Alosetron Hydrochloride (Page 7 of 7)

PRINCIPAL DISPLAY PANEL

NDC 53746-248-30

Alosetron tablets USP

0.5 mg

Rx only

300 Tablets

Amneal Pharmaceuticals LLC

1
(click image for full-size original)

NDC 53746-248-30

Alosetron tablets USP

1 mg

Rx only

30 Tablets

Amneal Pharmaceuticals LLC

1
(click image for full-size original)

ALOSETRON HYDROCHLORIDE alosetron hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53746-248
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALOSETRON HYDROCHLORIDE (ALOSETRON) ALOSETRON 0.5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
HYPROMELLOSES
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape OVAL Size 11mm
Flavor Imprint Code AN248
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53746-248-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206647 09/06/2023
ALOSETRON HYDROCHLORIDE alosetron hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53746-249
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALOSETRON HYDROCHLORIDE (ALOSETRON) ALOSETRON 1 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
FD&C BLUE NO. 2
HYPROMELLOSES
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TITANIUM DIOXIDE
Product Characteristics
Color blue (light blue) Score no score
Shape OVAL Size 11mm
Flavor Imprint Code AN249
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53746-249-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206647 09/06/2023
Labeler — Amneal Pharmaceuticals of New York LLC (123797875)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals Private Limited 650762060 analysis (53746-248), analysis (53746-249), label (53746-248), label (53746-249), manufacture (53746-248), manufacture (53746-249), pack (53746-248), pack (53746-249)

Revised: 03/2023 Amneal Pharmaceuticals of New York LLC

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