Clonidine Hydrochloride (Page 3 of 3)

HOW SUPPLIED

Clonidine Hydrochloride Tablets, USP are supplied as:

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 60: NDC 51655-339-25

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:

Company Logo

East Brunswick, NJ 08816

07-R-08/2020

13012905

Principal Display Panel

NDC: 51655-339-25

Label Image
(click image for full-size original)
CLONIDINE HYDROCHLORIDE
clonidine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-339(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:51655-339-25 60 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078895 05/27/2020
Labeler — Northwind Pharmaceuticals, LLC (036986393)
Registrant — Northwind Pharmaceuticals, LLC (036986393)
Establishment
Name Address ID/FEI Operations
Northwind Pharmaceuticals, LLC 036986393 repack (51655-339)

Revised: 10/2023 Northwind Pharmaceuticals, LLC

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