NDC Code(s) : 42571-220-30, 42571-220-05, 42571-220-10, 42571-221-30, 42571-221-05, 42571-221-10
Packager : Micro Labs Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

RASAGILINE Rasagiline TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42571-220
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RASAGILINE MESYLATE(UNII: LH8C2JI290)
(RASAGILINE - UNII:003N66TS6T) 		RASAGILINE0.5 mg
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
STEARIC ACID(UNII: 4ELV7Z65AP)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color white (off white) Score no score
Shape ROUND (flat faced beveled edge) Size 6 mm
Flavor Imprint Code 0;5
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42571-220-3030 in 1 BOTTLE Type 0: Not a Combination Product04/03/2019
2NDC:42571-220-05500 in 1 BOTTLE Type 0: Not a Combination Product04/03/2019
3NDC:42571-220-101000 in 1 BOTTLE Type 0: Not a Combination Product04/03/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207004 04/03/2019
RASAGILINE Rasagiline TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42571-221
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RASAGILINE MESYLATE(UNII: LH8C2JI290)
(RASAGILINE - UNII:003N66TS6T) 		RASAGILINE1 mg
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
STEARIC ACID(UNII: 4ELV7Z65AP)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color white (off white) Score no score
Shape ROUND (flat faced beveled edge) Size 8 mm
Flavor Imprint Code 1
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42571-221-3030 in 1 BOTTLE Type 0: Not a Combination Product04/03/2019
2NDC:42571-221-05500 in 1 BOTTLE Type 0: Not a Combination Product04/03/2019
3NDC:42571-221-101000 in 1 BOTTLE Type 0: Not a Combination Product04/03/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207004 04/03/2019

LABELER - Micro Labs Limited(862174955)

Establishment
Name Address ID/FEI Business Operations
Micro Labs Limited 915793658 analysis(42571-220, 42571-221), label(42571-220, 42571-221), manufacture(42571-220, 42571-221), pack(42571-220, 42571-221)

PRINCIPAL DISPLAY PANEL

NDC 42571-220-30
Rasagiline Tablets
0.5 mg
Rx Only
30 Tablets
MICRO LABS LIMITED

rasagiline-lbl-a.jpg

NDC 42571-221-30
Rasagiline Tablets
1 mg
Rx Only
30 Tablets
MICRO LABS LIMITED

rasagiline-lbl-a.jpg