NDC Code(s) : 13668-482-01, 13668-483-01, 13668-484-50, 13668-484-05
Packager : Torrent Pharmaceuticals Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Minocycline HydrochlorideMinocycline Hydrochloride CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-482
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MINOCYCLINE HYDROCHLORIDE(UNII: 0020414E5U)
(MINOCYCLINE - UNII:FYY3R43WGO) 		MINOCYCLINE50 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
GELATIN(UNII: 2G86QN327L)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
STARCH, CORN(UNII: O8232NY3SJ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white (to off-white, opaque) Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code RX694
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13668-482-01100 in 1 BOTTLE Type 0: Not a Combination Product04/02/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065062 04/02/2015
Minocycline HydrochlorideMinocycline Hydrochloride CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-483
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MINOCYCLINE HYDROCHLORIDE(UNII: 0020414E5U)
(MINOCYCLINE - UNII:FYY3R43WGO) 		MINOCYCLINE75 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
GELATIN(UNII: 2G86QN327L)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
STARCH, CORN(UNII: O8232NY3SJ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color gray (opaque) Score no score
Shape CAPSULE Size 16 mm
Flavor Imprint Code RX695
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13668-483-01100 in 1 BOTTLE Type 0: Not a Combination Product04/02/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065062 04/02/2015
Minocycline HydrochlorideMinocycline Hydrochloride CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-484
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MINOCYCLINE HYDROCHLORIDE(UNII: 0020414E5U)
(MINOCYCLINE - UNII:FYY3R43WGO) 		MINOCYCLINE100 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
GELATIN(UNII: 2G86QN327L)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
STARCH, CORN(UNII: O8232NY3SJ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color gray (gray opaque cap, white opaque body) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code RX696
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13668-484-5050 in 1 BOTTLE Type 0: Not a Combination Product04/02/2015
2NDC:13668-484-05500 in 1 BOTTLE Type 0: Not a Combination Product04/02/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065062 04/02/2015

LABELER - Torrent Pharmaceuticals Limited(916488547)

REGISTRANT - Torrent Pharma, Inc.(790033935)

Establishment
Name Address ID/FEI Business Operations
Ohm Laboratories 051565745 manufacture(13668-482, 13668-483, 13668-484), analysis(13668-482, 13668-483, 13668-484), pack(13668-482, 13668-483, 13668-484)

Establishment
Name Address ID/FEI Business Operations
Torrent Pharmaceuticals Limited 864147745 analysis(13668-482, 13668-483, 13668-484), pack(13668-482, 13668-483, 13668-484), manufacture(13668-482, 13668-483, 13668-484), api manufacture(13668-482, 13668-483, 13668-484)

PRINCIPAL DISPLAY PANEL

Minocycline HCl Capsules 50 mg, 100 capsules

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Minocycline HCl Capsules 75 mg, 100 capsules

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Minocycline HCl Capsules 100 mg, 50 capsules

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