Tacrolimus (Page 9 of 9)

Manufactured For:

Accord Healthcare, Inc.,

1009, Slater Road,
Suite 210-B,
Durham, NC 27703,
USA.

Manufactured By:

Intas Pharmaceuticals Limited,
Plot No : 457, 458,
Village – Matoda,
Bavla Road, Ta.- Sanand,
Dist.- Ahmedabad – 382 210.
India.

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.

10 2711 0 610122

Issued May 2011

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

tacrolimus, 0.5 mg — Container Label

NDC 16729-041 -01

Tacrolimus
Capsules 0.5 mg

Rx Only

100 Capsules

a ccord

0.5mg
(click image for full-size original)

tacrolimus, 1 mg — Container Label

NDC 16729-042 -01

Tacrolimus Capsules 1 mg

Rx Only

100 Capsules

a ccord

1mgContainer
(click image for full-size original)

tacrolimus, 5 mg — Container Label

NDC 16729-043 -01

Tacrolimus Capsules 5 mg

Rx Only

100 Capsules

a ccord

5mgContainer
(click image for full-size original)
TACROLIMUS tacrolimus capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-041
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
tacrolimus (TACROLIMUS ANHYDROUS) tacrolimus 0.5 mg
Inactive Ingredients
Ingredient Name Strength
croscarmellose sodium
lactose monohydrate
magnesium stearate
HYPROMELLOSES
GELATIN
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
SODIUM LAURYL SULFATE
Product Characteristics
Color YELLOW (LIGHT YELLOW) Score no score
Shape CAPSULE Size 11mm
Flavor Imprint Code TCR;05
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-041-01 100 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091195 06/15/2011
TACROLIMUS tacrolimus capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-042
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
tacrolimus (TACROLIMUS ANHYDROUS) tacrolimus 1 mg
Inactive Ingredients
Ingredient Name Strength
croscarmellose sodium
lactose monohydrate
magnesium stearate
HYPROMELLOSES
GELATIN
TITANIUM DIOXIDE
SODIUM LAURYL SULFATE
Product Characteristics
Color WHITE (WHITE) Score no score
Shape CAPSULE Size 11mm
Flavor Imprint Code TCR;1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-042-01 100 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091195 06/15/2011
TACROLIMUS tacrolimus capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-043
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
tacrolimus (TACROLIMUS ANHYDROUS) tacrolimus 5 mg
Inactive Ingredients
Ingredient Name Strength
croscarmellose sodium
lactose monohydrate
magnesium stearate
HYPROMELLOSES
GELATIN
TITANIUM DIOXIDE
FERRIC OXIDE RED
SODIUM LAURYL SULFATE
Product Characteristics
Color PINK (PINK) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code TCR;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-043-01 100 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091195 06/15/2011
Labeler — Accord Heathcare, Inc. (604222237)
Establishment
Name Address ID/FEI Operations
Intas Pharmaceuticals Limited 725927649 MANUFACTURE (16729-041) (16729-042) (16729-043)

Revised: 08/2012 Accord Heathcare, Inc.

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