Clonidine Hydrochloride (Page 3 of 3)

HOW SUPPLIED

Clonidine Hydrochloride Tablets, USP are supplied as:

0.1 mg

White round shaped, biconvex, scored tablets, debossed with “U” and “135” on either side of breakline on one side and plain on other side.

Bottles of 100: NDC 29300-468-01

Bottles of 500: NDC 29300-468-05

Bottles of 1,000: NDC 29300-468-10

Bottles of 5,000: NDC 29300-468-50

0.2 mg

White rounded off oval shaped, biconvex tablets, with score line having “U” and “136” debossed across the score line on one side and plain on other side.

Bottles of 100: NDC 29300-136-01

Bottles of 500: NDC 29300-136-05

Bottles of 1,000: NDC 29300-136-10

Bottles of 5,000: NDC 29300-136-50

0.3 mg

White rounded off oval shaped, biconvex tablets with score line having “U” and “137” debossed across the score line on one side and plain on other side.

Bottles of 100: NDC 29300-137-01

Bottles of 500: NDC 29300-137-05

Bottles of 1,000: NDC 29300-137-10

Bottles of 2,500: NDC 29300-137-25

Store at 20^o to 25^o C (68^o to 77^o F) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container.

Please address medical inquiries to Unichem’s toll free # 1-866-562-4616.

Manufactured by:

UNICHEM LABORATORIES LTD.

Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India

Manufactured for:

East Brunswick, NJ 08816

07-R-08/2020

13012905

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLONIDINE HYDROCHLORIDE clonidine hydrochloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29300-468 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLONIDINE HYDROCHLORIDE (CLONIDINE) CLONIDINE HYDROCHLORIDE 0.1 mg

Inactive Ingredients Ingredient Name Strength DIBASIC CALCIUM PHOSPHATE DIHYDRATE GLYCERIN LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE, UNSPECIFIED SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN

Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code U;135 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:29300-468-05 500 TABLET in 1 BOTTLE, PLASTIC None 2 NDC:29300-468-10 1000 TABLET in 1 BOTTLE, PLASTIC None 3 NDC:29300-468-50 5000 TABLET in 1 BOTTLE, PLASTIC None 4 NDC:29300-468-01 100 TABLET in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078895 12/24/2020

CLONIDINE HYDROCHLORIDE clonidine hydrochloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29300-136 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLONIDINE HYDROCHLORIDE (CLONIDINE) CLONIDINE HYDROCHLORIDE 0.2 mg

Inactive Ingredients Ingredient Name Strength DIBASIC CALCIUM PHOSPHATE DIHYDRATE GLYCERIN LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE, UNSPECIFIED SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN

Product Characteristics Color WHITE Score 2 pieces Shape OVAL Size 8mm Flavor Imprint Code U;136 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:29300-136-01 100 TABLET in 1 BOTTLE, PLASTIC None 2 NDC:29300-136-05 500 TABLET in 1 BOTTLE, PLASTIC None 3 NDC:29300-136-10 1000 TABLET in 1 BOTTLE, PLASTIC None 4 NDC:29300-136-50 5000 TABLET in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078895 09/21/2009

CLONIDINE HYDROCHLORIDE clonidine hydrochloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29300-137 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLONIDINE HYDROCHLORIDE (CLONIDINE) CLONIDINE HYDROCHLORIDE 0.3 mg

Inactive Ingredients Ingredient Name Strength DIBASIC CALCIUM PHOSPHATE DIHYDRATE GLYCERIN LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE, UNSPECIFIED SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN

Product Characteristics Color WHITE Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code U;137 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:29300-137-01 100 TABLET in 1 BOTTLE, PLASTIC None 2 NDC:29300-137-05 500 TABLET in 1 BOTTLE, PLASTIC None 3 NDC:29300-137-10 1000 TABLET in 1 BOTTLE, PLASTIC None 4 NDC:29300-137-25 2500 TABLET in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078895 09/21/2009

CLONIDINE HYDROCHLORIDE clonidine hydrochloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29300-135 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLONIDINE HYDROCHLORIDE (CLONIDINE) CLONIDINE HYDROCHLORIDE 0.1 mg

Inactive Ingredients Ingredient Name Strength DIBASIC CALCIUM PHOSPHATE DIHYDRATE GLYCERIN LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE, UNSPECIFIED SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN

Product Characteristics Color WHITE Score 2 pieces Shape OVAL Size 8mm Flavor Imprint Code U;135 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:29300-135-01 100 TABLET in 1 BOTTLE, PLASTIC None 2 NDC:29300-135-05 500 TABLET in 1 BOTTLE, PLASTIC None 3 NDC:29300-135-10 1000 TABLET in 1 BOTTLE, PLASTIC None 4 NDC:29300-135-50 5000 TABLET in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078895 09/21/2009

Labeler — Unichem Pharmaceuticals (USA), Inc. (181620514)

Revised: 12/2020 Unichem Pharmaceuticals (USA), Inc.