Prescription Drug Information: Midodrine Hydrochloride (Page 3 of 3)

HOW SUPPLIED

Midodrine Hydrochloride Tablets, USP are available containing 2.5 mg, 5 mg or 10 mg of midodrine hydrochloride, USP.

The 2.5 mg tablets are round, white scored tablet with C/149 on the upper side; and plain on the lower side. They are available as follows:

NDC 70700-157-01
Bottle of 100 Tablets

The 5 mg are tablets round, white scored tablet with C/150 on the upper side; and plain on the lower side. They are available as follows:

NDC 70700-158-01
Bottle of 100 Tablets

The 10 mg tablets are round, white scored tablet with C/151 on the upper side; and plain on the lower side. They are available as follows:

NDC 70700-159-01
Bottle of 100 Tablets

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

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

Manufactured for:
Xiromed, LLC.

Florham Park, NJ 07932

PI-159-00
Rev.: 07/2019

PRINCIPAL DISPLAY PANEL

NDC 70700-157-01

Midodrine Hydrochloride Tablets, USP 2.5 mg

Rx only 100 Tablets

midodrine2-5mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 70700-158-01

Midodrine Hydrochloride Tablets, USP 5 mg

Rx only 100 Tablets

midodrine-5mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 70700-159-01

Midodrine Hydrochloride Tablets, USP 10 mg

Rx only 100 Tablets

midodrine-10mg
(click image for full-size original)
MIDODRINE HYDROCHLORIDE
midodrine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70700-157
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MIDODRINE HYDROCHLORIDE (MIDODRINE) MIDODRINE HYDROCHLORIDE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
Product Characteristics
Color WHITE (white) Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code C;149
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70700-157-01 100 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207849 10/15/2020
MIDODRINE HYDROCHLORIDE
midodrine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70700-158
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MIDODRINE HYDROCHLORIDE (MIDODRINE) MIDODRINE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
Product Characteristics
Color WHITE (white) Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code C;150
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70700-158-01 100 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207849 10/15/2020
MIDODRINE HYDROCHLORIDE
midodrine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70700-159
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MIDODRINE HYDROCHLORIDE (MIDODRINE) MIDODRINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
Product Characteristics
Color WHITE (white) Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code C;151
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70700-159-01 100 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207849 10/15/2020
Labeler — Xiromed, LLC (080228637)
Registrant — Cerovene, Inc. (790387927)
Establishment
Name Address ID/FEI Operations
Cerovene, Inc. 790387927 analysis (70700-157), manufacture (70700-157), analysis (70700-158), manufacture (70700-158), analysis (70700-159), manufacture (70700-159)
Establishment
Name Address ID/FEI Operations
Nutra-Med Packaging Inc. 080274725 pack (70700-157), pack (70700-158), pack (70700-159)

Revised: 10/2020 Xiromed, LLC

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