CLINDAMYCIN HYDROCHLORIDE

Product NDC: 42571-250
11-digit product format: 425710250
Labeler code: 42571
Product ID: 42571-250_4e518230-035d-d99a-e063-6394a90af9cb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clindamycin hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Micro Labs Limited
Application: ANDA207402
Marketing category: ANDA
Marketing start: 2019-01-07
Substance: CLINDAMYCIN HYDROCHLORIDE
Active strength: 75 mg/1
Pharmacologic classes: Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: CLINDAMYCIN HYDROCHLORIDE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLINDAMYCIN HYDROCHLORIDE	75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
T20OQ1YN1W	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197518	Internal RxNorm lookup
284215	Internal RxNorm lookup
309329	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
9b9f898f-6a91-44f8-9508-f9ddfaad27bc	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42571-250-01	CLINDAMYCIN HYDROCHLORIDE	100 in 1 BOTTLE	CAPSULE	100	13
42571-250-32	CLINDAMYCIN HYDROCHLORIDE	10 in 1 BLISTER PACK	CAPSULE	10	13
42571-250-67	CLINDAMYCIN HYDROCHLORIDE	90 in 1 CARTON	CAPSULE	90	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42571-250-01	EA - Each	42571-250	8a49fbdd-0fbc-4b03-9c5c-d56d202bd74e	1	2019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42571-250	CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) CAPSULE [MICRO LABS LIMITED]	10	Current NDC, Legacy NDC, 3 package rows	20250515_9b9f898f-6a91-44f8-9508-f9ddfaad27bc.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 ndc (product): 42571-250
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	9b9f898f-6a91-44f8-9508-f9ddfaad27bc	13
284215	clindamycin HCl 300 MG Oral Capsule	PSN	9b9f898f-6a91-44f8-9508-f9ddfaad27bc	13
309329	clindamycin HCl 75 MG Oral Capsule	PSN	9b9f898f-6a91-44f8-9508-f9ddfaad27bc	13
197518	clindamycin 150 MG Oral Capsule	SCD	9b9f898f-6a91-44f8-9508-f9ddfaad27bc	13
284215	clindamycin 300 MG Oral Capsule	SCD	9b9f898f-6a91-44f8-9508-f9ddfaad27bc	13
309329	clindamycin 75 MG Oral Capsule	SCD	9b9f898f-6a91-44f8-9508-f9ddfaad27bc	13
197518	clindamycin (as clindamycin HCl) 150 MG Oral Capsule	SY	9b9f898f-6a91-44f8-9508-f9ddfaad27bc	13
284215	clindamycin (as clindamycin HCl) 300 MG Oral Capsule	SY	9b9f898f-6a91-44f8-9508-f9ddfaad27bc	13
309329	clindamycin (as clindamycin hydrochloride) 75 MG Oral Capsule	SY	9b9f898f-6a91-44f8-9508-f9ddfaad27bc	13
197518	clindamycin HCl 150 MG Oral Capsule	PSN	7d3e6ec5-93e9-4ce0-8276-b19aa97eb772	1
284215	clindamycin HCl 300 MG Oral Capsule	PSN	7d3e6ec5-93e9-4ce0-8276-b19aa97eb772	1
309329	clindamycin HCl 75 MG Oral Capsule	PSN	7d3e6ec5-93e9-4ce0-8276-b19aa97eb772	1
197518	clindamycin 150 MG Oral Capsule	SCD	7d3e6ec5-93e9-4ce0-8276-b19aa97eb772	1
284215	clindamycin 300 MG Oral Capsule	SCD	7d3e6ec5-93e9-4ce0-8276-b19aa97eb772	1
309329	clindamycin 75 MG Oral Capsule	SCD	7d3e6ec5-93e9-4ce0-8276-b19aa97eb772	1
197518	clindamycin (as clindamycin HCl) 150 MG Oral Capsule	SY	7d3e6ec5-93e9-4ce0-8276-b19aa97eb772	1
284215	clindamycin (as clindamycin HCl) 300 MG Oral Capsule	SY	7d3e6ec5-93e9-4ce0-8276-b19aa97eb772	1
309329	clindamycin (as clindamycin hydrochloride) 75 MG Oral Capsule	SY	7d3e6ec5-93e9-4ce0-8276-b19aa97eb772	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42571-250-01	42571025001	100 CAPSULE in 1 BOTTLE (42571-250-01)	100 capsule	2019-01-07	0000-00-00	No	No	Current
42571-250-32	42571025032	10 in 1 BLISTER PACK						Historical
42571-250-67	42571025067	90 BLISTER PACK in 1 CARTON (42571-250-67) / 10 CAPSULE in 1 BLISTER PACK (42571-250-32)	90 blister pack	2019-01-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clindamycin Hydrochloride Capsules, USP	Micro Labs Limited	2026-03-31	HUMAN PRESCRIPTION DRUG LABEL	13
Clindamycin Hydrochloride Capsules, USP	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2023-09-14	HUMAN PRESCRIPTION DRUG LABEL	1