Leucovorin Calcium (Page 2 of 2)

HOW SUPPLIED:

Leucovorin Calcium Tablets USP, 5 mg are available as white, round, unscored, biconvex tablets, debossed with b on one side and 484 on the other side. They are available as follows:

NDC 51079-581-06 — Unit dose blister packages of 50 (5 cards of 10 tablets each).

Leucovorin Calcium Tablets USP, 25 mg are available as pale green, round, unscored, biconvex tablets, debossed with b on one side and 485 on the other side. They are available as follows:

NDC 51079-582-05 – Unit dose blister packages of 20 (2 cards of 10 tablets each).

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

REFERENCES

  1. Grem JL, Shoemaker DD, Petrelli NJ, Douglas HO. Severe and fatal toxic effects observed in treatment with high- and low-dose leucovorin plus 5-fluorouracil for colorectal carcinoma. Cancer Treat Rep 1987;71:1122.
  2. Link MP, Goorin AM, Miser AW et al. The effect of adjuvant chemotherapy on relapse-free survival in patients with osteosarcoma of the extremity. N Engl J Med 1986;314:1600-1606.

Manufactured by:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454

Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103

S-12078 R1
7/17

PRINCIPAL DISPLAY PANEL – 5 mg

NDC 51079-581-06

Leucovorin Calcium
Tablets, USP
5 mg*

50 Tablets (5 x 10)

*Each tablet contains leucovorin
calcium, USP equivalent to 5 mg leucovorin.

Usual Dosage: See accompanying
prescribing information.

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

Manufactured by:
Teva Pharmaceuticals USA, Inc. North Wales, PA 19454

Rx only

S-10767 R3

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Leucovorin Calcium 5 mg Tablets Unit Carton Label
(click image for full-size original)
Serialized Unit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – 25 mg

NDC 51079-582-05

Leucovorin Calcium
Tablets USP
25 mg*

20 Tablets (2 x 10)

*Each tablet contains leucovorin
calcium, USP equivalent to 25 mg leucovorin.

Usual Dosage: See accompanying
prescribing information.

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

Manufactured by:
Teva Pharmaceuticals USA, Inc. North Wales, PA 19454

Rx only

S-10768 R3

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Leucovorin Calcium Tablets Unit Carton Label
(click image for full-size original)
Serialized Unit Carton
(click image for full-size original)
LEUCOVORIN CALCIUM leucovorin calcium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-581(NDC:0555-0484)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEUCOVORIN CALCIUM (LEUCOVORIN) LEUCOVORIN 5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color white Score no score
Shape ROUND Size 8mm
Flavor Imprint Code b;484
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-581-06 50 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-581-01)
1 NDC:51079-581-01 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (51079-581-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071198 02/26/1996
LEUCOVORIN CALCIUM leucovorin calcium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-582(NDC:0555-0485)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEUCOVORIN CALCIUM (LEUCOVORIN) LEUCOVORIN 25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
Product Characteristics
Color green (pale green) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code b;485
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-582-05 20 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-582-01)
1 NDC:51079-582-01 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (51079-582-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071199 08/27/1997
Labeler — Mylan Institutional Inc. (039615992)

Revised: 12/2018 Mylan Institutional Inc.

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