Griseofulvin (Page 3 of 3)

HOW SUPPLIED

Griseofulvin tablets, USP (microsize) are available as follows:

250 mg, white to off-white round, flat, beveled edge, scored tablets engraved with ‘I27’ on one side and score on the other.

NDC 0781-5514-01, in bottles of 100 tablets
NDC 0781-5514-05, in bottles of 500 tablets

500 mg, white to off-white round, flat, beveled edge, scored tablets engraved with ‘I26’ on one side and score on the other.

NDC 0781-5515-01, in bottles of 100 tablets
NDC 0781-5515-05, in bottles of 500 tablets

Dispense griseofulvin tablets, USP (microsize) in a tight container as defined in the USP.

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

Manufactured by

USV Private Limited,

Mahatma Gandhi Udyog Nagar,

Dabhel, Daman 396210, India

for Sandoz Inc.,

Princeton, NJ 08540

Rev. December 2016

PRINCIPAL DISPLAY PANEL

NDC 0781-5514-01

Griseofulvin Tablets, USP (Microsize)

250 mg

Pharmacist: Do not use if foil seal is removed or damaged. Return to the place of purchase.

250 mg
(click image for full-size original)

Principal Display Panel

NDC 0781-5515-01

Griseofulvin Tablets, USP (Microsize)

500 mg

Pharmacist: Do not use if foil seal is removed or damaged. Return to the place of purchase.

500 mg
(click image for full-size original)

GRISEOFULVIN
griseofulvin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-5514
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GRISEOFULVIN (GRISEOFULVIN) GRISEOFULVIN 250 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE
SILICON DIOXIDE
STARCH, CORN
CROSPOVIDONE (15 MPA.S AT 5%)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code I27
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0781-5514-01 100 TABLET in 1 BOTTLE None
2 NDC:0781-5514-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091592 08/07/2013
GRISEOFULVIN
griseofulvin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-5515
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GRISEOFULVIN (GRISEOFULVIN) GRISEOFULVIN 500 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE
SILICON DIOXIDE
STARCH, CORN
CROSPOVIDONE (15 MPA.S AT 5%)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape ROUND Size 13mm
Flavor Imprint Code I26
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0781-5515-01 100 TABLET in 1 BOTTLE None
2 NDC:0781-5515-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091592 08/07/2013
Labeler — Sandoz Inc (005387188)

Revised: 12/2016 Sandoz Inc

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