCHLORIDE	Bryant Ranch Prepack	3afe52c2-b65b-40fe-b2fa-da39f1bcf529	2024-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201821 application number: ANDA201821
CLINDAMYCIN PALMITATE HYDROCHLORIDE (Pediatric)	CLINDAMYCIN PALMITATE HYDROCHLORIDE	Bryant Ranch Prepack	28ba03fd-0f9c-49c6-9bfb-cda5417801c6	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201821 application number: ANDA201821

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