Clindamycin Palmitate Hydrochloride

Product NDC: 65162-468
11-digit product format: 651620468
Labeler code: 65162
Product ID: 65162-468_4480ac35-28fd-48fc-b0eb-52349d30ad8e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clindamycin Palmitate Hydrochloride
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA203513
Marketing category: ANDA
Marketing start: 2013-09-02
Substance: CLINDAMYCIN PALMITATE HYDROCHLORIDE
Active strength: 75 mg/5mL
Pharmacologic classes: Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL			2014-03-13

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	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203513-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2014-03-13	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203513-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203513-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203513-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203513-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203513-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203513-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203513-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203513-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203513-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203513-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203513-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203513-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203513-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203513-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203513-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203513-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203513-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203513-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203513-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203513-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203513-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203513-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203513-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203513-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203513-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203513-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203513-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203513-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203513-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203513-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203513-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203513-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203513-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203513-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203513-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203513-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203513-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203513-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203513-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203513-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Clindamycin Palmitate Hydrochloride
Brand name suffix: (Pediatric)
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLINDAMYCIN PALMITATE HYDROCHLORIDE	75 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
VN9A8JM7M7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
562266	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a85e28ea-03be-471f-ad7f-f5c55c67ac97	Available on FDA.report

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#

Effective, Related label table
Effective	Related label
2024-02-12	Clindamycin Palmitate Hydrochloride for Oral Solution, USP
2024-02-12	Clindamycin Palmitate Hydrochloride for Oral Solution, USP
2024-01-30	Clindamycin Palmitate Hydrochloride for Oral Solution, USP
2024-01-30	Clindamycin Palmitate Hydrochloride for Oral Solution, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65162-468-19	Clindamycin Palmitate Hydrochloride(Pediatric)	100 mL in 1 BOTTLE	POWDER, FOR SOLUTION	100		17
65162-468-19	Clindamycin Palmitate Hydrochloride(Pediatric)	1 in 1 CARTON	POWDER, FOR SOLUTION	1		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-468-19	ML - Milliliter	65162-468	640d4072-80ae-4bf6-b33b-40845623a545	1	2014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLINDAMYCIN PALMITATE HYDROCHLORIDE	ACTIVE INGREDIENT	VN9A8JM7M7	CLINDAMYCIN PALMITATE HYDROCHLORIDE POWDER, FOR SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	5
CLINDAMYCIN	ACTIVE MOIETY	3U02EL437C	CLINDAMYCIN PALMITATE HYDROCHLORIDE POWDER, FOR SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	5
CHERRY	INACTIVE INGREDIENT	BUC5I9595W	CLINDAMYCIN PALMITATE HYDROCHLORIDE POWDER, FOR SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	5
ETHYLPARABEN	INACTIVE INGREDIENT	14255EXE39	CLINDAMYCIN PALMITATE HYDROCHLORIDE POWDER, FOR SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	5
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	CLINDAMYCIN PALMITATE HYDROCHLORIDE POWDER, FOR SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	5
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	CLINDAMYCIN PALMITATE HYDROCHLORIDE POWDER, FOR SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	5
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CLINDAMYCIN PALMITATE HYDROCHLORIDE POWDER, FOR SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-468	CLINDAMYCIN PALMITATE HYDROCHLORIDE (PEDIATRIC) (CLINDAMYCIN PALMITATE HYDROCHLORIDE) POWDER, FOR SOLUTION [AMNEAL PHARMACEUTICALS LLC]	17	Current NDC, Legacy NDC, 2 package rows	20241027_a85e28ea-03be-471f-ad7f-f5c55c67ac97.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 · 2 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	Amneal Pharmaceuticals of New York LLC	faf67eb8-1fd7-4b2c-a55b-24ba664c0dce	2026-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203513 application number: ANDA203513
Clindamycin Palmitate Hydrochloride (Pediatric)	CLINDAMYCIN PALMITATE HYDROCHLORIDE	Amneal Pharmaceuticals LLC	a85e28ea-03be-471f-ad7f-f5c55c67ac97	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203513 application number: ANDA203513 ndc (product): 65162-468

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
562266	clindamycin palmitate HCl 75 MG in 5 mL Oral Solution	PSN	a85e28ea-03be-471f-ad7f-f5c55c67ac97	17
562266	clindamycin 15 MG/ML Oral Solution	SCD	a85e28ea-03be-471f-ad7f-f5c55c67ac97	17
562266	clindamycin (as clindamycin palmitate HCl) 15 MG/ML Oral Solution	SY	a85e28ea-03be-471f-ad7f-f5c55c67ac97	17
562266	clindamycin 75 MG per 5 ML Powder for Oral Solution	SY	a85e28ea-03be-471f-ad7f-f5c55c67ac97	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-468-19	65162046819	1 BOTTLE in 1 CARTON (65162-468-19) / 100 mL in 1 BOTTLE	1 bottle	2013-09-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clindamycin Palmitate Hydrochloride for Oral Solution, USP	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals of New York, LLC \| Amneal Pharmaceuticals, LLC	2026-05-29	HUMAN PRESCRIPTION DRUG LABEL	18