Clindamycin Palmitate Hydrochloride

Product NDC: 63629-2523
Requested package NDC: 63629-2523-1
11-digit product format: 636292523
Labeler code: 63629
Product ID: 63629-2523_d82ab990-9080-4bad-b24c-1db12b799dc6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clindamycin Palmitate Hydrochloride
Dosage form: GRANULE, FOR SOLUTION
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA090902
Marketing category: ANDA
Marketing start: 2010-01-21
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

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	63629-2523	63629-2523-1	D	Discontinued by firm		2026-08-03

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
A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL			2010-07-07

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	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090902-001	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION / ORAL	AA	2010-07-07	`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	A090902-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090902-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090902-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090902-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090902-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090902-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090902-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090902-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090902-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090902-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090902-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090902-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090902-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090902-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090902-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090902-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090902-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090902-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090902-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090902-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090902-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090902-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090902-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090902-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090902-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090902-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090902-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090902-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090902-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090902-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090902-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090902-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090902-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090902-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090902-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090902-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090902-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090902-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090902-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090902-001	AA	1	`cb3db0bc1861…`

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63629-2523-1	Clindamycin Palmitate Hydrochloride	100 mL in 1 BOTTLE, GLASS	GRANULE, FOR SOLUTION	100		103
63629-2523-1	Clindamycin Palmitate Hydrochloride	1 in 1 CARTON	GRANULE, FOR SOLUTION	1		103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-2523-1	ML - Milliliter	63629-2523	fa71c2ca-b126-4209-bb32-793a16422256	1	2021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-2523	CLINDAMYCIN PALMITATE HYDROCHLORIDE GRANULE, FOR SOLUTION [BRYANT RANCH PREPACK]	103	Current NDC, Legacy NDC, 2 package rows	20231207_4f2ce6e5-b56b-4028-ae6f-4744fc63c99e.zip

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	4f2ce6e5-b56b-4028-ae6f-4744fc63c99e	103
562266	clindamycin 15 MG/ML Oral Solution	SCD	4f2ce6e5-b56b-4028-ae6f-4744fc63c99e	103
562266	clindamycin (as clindamycin palmitate HCl) 15 MG/ML Oral Solution	SY	4f2ce6e5-b56b-4028-ae6f-4744fc63c99e	103
562266	clindamycin 75 MG per 5 ML Powder for Oral Solution	SY	4f2ce6e5-b56b-4028-ae6f-4744fc63c99e	103

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-2523-1	63629252301	1 BOTTLE, GLASS in 1 CARTON (63629-2523-1) / 100 mL in 1 BOTTLE, GLASS	2010-01-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clindamycin Palmitate Hydrochloride for Oral Solution, USP	Bryant Ranch Prepack	2023-12-06	HUMAN PRESCRIPTION DRUG LABEL	103