Midodrine Hydrochloride (Page 4 of 4)

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL – 2.5 MG LABEL

AvKARE
NDC 42291-560-90
Midodrine Hydrochloride Tablets, USP
2.5 mg
90 Tablets
Rx Only

Each tablet contains 2.5 mg of midodrine hydrochloride.
Usual Dosage: See package insert.
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Keep out of the reach of children.
Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
Mfg. Rev. 319049 AV 05/17 (P)
N3 42291 56090 1

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL – 5 MG LABEL

AvKARE
NDC 42291-561-90
Midodrine Hydrochloride Tablets, USP
5 mg
90 Tablets
Rx Only
Each tablet contains 5mg of midodrine hydrochloride.
Usual Dosage: See package insert.
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Keep out of the reach of children.
Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
Mfg. Rev. 319053 AV 05/17 (P)
N3 42291 56190 8

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL – 10 MG LABEL

AvKARE
NDC 42291-562-90
Midodrine Hydrochloride Tablets, USP
10 mg
90 Tablets
Rx Only
Each tablet contains 10 mg of midodrine hydrochloride.
Usual Dosage: See package insert.
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Keep out of the reach of children.
Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
Mfg. Rev. 319057 AV 05/17 (P)
N3 42291 56290 5

MIDODRINE HYDROCHLORIDE midodrine hydrochloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-560(NDC:60505-1320) 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 SILICON DIOXIDE STARCH, CORN MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE

Product Characteristics Color white Score 2 pieces Shape ROUND Size 6mm Flavor Imprint Code APO;MID;2;5 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42291-560-90 90 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077746 05/05/2017

MIDODRINE HYDROCHLORIDE midodrine hydrochloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-561(NDC:60505-1321) 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 SILICON DIOXIDE STARCH, CORN MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE FD&C YELLOW NO. 6

Product Characteristics Color orange Score 2 pieces Shape ROUND Size 7mm Flavor Imprint Code APO;MID;5 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42291-561-90 90 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077746 05/05/2017

MIDODRINE HYDROCHLORIDE midodrine hydrochloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-562(NDC:60505-1325) 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 SILICON DIOXIDE STARCH, CORN MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE FD&C BLUE NO. 1

Product Characteristics Color blue (Light blue) Score 2 pieces Shape ROUND Size 7mm Flavor Imprint Code APO;MID;10 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42291-562-90 90 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077746 05/05/2017

Labeler — AvKARE (796560394)

Revised: 01/2022 AvKARE