Mirtazapine (Page 9 of 9)

PRINCIPAL DISPLAY PANEL — 15 mg

NDC 0378-3515-93

Mirtazapine
Tablets, USP
15 mg

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

Rx only 30 Tablets

Each film-coated tablet contains:
Mirtazapine, USP 15 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Protect from light and moisture.

Usual Dosage: See accompanying
prescribing information.

Manufactured for:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Made in Australia

Mylan.com

RALP3515H2

2827/2

Mirtazapine Tablets 15 mg Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 30 mg

NDC 0378-3530-93

Mirtazapine
Tablets, USP
30 mg

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

Rx only 30 Tablets

Each film-coated tablet contains:
Mirtazapine, USP 30 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Protect from light and moisture.

Usual Dosage: See accompanying
prescribing information.

Manufactured for:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Made in Australia

Mylan.com

RALP3530H2

2829/2

Mirtazapine Tablets 30 mg Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 45 mg

NDC 0378-3545-93

Mirtazapine
Tablets, USP
45 mg

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

Rx only 30 Tablets

Each film-coated tablet contains:
Mirtazapine, USP 45 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Protect from light and moisture.

Usual Dosage: See accompanying
prescribing information.

Manufactured for:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Made in Australia

Mylan.com

RALP3545H10

2831/2

Mirtazapine Tablets 45 mg Bottle Label
(click image for full-size original)
MIRTAZAPINE mirtazapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-3515
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MIRTAZAPINE (MIRTAZAPINE) MIRTAZAPINE 15 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
FD&C YELLOW NO. 6
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 102
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
STARCH, CORN
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color BROWN (beige) Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code M;515
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-3515-70 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:0378-3515-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:0378-3515-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
4 NDC:0378-3515-10 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076122 06/20/2003
MIRTAZAPINE mirtazapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-3530
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MIRTAZAPINE (MIRTAZAPINE) MIRTAZAPINE 30 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
FD&C YELLOW NO. 6
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 102
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
STARCH, CORN
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color BROWN (beige) Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code M;530
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-3530-70 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:0378-3530-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:0378-3530-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
4 NDC:0378-3530-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076122 06/20/2003
MIRTAZAPINE mirtazapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-3545
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MIRTAZAPINE (MIRTAZAPINE) MIRTAZAPINE 45 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
FD&C YELLOW NO. 6
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 102
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
STARCH, CORN
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color BROWN (beige) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code M;545
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-3545-70 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:0378-3545-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:0378-3545-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
4 NDC:0378-3545-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076122 06/20/2003
Labeler — Mylan Pharmaceuticals Inc. (059295980)

Revised: 10/2022 Mylan Pharmaceuticals Inc.

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