Clindamycin Hydrochloride

Product NDC: 68788-8558
Requested package NDC: 68788-8558-2
11-digit product format: 687888558
Labeler code: 68788
Product ID: 68788-8558_b6d64357-e0fc-48fc-9cf3-2a7cd550d333
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clindamycin Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA216957
Marketing category: ANDA
Marketing start: 2023-12-21
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: 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
A216957-001	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-03-10
A216957-002	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2023-03-10
A216957-003	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2023-03-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216957-001	AB
A216957-002	AB
A216957-003	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 2 · 69 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	A216957-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216957-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2023-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216957-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2023-03-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216957-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216957-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2023-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216957-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2023-03-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216957-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216957-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2023-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216957-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2023-03-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216957-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216957-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2023-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216957-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2023-03-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216957-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-03-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216957-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2023-03-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216957-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2023-03-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216957-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-03-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216957-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2023-03-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216957-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2023-03-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216957-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-03-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216957-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2023-03-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216957-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2023-03-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216957-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-03-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216957-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2023-03-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216957-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2023-03-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216957-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-03-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216957-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2023-03-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216957-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2023-03-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216957-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-03-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216957-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2023-03-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216957-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2023-03-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216957-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-03-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216957-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2023-03-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216957-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2023-03-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216957-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-03-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216957-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2023-03-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216957-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2023-03-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216957-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-03-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216957-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2023-03-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216957-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2023-03-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216957-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-03-10	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 69 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	A216957-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216957-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216957-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216957-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216957-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216957-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216957-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216957-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216957-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216957-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216957-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216957-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216957-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216957-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216957-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216957-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216957-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216957-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216957-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216957-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216957-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216957-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216957-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216957-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216957-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216957-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216957-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216957-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216957-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216957-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216957-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216957-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216957-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216957-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216957-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216957-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216957-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216957-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216957-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216957-001	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	150 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197518	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
51dfa3fa-6f6a-4904-a8d3-b5938cf9c852	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
68788-8558-0	Clindamycin Hydrochloride	12 in 1 BOTTLE	CAPSULE	12	3
68788-8558-1	Clindamycin Hydrochloride	14 in 1 BOTTLE	CAPSULE	14	3
68788-8558-2	Clindamycin Hydrochloride	20 in 1 BOTTLE	CAPSULE	20	3
68788-8558-3	Clindamycin Hydrochloride	30 in 1 BOTTLE	CAPSULE	30	3
68788-8558-5	Clindamycin Hydrochloride	56 in 1 BOTTLE	CAPSULE	56	3
68788-8558-6	Clindamycin Hydrochloride	60 in 1 BOTTLE	CAPSULE	60	3
68788-8558-7	Clindamycin Hydrochloride	21 in 1 BOTTLE	CAPSULE	21	3
68788-8558-8	Clindamycin Hydrochloride	28 in 1 BOTTLE	CAPSULE	28	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8558-5	EA - Each	68788-8558	331b69b3-4c1c-4b39-8104-c405e94c50df	1	2024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8558	CLINDAMYCIN HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]	2	Current NDC, 8 package rows	20250305_51dfa3fa-6f6a-4904-a8d3-b5938cf9c852.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 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	1dd9e6b0-bcf4-5bf4-e063-6394a90a10c2	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216957 application number: ANDA216957
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	47f76d99-2024-4531-a527-66c80deeeb37	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216957 application number: ANDA216957
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	ST. MARY'S MEDICAL PARK PHARMACY	1f1b9230-b8ef-b0e4-e063-6394a90afc47	2026-06-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216957 application number: ANDA216957
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	e4d91d51-b92e-4d3e-8379-f9463f450537	2026-05-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216957 application number: ANDA216957
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Proficient Rx LP	d1aa1e91-4ac8-40d1-9fc4-963e1c9c3278	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216957 application number: ANDA216957
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Coupler LLC	509a9bc3-0901-0874-e063-6294a90a8816	2026-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216957 application number: ANDA216957
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	REMEDYREPACK INC.	87db8bce-1b6f-4f1b-ab62-b3778c429b2e	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216957 application number: ANDA216957
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	4f0ddf1a-eda6-8ca8-e063-6294a90a4102	2026-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216957 application number: ANDA216957
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	51dfa3fa-6f6a-4904-a8d3-b5938cf9c852	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216957 application number: ANDA216957 ndc (package): 68788-8558-2 ndc (product): 68788-8558 ndc11 (package): 68788855802
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	adf8f0fa-f794-4e97-a7b3-16b55d9c9a68	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216957 application number: ANDA216957
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	GLENMARK PHARMACEUTICALS INC., USA	8e66de7a-d9d4-4562-bc99-80489d482da4	2026-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216957 application number: ANDA216957
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Sportpharm LLC	3bddb5d2-ddac-2f03-e063-6294a90aa68c	2026-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216957 application number: ANDA216957
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	A-S Medication Solutions	ebdcd3ce-3140-4bf6-b8b8-468ead08d9a9	2026-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216957 application number: ANDA216957
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Redpharm Drug	3256c93b-f26c-aeb9-e063-6394a90ae9c2	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216957 application number: ANDA216957
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	A-S Medication Solutions	09eea0ad-702f-4eea-bfb9-81effc76b22b	2025-10-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216957 application number: ANDA216957
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	REMEDYREPACK INC.	fa084aad-07fa-44d2-8d01-d32f40acd2f3	2025-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216957 application number: ANDA216957
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	12dea490-e179-f295-e063-6394a90af4aa	2025-04-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216957 application number: ANDA216957
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Brisk Pharmaceuticals	2de041be-1d36-ee95-e063-6294a90a2091	2025-02-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216957 application number: ANDA216957
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	2178249b-a9fe-5015-e063-6294a90a9ff4	2024-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216957 application number: ANDA216957
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	A-S Medication Solutions	7b110bab-815e-4654-860b-b9142fd93d45	2024-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216957 application number: ANDA216957

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	51dfa3fa-6f6a-4904-a8d3-b5938cf9c852	3
197518	clindamycin 150 MG Oral Capsule	SCD	51dfa3fa-6f6a-4904-a8d3-b5938cf9c852	3
197518	clindamycin (as clindamycin HCl) 150 MG Oral Capsule	SY	51dfa3fa-6f6a-4904-a8d3-b5938cf9c852	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-8558-2	68788855802	20 CAPSULE in 1 BOTTLE (68788-8558-2)	20 capsule	2025-03-03	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clindamycin Hydrochloride Capsules, USP	Preferred Pharmaceuticals Inc.	2026-03-30	HUMAN PRESCRIPTION DRUG LABEL	3