Sumatriptan: Package Insert and Label Information (Page 4 of 4)

Rx only

OrchidPharma

NDC 42043-220 -09

Sumatriptan

Tablets, USP

25 mg

PHARMACIST: Dispense the patient information leaflet with the drug product.

9 film-coated tablets

1 Blister of 9 Tablets

25 mg Label
(click image for full-size original)

Rx only

OrchidPharma

NDC 42043-221 -09

Sumatriptan

Tablets, USP

50 mg

PHARMACIST: Dispense the patient information leaflet with the drug product.

9 film-coated tablets

1 Blister of 9 Tablets

50 mg Label
(click image for full-size original)

Rx only

OrchidPharma

NDC 42043-222 -09

Sumatriptan

Tablets, USP

100 mg

PHARMACIST: Dispense the patient information leaflet with the drug product.

9 film-coated tablets

1 Blister of 9 Tablets

100 mg Label
(click image for full-size original)
SUMATRIPTAN sumatriptan tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42043-220
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUMATRIPTAN SUCCINATE (SUMATRIPTAN) SUMATRIPTAN 25 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM BICARBONATE
HYPROMELLOSE 2910 (3 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 6000
FERRIC OXIDE YELLOW
POLYSORBATE 80
Product Characteristics
Color yellow Score no score
Shape TRIANGLE (triangular biconvex) Size 7mm
Flavor Imprint Code S;102
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42043-220-09 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK (42043-220-00)
1 NDC:42043-220-00 9 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (42043-220-09)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078284 03/04/2020
SUMATRIPTAN sumatriptan tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42043-221
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUMATRIPTAN SUCCINATE (SUMATRIPTAN) SUMATRIPTAN 50 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM BICARBONATE
HYPROMELLOSE 2910 (3 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
FERRIC OXIDE RED
Product Characteristics
Color pink Score no score
Shape TRIANGLE (triangular biconvex) Size 8mm
Flavor Imprint Code S;103
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42043-221-09 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK (42043-221-00)
1 NDC:42043-221-00 9 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (42043-221-09)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078284 03/04/2020
SUMATRIPTAN sumatriptan tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42043-222
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUMATRIPTAN SUCCINATE (SUMATRIPTAN) SUMATRIPTAN 100 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM BICARBONATE
HYPROMELLOSE 2910 (5 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
Product Characteristics
Color white (white to off white) Score no score
Shape TRIANGLE (triangular biconvex) Size 10mm
Flavor Imprint Code S;104
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42043-222-09 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK (42043-222-00)
1 NDC:42043-222-00 9 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (42043-222-09)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078284 03/04/2020
Labeler — OrchidPharma Inc (809429207)
Registrant — Orchid Pharma Ltd. (650133507)
Establishment
Name Address ID/FEI Operations
Orchid Helathcare (A Division of Orchid Pharma Limited) 650288850 analysis (42043-220), manufacture (42043-220), pack (42043-220), label (42043-220), analysis (42043-221), manufacture (42043-221), pack (42043-221), label (42043-221), analysis (42043-222), manufacture (42043-222), pack (42043-222), label (42043-222)

Revised: 01/2022 OrchidPharma Inc

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