Pilocarpine Hydrochloride (Page 4 of 4)

HOW SUPPLIED

Pilocarpine Hydrochloride Tablets, USP 5 mg are off white to white colour, biconvex round shaped film-coated tablet debossed with “PIL” on one side and “5” on the other side. Each tablet contains 5 mg pilocarpine hydrochloride USP. They are supplied as follows:

Bottles of 100 NDC 16714-121-01

Pilocarpine Hydrochloride Tablets, USP 7.5 mg are light blue to blue colour, biconvex round shaped film-coated tablet debossed with “PIL” on one side and “7.5” on the other side. Each tablet contains 7.5 mg pilocarpine hydrochloride USP. They are supplied as follows:

Bottles of 100 NDC 16714-122-01

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

Manufactured for:
Northstar Rx LLC
Memphis, TN 38141.
Toll number : 1-800-206-7821
Manufactured by:
APL Healthcare Limited
Unit-IV (MP SEZ),
SPSR Nellore (Dt)-524 421
Andhra Pradesh, India.
M.L.No.: 04/NLR/AP/2016/F/CC


Revised: 04/2021

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 5 mg (100 Tablets Bottle)

Rx only
NDC 16714-121-01

Pilocarpine Hydrochloride

Tablets, USP

5 mg
100 Tablets
NorthStarX ®

PACKAGE LABEL -- PRINCIPAL DISPLAY PANEL -- 5 mg (100 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 7.5 mg (100 Tablets Bottle)

Rx only
NDC 16714-122-01

Pilocarpine Hydrochloride

Tablets, USP

7.5 mg
100 Tablets
NorthStarX ®

PACKAGE LABEL -- PRINCIPAL DISPLAY PANEL -- 7.5 mg (100 Tablets Bottle)
(click image for full-size original)

PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-121
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PILOCARPINE HYDROCHLORIDE (PILOCARPINE) PILOCARPINE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2910 (6 MPA.S)
MICROCRYSTALLINE CELLULOSE 102
POLYETHYLENE GLYCOL 400
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (off White to White) Score no score
Shape ROUND (Biconvex) Size 6mm
Flavor Imprint Code PIL;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-121-01 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212377 08/13/2019
PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-122
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PILOCARPINE HYDROCHLORIDE (PILOCARPINE) PILOCARPINE HYDROCHLORIDE 7.5 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 2
HYPROMELLOSE 2910 (6 MPA.S)
MICROCRYSTALLINE CELLULOSE 102
POLYETHYLENE GLYCOL 400
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color BLUE (Light Blue to Blue) Score no score
Shape ROUND (Biconvex) Size 7mm
Flavor Imprint Code PIL;7;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-122-01 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212377 08/13/2019
Labeler — NorthStar Rx LLC (830546433)
Registrant — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
APL HEALTHCARE LIMITED 650918514 ANALYSIS (16714-121), ANALYSIS (16714-122), MANUFACTURE (16714-121), MANUFACTURE (16714-122)

Revised: 05/2021 NorthStar Rx LLC

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