Minocycline Hydrochloride (Page 5 of 5)

Minocycline Hydrochloride Capsules, USP 50 mg, 100 Caps Label

50 mg
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Minocycline Hydrochloride Capsules, USP 75 mg, 100 Caps Label

75 mg
(click image for full-size original)

Minocycline Hydrochloride Capsules, USP 100 mg, 100 Caps Label

100 mg
(click image for full-size original)
MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57664-851
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE) MINOCYCLINE 50 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
SHELLAC
D&C RED NO. 33
FD&C RED NO. 3
FD&C YELLOW NO. 6
SILICON DIOXIDE
Product Characteristics
Color PINK (Flesh Opaque) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code 851
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57664-851-88 100 CAPSULE in 1 BOTTLE None
2 NDC:57664-851-13 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090867 05/13/2013
MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57664-852
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE) MINOCYCLINE 75 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
GELATIN, UNSPECIFIED
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
FERROSOFERRIC OXIDE
SHELLAC
SILICON DIOXIDE
TITANIUM DIOXIDE
PROPYLENE GLYCOL
Product Characteristics
Color GRAY (Gray Opaque) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code 852
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57664-852-88 100 CAPSULE in 1 BOTTLE None
2 NDC:57664-852-13 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090867 05/13/2013
MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57664-853
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE) MINOCYCLINE 100 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
SHELLAC
D&C RED NO. 28
FERRIC OXIDE RED
SILICON DIOXIDE
Product Characteristics
Color RED (Maroon Opaque) , PINK (Flesh Opaque) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 853
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57664-853-85 50 CAPSULE in 1 BOTTLE None
2 NDC:57664-853-13 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090867 05/13/2013
Labeler — Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
Name Address ID/FEI Operations
Sidmak Laboratories (India) Pvt.Ltd. 677604490 ANALYSIS (57664-851), ANALYSIS (57664-852), ANALYSIS (57664-853), MANUFACTURE (57664-851), MANUFACTURE (57664-852), MANUFACTURE (57664-853), PACK (57664-851), PACK (57664-852), PACK (57664-853)

Revised: 05/2018 Sun Pharmaceutical Industries, Inc.

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