Tacrolimus (Page 7 of 7)

HOW SUPPLIED

Tacrolimus Capsules

strength 5 mg (containing the equivalent of 5 mg anhydrous tacrolimus)
shape/color Hard Gelatin Capsule Size 4, pink opaque body and cap
branding on capsule cap/body “WATSON” over “3359” on both cap and body printed in edible black ink.
30 count bottle NDC 0591-3359-30
100 count bottle NDC 0591-3359-01

Store and Dispense

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

Rx only

Manufactured by:
Watson Laboratories, Inc.
Corona, CA 92880 USA

Distributed by:
Watson Pharma, Inc.
Corona, CA 92880 USA

**IMx® is manufactured by and a registered trademark of Abbott Laboratories.

REFERENCE

1. CDC: Recommendations of the Advisory Committee on Immunization Practices: Use of vaccines and immune globulins in persons with altered immunocompetence. MMWR 1993;42(RR-4):1-18.

Revised: April 2010 194085

PRINCIPAL DISPLAY PANEL

NDC 0591-3359-01
Tacrolimus
Capsules
5 mgWatson® 100 Capsules Rx only

NDC 0591-3359-01 Tacrolimus Capsules 5 mg 100 Capsules Rx only
(click image for full-size original)
TACROLIMUS tacrolimus capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-3359
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TACROLIMUS (TACROLIMUS ANHYDROUS) TACROLIMUS ANHYDROUS 5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
MAGNESIUM STEARATE
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 1
FD&C RED NO. 3
FD&C RED NO. 40
Product Characteristics
Color PINK (opaque) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code WATSON;3359
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-3359-01 100 CAPSULE (100 CAPSULE) in 1 BOTTLE, PLASTIC None
2 NDC:0591-3359-30 30 CAPSULE (30 CAPSULE) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090402 07/06/2010
Labeler — Watson Laboratories, Inc. (966714656)
Establishment
Name Address ID/FEI Operations
AAIPharma Analytical Services 874223670 ANALYSIS (0591-3359)
Establishment
Name Address ID/FEI Operations
Celsis Analytical Services 151838182 ANALYSIS (0591-3359)
Establishment
Name Address ID/FEI Operations
Irvine Pharmaceutical Services, Inc. 627085608 ANALYSIS (0591-3359)
Establishment
Name Address ID/FEI Operations
Particle Technology Group 808076947 ANALYSIS (0591-3359)
Establishment
Name Address ID/FEI Operations
SGS Life Science Services 062491980 ANALYSIS (0591-3359)
Establishment
Name Address ID/FEI Operations
SGS Life Science Services 808308303 ANALYSIS (0591-3359)
Establishment
Name Address ID/FEI Operations
Watson Laboratories, Inc. 840054118 ANALYSIS (0591-3359), LABEL (0591-3359), MANUFACTURE (0591-3359), PACK (0591-3359)
Establishment
Name Address ID/FEI Operations
Whitehouse Analytical Laboratories 138628008 ANALYSIS (0591-3359)

Revised: 08/2012 Watson Laboratories, Inc.

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