CLINDAMYCIN HYDROCHLORIDE

Product NDC: 53002-2321
Requested package NDC: 53002-2321-5
11-digit product format: 530022321
Labeler code: 53002
Product ID: 53002-2321_d6da6ed6-4099-4bfa-888e-4afdd4835601
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clindamycin hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA207402
Marketing category: ANDA
Marketing start: 2019-01-07
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], Neuromuscular Blockade [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	53002-2321	53002-2321-5	I	Inactivated by FDA		2026-08-07

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 · 9 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	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`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	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A207402-001	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-11-05
A207402-002	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-11-05
A207402-003	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-11-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A207402-001	AB
A207402-002	AB
A207402-003	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 4 · 123 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	A207402-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207402-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207402-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207402-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207402-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207402-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207402-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207402-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207402-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207402-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207402-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207402-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207402-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207402-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207402-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207402-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207402-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207402-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207402-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207402-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207402-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207402-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207402-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207402-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207402-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207402-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207402-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207402-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-11-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207402-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-11-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207402-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207402-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-11-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207402-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-11-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207402-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207402-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-11-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207402-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-11-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207402-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207402-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-11-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207402-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-11-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207402-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207402-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-11-05	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A207402-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207402-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207402-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207402-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207402-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207402-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207402-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207402-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207402-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207402-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207402-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207402-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207402-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207402-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207402-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207402-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207402-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207402-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207402-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207402-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207402-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207402-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207402-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207402-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207402-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207402-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207402-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207402-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207402-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207402-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207402-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207402-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207402-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207402-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207402-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207402-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207402-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207402-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207402-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207402-001	AB	1	`8072bd15b7f6…`

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, Related label table
NDC	Related label
53002-2321-0	Clindamycin Hydrochloride Capsules, USP
53002-2321-1	Clindamycin Hydrochloride Capsules, USP
53002-2321-2	Clindamycin Hydrochloride Capsules, USP
53002-2321-3	Clindamycin Hydrochloride Capsules, USP
53002-2321-4	Clindamycin Hydrochloride Capsules, USP
53002-2321-5	Clindamycin Hydrochloride Capsules, USP
53002-2321-6	Clindamycin Hydrochloride Capsules, USP
53002-2321-7	Clindamycin Hydrochloride Capsules, USP
53002-2321-8	Clindamycin Hydrochloride Capsules, USP
53002-2321-9	Clindamycin Hydrochloride Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53002-2321-0	CLINDAMYCIN HYDROCHLORIDE	60 in 1 BOTTLE	CAPSULE	60	1
53002-2321-1	CLINDAMYCIN HYDROCHLORIDE	8 in 1 BOTTLE	CAPSULE	8	1
53002-2321-2	CLINDAMYCIN HYDROCHLORIDE	20 in 1 BOTTLE	CAPSULE	20	1
53002-2321-3	CLINDAMYCIN HYDROCHLORIDE	21 in 1 BOTTLE	CAPSULE	21	1
53002-2321-4	CLINDAMYCIN HYDROCHLORIDE	28 in 1 BOTTLE	CAPSULE	28	1
53002-2321-5	CLINDAMYCIN HYDROCHLORIDE	30 in 1 BOTTLE	CAPSULE	30	1
53002-2321-6	CLINDAMYCIN HYDROCHLORIDE	40 in 1 BOTTLE	CAPSULE	40	1
53002-2321-7	CLINDAMYCIN HYDROCHLORIDE	80 in 1 BOTTLE	CAPSULE	80	1
53002-2321-8	CLINDAMYCIN HYDROCHLORIDE	42 in 1 BOTTLE	CAPSULE	42	1
53002-2321-9	CLINDAMYCIN HYDROCHLORIDE	56 in 1 BOTTLE	CAPSULE	56	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-2321	CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) CAPSULE [RPK PHARMACEUTICALS, INC.]	1	Legacy NDC, 10 package rows	20220331_de7ff699-528a-4f62-b511-f004aec8dc79.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 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	REMEDYREPACK INC.	f4c4fce0-0472-45a3-b4c6-192d97ca1818	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	8e3c9cf6-ab39-4fb5-94e3-232880c47700	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	de7001d1-8b83-4f8b-8e50-c07691021456	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	5f6a85c5-dca3-49b1-a029-3818a41d49bf	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	afeb96ed-7c2e-72d3-e053-2995a90a4ed3	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	Micro Labs Limited	9b9f898f-6a91-44f8-9508-f9ddfaad27bc	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	bde81d4b-ad21-cc09-e053-2995a90a8c01	2026-02-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	ba9bd5cd-036b-4b0c-e053-2a95a90a332e	2026-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	RedPharm Drug, Inc.	a2f6fa76-a114-4104-e053-2a95a90a9e0b	2026-01-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	Northwind Health Company, LLC	f6f5c8b2-83a1-5362-e053-6394a90aaaad	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	cd2ca915-5672-440d-a14e-b4d3b6a522f3	2025-09-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	DIRECT RX	c3f35f80-e4ae-95f5-e053-2995a90a1b64	2025-07-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	Quality Care Products, LLC	1d562ae9-5a9a-4fed-8cc7-3f30fb40f957	2024-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	bea7de4c-c077-4535-96a0-f6b319120b0b	2024-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	b2bd8402-c887-5bfd-e053-2a95a90a15d9	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	1d760cb7-d166-6707-e063-6394a90a8850	2024-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	9e68cb17-73d9-8a00-e053-2995a90a517f	2024-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	9fe44bdd-eb59-4b55-e053-2995a90a3183	2024-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	AvPAK	b2a810f1-c009-e973-e053-2a95a90ad5b0	2024-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	Asclemed USA, Inc.	7d3e6ec5-93e9-4ce0-8276-b19aa97eb772	2023-09-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402

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	de7ff699-528a-4f62-b511-f004aec8dc79	1
197518	clindamycin 150 MG Oral Capsule	SCD	de7ff699-528a-4f62-b511-f004aec8dc79	1
197518	clindamycin (as clindamycin HCl) 150 MG Oral Capsule	SY	de7ff699-528a-4f62-b511-f004aec8dc79	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-2321-5	53002232105	30 CAPSULE in 1 BOTTLE (53002-2321-5)	30 capsule	2021-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clindamycin Hydrochloride Capsules, USP	RPK Pharmaceuticals, Inc.	2022-03-30	HUMAN PRESCRIPTION DRUG LABEL	1