Clindamycin Hydrochloride

Manufacturer: Aurobindo Pharma Limited
Effective date: 2019-11-06
Label type: Human Prescription Drug Label
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-02 00:02:43

Label at a glance#

ProductClindamycin Hydrochloride

Active ingredientCLINDAMYCIN HYDROCHLORIDE

Label structure3 sections

Label contents#

Full prescribing information#

Description Section

Clindamycin Hydrochloride Capsules

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg Bulk Capsule Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2,000 Capsules

Batch      :

Mfg         :

Expiry     :

To be repacked within six months from the date of manufacturing

NDC 65862-185-22

BULK SHIPMENT
PLEASE HANDLE CAREFULLY

Rx only

Clindamycin Hydrochloride Capsules, USP
150 mg*

*Each capsule contains: Clindamycin hydrochloride USP equivalent to 150 mg of clindamycin.

CAUTION: FOR REPACKAGING ONLY

Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86º) [see USP Controlled Room Temperature].

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 090, India

M.L.No.: 19/HD/AP/95/F/R

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 300 mg Bulk Capsule Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1,500 Capsules

Batch      :

Mfg         :

Expiry      :

To be repacked within six months from the date of manufacturing

NDC 65862-186-15

BULK SHIPMENT
PLEASE HANDLE CAREFULLY

Rx only

Clindamycin Hydrochloride Capsules, USP
300 mg*

*Each capsule contains: Clindamycin hydrochloride USP equivalent to 300 mg of clindamycin.

CAUTION: FOR REPACKAGING ONLY

Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86º) [see USP Controlled Room Temperature].

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 090, India

M.L.No.: 19/HD/AP/95/F/R

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 300 mg Bulk Capsule Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-185-01	EA - Each	65862-185	49862960-e331-4baa-8bae-c4882f2ec3c9	1	2012-07-24
65862-185-05	EA - Each	65862-185	aca80404-6b6a-49a8-b0d6-f28de0a1b8e5	1	2012-07-24
65862-186-01	EA - Each	65862-186	190e0f2b-0860-4832-a239-e03c64a877a1	1	2012-07-24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

Clindamycin Hydrochloride
CLINDAMYCIN
LACTOSE MONOHYDRATE
STARCH, CORN
TALC
MAGNESIUM STEARATE
FD&C BLUE NO. 1
TITANIUM DIOXIDE
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
SHELLAC

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65862-185	65862-185-22
65862-186	65862-186-15

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CLINDAMYCIN HYDROCHLORIDE	T20OQ1YN1W	ACTIM
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
STARCH, CORN	O8232NY3SJ	IACT
TALC	7SEV7J4R1U	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
GELATIN, UNSPECIFIED	2G86QN327L	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
SHELLAC	46N107B71O	IACT
CLINDAMYCIN HYDROCHLORIDE	T20OQ1YN1W	ACTIM
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
STARCH, CORN	O8232NY3SJ	IACT
TALC	7SEV7J4R1U	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
GELATIN, UNSPECIFIED	2G86QN327L	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
SHELLAC	46N107B71O	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 86 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
2026-09-14 22:38:34	2026-08	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065442-001	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2009-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065442-002	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2009-08-26	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A065442-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065442-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065442-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065442-002	AB	1	`caaa826d4ba7…`
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…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
a0d090e3-0ddf-4e2d-9c94-7f196431398f			412c6015-45ec-4abb-a43b-6abaf5bc7fc5	2019-11-14		Exact identifier spl set id: 412c6015-45ec-4abb-a43b-6abaf5bc7fc5

Reported adverse events (FAERS/openFDA)#

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