LEUCOVORIN CALCIUM (Page 2 of 2)

HOW SUPPLIED

Leucovorin Calcium Tablets USP

5 mg tablets are supplied as a white to off-white to pale yellow, round tablet; scored on one side and “LP” over “184” debossed on the other side; bottles of 30 (NDC 69315-184-03) and 100 (NDC 69315-184-01).

10 mg tablets are supplied as a white to off-white to pale yellow, round tablet; scored on one side and “LP” over “185” debossed on the other side; bottles of 12 (NDC 69315-185-12) and 24 (NDC 69315-185-24).

15 mg tablets are supplied as a white to off-white to pale yellow, round tablet; scored on one side and “LP” over ” 186″ debossed on the other side; bottles of 24 (NDC 69315-186-24).

25 mg tablets are supplied as a white to off-white to pale yellow, round tablet; scored on one side and “LP” over ” 187″ debossed on the other side; bottles of 25 (NDC 69315-187-25).

Store at 15° to 25°C (59° to 77°F). Protect from light and moisture.

REFERENCES

  1. Grem JL, Shoemaker DD, Petrelli NJ, Douglas HO Jr. 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.

Rx only

Manufactured and Distributed by:

Leading Pharma, LLC

Fairfield, NJ 07004, USA

Rev.02 11/21

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

container5mg30cc
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container5mg100cc
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container10mg12cc
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container10mg24cc
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container15mg24cc
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container25mg25cc
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LEUCOVORIN CALCIUM
leucovorin calcium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69315-184
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
MAGNESIUM STEARATE
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color white (White to off-white to pale yellow) Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code LP;184
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69315-184-03 30 TABLET in 1 BOTTLE None
2 NDC:69315-184-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213929 11/16/2020
LEUCOVORIN CALCIUM
leucovorin calcium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69315-185
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEUCOVORIN CALCIUM (LEUCOVORIN) LEUCOVORIN 10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color white (White to off-white to pale yellow) Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code LP;185
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69315-185-12 12 TABLET in 1 BOTTLE None
2 NDC:69315-185-24 24 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213929 11/16/2020
LEUCOVORIN CALCIUM
leucovorin calcium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69315-186
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEUCOVORIN CALCIUM (LEUCOVORIN) LEUCOVORIN 15 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color white (White to off-white to pale yellow) Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code LP;186
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69315-186-24 24 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213929 11/16/2020
LEUCOVORIN CALCIUM
leucovorin calcium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69315-187
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
MAGNESIUM STEARATE
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color white (White to off-white to pale yellow) Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code LP;187
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69315-187-25 25 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213929 11/16/2020
Labeler — Leading Pharma, LLC (079575060)
Establishment
Name Address ID/FEI Operations
Leading Pharma, LLC 079575060 MANUFACTURE (69315-184) (69315-166) (69315-165), MANUFACTURE (69315-185) (69315-166) (69315-165), MANUFACTURE (69315-186) (69315-166) (69315-165), MANUFACTURE (69315-187) (69315-166) (69315-165)

Revised: 11/2021 Leading Pharma, LLC

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