MINOCYCLINE HYDROCHLORIDE- minocycline hydrochloride capsule 
Cadila Healthcare Limited

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Minocycline Hydrochloride Capsules, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1426-1

Minocycline Hydrochloride Capsules USP, 50 mg

100 Capsules

Rx only

mino 50mg SEZ

NDC 70771-1427-1

Minocycline Hydrochloride Capsules USP, 75 mg

100 Capsules

Rx only

Minocycline Capsules, 75 mg

NDC 70771-1428-7

Minocycline Hydrochloride Capsules USP, 100 mg

50 Capsules

Rx only

mino 100mg SEZ
MINOCYCLINE HYDROCHLORIDE 
minocycline hydrochloride capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1426
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOCYCLINE HYDROCHLORIDE (UNII: 0020414E5U) (MINOCYCLINE - UNII:FYY3R43WGO) MINOCYCLINE50 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
GELATIN (UNII: 2G86QN327L)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SHELLAC (UNII: 46N107B71O)  
AMMONIA (UNII: 5138Q19F1X)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
Product Characteristics
ColorPINK (pink body and cap) Scoreno score
ShapeCAPSULE (CAPSULE) Size16mm
FlavorImprint Code 316
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1426-1100 in 1 BOTTLE; Type 0: Not a Combination Product04/03/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06301104/03/2017
MINOCYCLINE HYDROCHLORIDE 
minocycline hydrochloride capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1427
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOCYCLINE HYDROCHLORIDE (UNII: 0020414E5U) (MINOCYCLINE - UNII:FYY3R43WGO) MINOCYCLINE75 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorGRAY (light gray opaque body and white opaque cap) Scoreno score
ShapeCAPSULE (CAPSULE) Size16mm
FlavorImprint Code 317
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1427-1100 in 1 BOTTLE; Type 0: Not a Combination Product04/03/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06300904/03/2017
MINOCYCLINE HYDROCHLORIDE 
minocycline hydrochloride capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1428
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOCYCLINE HYDROCHLORIDE (UNII: 0020414E5U) (MINOCYCLINE - UNII:FYY3R43WGO) MINOCYCLINE100 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM OXIDE (UNII: LMI26O6933)  
AMMONIA (UNII: 5138Q19F1X)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPINK (pink body and maroon cap) Scoreno score
ShapeCAPSULE (CAPSULE) Size18mm
FlavorImprint Code 318
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1428-750 in 1 BOTTLE; Type 0: Not a Combination Product04/03/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06300904/03/2017
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (863362789)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited863362789ANALYSIS(70771-1426, 70771-1427, 70771-1428) , MANUFACTURE(70771-1426, 70771-1427, 70771-1428)

Revised: 7/2020
Document Id: 4c5b6e0e-c39e-4c7e-a711-2c48bfa80339
Set id: 26ee99af-f44b-4076-a08c-0a0dedc9edfe
Version: 4
Effective Time: 20200728
 
Cadila Healthcare Limited