Clindamycin Hydrochloride by Aurobindo Pharma Limited

Clindamycin Hydrochloride by

Drug Labeling and Warnings

Clindamycin Hydrochloride by is a Prescription medication manufactured, distributed, or labeled by Aurobindo Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CLINDAMYCIN HYDROCHLORIDE - clindamycin hydrochloride capsule 
Aurobindo Pharma Limited

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Clindamycin Hydrochloride Capsules

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


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 - 150 mg Bulk Capsule Label


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



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


 

CLINDAMYCIN HYDROCHLORIDE 
clindamycin hydrochloride capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 65862-185
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLINDAMYCIN HYDROCHLORIDE (UNII: T20OQ1YN1W) (CLINDAMYCIN - UNII:3U02EL437C) CLINDAMYCIN150 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SHELLAC (UNII: 46N107B71O)  
Product Characteristics
ColorBLUE (Light Blue Opaque) , GREEN (Light Green Transparent) Scoreno score
ShapeCAPSULESize19mm
FlavorImprint Code C;39
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65862-185-222000 in 1 BAG; Type 0: Not a Combination Product08/26/200911/14/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06544208/26/200911/14/2019
CLINDAMYCIN HYDROCHLORIDE 
clindamycin hydrochloride capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 65862-186
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLINDAMYCIN HYDROCHLORIDE (UNII: T20OQ1YN1W) (CLINDAMYCIN - UNII:3U02EL437C) CLINDAMYCIN300 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SHELLAC (UNII: 46N107B71O)  
Product Characteristics
ColorBLUE (Light Blue Opaque) Scoreno score
ShapeCAPSULESize21mm
FlavorImprint Code C;40
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65862-186-151500 in 1 BAG; Type 0: Not a Combination Product08/26/200911/14/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06544208/26/200911/14/2019
Labeler - Aurobindo Pharma Limited (650082092)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited918917642ANALYSIS(65862-185, 65862-186) , MANUFACTURE(65862-185, 65862-186)

Revised: 11/2019
Document Id: a0d090e3-0ddf-4e2d-9c94-7f196431398f
Set id: 412c6015-45ec-4abb-a43b-6abaf5bc7fc5
Version: 5
Effective Time: 20191114