Clindamycin Hydrochloride

Product NDC: 50090-0443
11-digit product format: 500900443
Labeler code: 50090
Product ID: 50090-0443_33825777-3310-4c32-9f4b-3e6d12d3315d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clindamycin Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA065442
Marketing category: ANDA
Marketing start: 2009-08-26
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: 2026-12-31
Current FDA listing: Yes

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 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-0443-1	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-0443-0	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-0443-3	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-0443-4	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-0443-7	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-0443-6	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	50090-0443-7	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	50090-0443-4	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	50090-0443-1	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	50090-0443-3	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	50090-0443-0	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	50090-0443-6	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065442-001	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB		2009-08-26
A065442-002	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB		2009-08-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A065442-001	AB
A065442-002	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 3 · 82 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	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A065442-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065442-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065442-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065442-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065442-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065442-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065442-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065442-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065442-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065442-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065442-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065442-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065442-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065442-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065442-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065442-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065442-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065442-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065442-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065442-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065442-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065442-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065442-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065442-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065442-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065442-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065442-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065442-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065442-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065442-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065442-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065442-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065442-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065442-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065442-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065442-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065442-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065442-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065442-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065442-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Clindamycin Hydrochloride
Listing expiration: 2026-12-31

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
8af1493c-1f22-4629-a432-f8b0578189e1	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
50090-0443-0	Clindamycin Hydrochloride	30 in 1 BOTTLE	CAPSULE	30	9
50090-0443-1	Clindamycin Hydrochloride	15 in 1 BOTTLE	CAPSULE	15	9
50090-0443-3	Clindamycin Hydrochloride	4 in 1 BOTTLE	CAPSULE	4	9
50090-0443-4	Clindamycin Hydrochloride	100 in 1 BOTTLE	CAPSULE	100	9
50090-0443-6	Clindamycin Hydrochloride	21 in 1 BOTTLE	CAPSULE	21	9
50090-0443-7	Clindamycin Hydrochloride	42 in 1 BOTTLE	CAPSULE	42	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-0443-0	EA - Each	50090-0443	7237aa3e-9011-40c0-9960-1f4a3f4862fa	1	2018-08-13
50090-0443-1	EA - Each	50090-0443	4932b941-7c95-418d-82eb-fc07ea5173ee	1	2018-09-05
50090-0443-3	EA - Each	50090-0443	9f3bc697-8903-4b7a-99b7-c50a4478ffb0	1	2024-10-04
50090-0443-4	EA - Each	50090-0443	3bb09dfe-e6cc-4287-9377-7753080f2d16	1	2018-09-05
50090-0443-6	EA - Each	50090-0443	67ed8cf4-3377-4a30-b582-be45f248b845	1	2024-10-04
50090-0443-7	EA - Each	50090-0443	bf72a3ce-9cb8-4418-ad61-eb8647ad6d29	1	2018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-0443	CLINDAMYCIN HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]	9	Current NDC, Legacy NDC, 6 package rows	20240905_8af1493c-1f22-4629-a432-f8b0578189e1.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Major Pharmaceuticals	d53a66bf-fdbd-4a12-8d8c-4e3ab94e9ef5	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065442 application number: ANDA065442
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Aurobindo Pharma Limited	2367340c-d297-4a3f-8253-6d27a0ed39cb	2026-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065442 application number: ANDA065442
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Northwind Health Company, LLC	f2f08e98-f6c5-7c2d-e053-2995a90abe1e	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065442 application number: ANDA065442
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Redpharm Drug	0a0fbeae-2bc2-2402-e063-6394a90a97a0	2025-12-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065442 application number: ANDA065442
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	VERITYRX, LLC	427a0138-c2dd-cf0b-e063-6394a90af407	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065442 application number: ANDA065442
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	A-S Medication Solutions	9fe68a5a-487b-4119-9ee7-603948d732e4	2025-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065442 application number: ANDA065442
Clindamycin HCL	CLINDAMYCIN HCL	Advanced Rx Pharmacy of Tennessee, LLC	c46cac0a-0c36-02fa-e053-2995a90a772b	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065442 application number: ANDA065442
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	A-S Medication Solutions	8af1493c-1f22-4629-a432-f8b0578189e1	2024-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065442 application number: ANDA065442 ndc (product): 50090-0443
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	A-S Medication Solutions	2393251d-33b9-4274-9d04-27ec9968eaa1	2024-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065442 application number: ANDA065442
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Proficient Rx LP	d6e1a5f2-9dcb-49fb-a5b0-d7d543520ac3	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065442 application number: ANDA065442

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	8af1493c-1f22-4629-a432-f8b0578189e1	9
197518	clindamycin 150 MG Oral Capsule	SCD	8af1493c-1f22-4629-a432-f8b0578189e1	9
197518	clindamycin (as clindamycin HCl) 150 MG Oral Capsule	SY	8af1493c-1f22-4629-a432-f8b0578189e1	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-0443-0	50090044300	30 CAPSULE in 1 BOTTLE (50090-0443-0)	30 capsule	2016-06-29	No	No	Current
50090-0443-1	50090044301	15 CAPSULE in 1 BOTTLE (50090-0443-1)	15 capsule	2016-06-29	No	No	Current
50090-0443-3	50090044303	4 CAPSULE in 1 BOTTLE (50090-0443-3)	4 capsule	2016-06-29	No	No	Current
50090-0443-4	50090044304	100 CAPSULE in 1 BOTTLE (50090-0443-4)	100 capsule	2016-06-29	No	No	Current
50090-0443-6	50090044306	21 CAPSULE in 1 BOTTLE (50090-0443-6)	21 capsule	2016-06-29	No	No	Current
50090-0443-7	50090044307	42 CAPSULE in 1 BOTTLE (50090-0443-7)	42 capsule	2016-06-29	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clindamycin Hydrochloride Capsules, USP Rx only	A-S Medication Solutions	2024-09-04	Human Prescription Drug Label	9