clindamycin hydrochloride

Product NDC: 59762-3328
Requested package NDC: 59762-3328-1
11-digit product format: 597623328
Labeler code: 59762
Product ID: 59762-3328_8b018de8-bd9a-493a-9069-1f54fcec2069
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clindamycin hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Greenstone LLC
Application: NDA050162
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 1970-05-22
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	59762-3328	59762-3328-1	D	Discontinued by firm		2026-10-15

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	RLD / RS	Approval date
N050162-001	CLEOCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982
N050162-002	CLEOCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982
N050162-003	CLEOCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	1988-04-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050162-001	AB
N050162-002	AB
N050162-003	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 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N050162-001	CLEOCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N050162-002	CLEOCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N050162-003	CLEOCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	1988-04-14	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N050162-001	CLEOCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050162-002	CLEOCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050162-003	CLEOCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	1988-04-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050162-001	CLEOCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050162-002	CLEOCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050162-003	CLEOCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	1988-04-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050162-001	CLEOCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050162-002	CLEOCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050162-003	CLEOCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	1988-04-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050162-001	CLEOCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050162-002	CLEOCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050162-003	CLEOCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	1988-04-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050162-001	CLEOCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050162-002	CLEOCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050162-003	CLEOCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	1988-04-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050162-001	CLEOCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050162-002	CLEOCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050162-003	CLEOCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	1988-04-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050162-001	CLEOCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050162-002	CLEOCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050162-003	CLEOCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	1988-04-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050162-001	CLEOCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050162-002	CLEOCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050162-003	CLEOCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	1988-04-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050162-001	CLEOCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050162-002	CLEOCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050162-003	CLEOCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	1988-04-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050162-001	CLEOCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050162-002	CLEOCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050162-003	CLEOCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	1988-04-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050162-001	CLEOCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050162-002	CLEOCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050162-003	CLEOCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	1988-04-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050162-001	CLEOCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050162-002	CLEOCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050162-003	CLEOCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	RLD, RS	1988-04-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050162-001	CLEOCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N050162-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N050162-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N050162-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N050162-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050162-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050162-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050162-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050162-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050162-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050162-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050162-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050162-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050162-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050162-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050162-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050162-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050162-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050162-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050162-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050162-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050162-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050162-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050162-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050162-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050162-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050162-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050162-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050162-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050162-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050162-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050162-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050162-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050162-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050162-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050162-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050162-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050162-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050162-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050162-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050162-001	AB	1	`79d66fd596c7…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
59762-3328-1	clindamycin hydrochloride	100 in 1 BOTTLE	CAPSULE	100		35

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59762-3328-1	EA - Each	59762-3328	65727522-7852-4c87-b73e-739f50729f5f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLINDAMYCIN HYDROCHLORIDE	ACTIVE INGREDIENT	T20OQ1YN1W	CLINDAMYCIN HYDROCHLORIDE CAPSULE [GREENSTONE LLC]	10
CLINDAMYCIN	ACTIVE MOIETY	3U02EL437C	CLINDAMYCIN HYDROCHLORIDE CAPSULE [GREENSTONE LLC]	10
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CLINDAMYCIN HYDROCHLORIDE CAPSULE [GREENSTONE LLC]	10
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	CLINDAMYCIN HYDROCHLORIDE CAPSULE [GREENSTONE LLC]	10
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CLINDAMYCIN HYDROCHLORIDE CAPSULE [GREENSTONE LLC]	10
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	CLINDAMYCIN HYDROCHLORIDE CAPSULE [GREENSTONE LLC]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLINDAMYCIN HYDROCHLORIDE CAPSULE [GREENSTONE LLC]	10
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLINDAMYCIN HYDROCHLORIDE CAPSULE [GREENSTONE LLC]	10
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CLINDAMYCIN HYDROCHLORIDE CAPSULE [GREENSTONE LLC]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CLINDAMYCIN HYDROCHLORIDE CAPSULE [GREENSTONE LLC]	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59762-3328	CLINDAMYCIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	32	Legacy NDC, 1 package rows	20250529_24595bb3-07ea-4d5f-9bb3-2c2332a1fc62.zip

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	24595bb3-07ea-4d5f-9bb3-2c2332a1fc62	35
284215	clindamycin HCl 300 MG Oral Capsule	PSN	24595bb3-07ea-4d5f-9bb3-2c2332a1fc62	35
197518	clindamycin 150 MG Oral Capsule	SCD	24595bb3-07ea-4d5f-9bb3-2c2332a1fc62	35
284215	clindamycin 300 MG Oral Capsule	SCD	24595bb3-07ea-4d5f-9bb3-2c2332a1fc62	35
197518	clindamycin (as clindamycin HCl) 150 MG Oral Capsule	SY	24595bb3-07ea-4d5f-9bb3-2c2332a1fc62	35
284215	clindamycin (as clindamycin HCl) 300 MG Oral Capsule	SY	24595bb3-07ea-4d5f-9bb3-2c2332a1fc62	35

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59762-3328-1	59762332801	100 CAPSULE in 1 BOTTLE (59762-3328-1)	100 capsule	1970-05-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clindamycin Hydrochloride capsules, USP	Mylan Pharmaceuticals Inc. \| Pfizer Inc	2026-04-28	HUMAN PRESCRIPTION DRUG LABEL	35