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Minocycline Prescribing Information

Package insert / product label
Generic name: Minocycline hydrochloride
Dosage form: capsule
Drug class: Tetracyclines

Medically reviewed by Drugs.com. Last updated on Nov 1, 2022.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1426-1

Minocycline Hydrochloride Capsules USP, 50 mg

100 Capsules

Rx only

NDC 70771-1427-1

Minocycline Hydrochloride Capsules USP, 75 mg

100 Capsules

Rx only

NDC 70771-1428-7

Minocycline Hydrochloride Capsules USP, 100 mg

50 Capsules

Rx only

Minocycline HYDROCHLORIDE
Minocycline hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:70771-1426
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
STARCH, CORN
MAGNESIUM STEARATE
GELATIN
TITANIUM DIOXIDE
D&C RED NO. 33
FD&C RED NO. 3
FD&C YELLOW NO. 6
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
SHELLAC
AMMONIA
ALUMINUM OXIDE
Product Characteristics
Color PINK (pink body and cap) Score no score
Shape CAPSULE (CAPSULE) Size 16mm
Flavor Imprint Code 316
Contains
Packaging
# Item Code Package Description
1 NDC:70771-1426-1 100 CAPSULE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA063011 04/03/2017
Minocycline HYDROCHLORIDE
Minocycline hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:70771-1427
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
ALUMINUM OXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
FERROSOFERRIC OXIDE
GELATIN
MAGNESIUM STEARATE
PROPYLENE GLYCOL
SHELLAC
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color GRAY (light gray opaque body and white opaque cap) Score no score
Shape CAPSULE (CAPSULE) Size 16mm
Flavor Imprint Code 317
Contains
Packaging
# Item Code Package Description
1 NDC:70771-1427-1 100 CAPSULE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA063009 04/03/2017
Minocycline HYDROCHLORIDE
Minocycline hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:70771-1428
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
ALUMINUM OXIDE
AMMONIA
D&C RED NO. 28
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
GELATIN
MAGNESIUM STEARATE
PROPYLENE GLYCOL
SHELLAC
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color PINK (pink body and maroon cap) Score no score
Shape CAPSULE (CAPSULE) Size 18mm
Flavor Imprint Code 318
Contains
Packaging
# Item Code Package Description
1 NDC:70771-1428-7 50 CAPSULE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA063009 04/03/2017
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (863362789)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1426, 70771-1427, 70771-1428), MANUFACTURE(70771-1426, 70771-1427, 70771-1428)
Zydus Lifesciences Limited

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