Tolvaptan (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tolvaptan Tablets 30 mg — carton label

tolvpcarton
(click image for full-size original)

Tolvaptan Tablets 15 mg — carton label

tolvpcarton15mg
(click image for full-size original)
TOLVAPTAN tolvaptan tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-869
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOLVAPTAN (TOLVAPTAN) TOLVAPTAN 30 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
MAGNESIUM STEARATE
METHYL ALCOHOL
METHYLENE CHLORIDE
MICROCRYSTALLINE CELLULOSE 102
POVIDONE K30
LACTOSE MONOHYDRATE
Product Characteristics
Color blue Score no score
Shape ROUND Size 8mm
Flavor Imprint Code H;T10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-869-01 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (31722-869-01)
2 NDC:31722-869-02 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (31722-869-02)
3 NDC:31722-869-03 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (31722-869-03)
4 NDC:31722-869-04 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (31722-869-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205646 07/16/2021
TOLVAPTAN tolvaptan tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-868
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOLVAPTAN (TOLVAPTAN) TOLVAPTAN 15 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
METHYL ALCOHOL
METHYLENE CHLORIDE
MICROCRYSTALLINE CELLULOSE 102
POVIDONE K30
LACTOSE MONOHYDRATE
Product Characteristics
Color white (off white) Score no score
Shape TRIANGLE Size 6mm
Flavor Imprint Code H;T9
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-868-01 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (31722-868-01)
2 NDC:31722-868-02 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (31722-868-02)
3 NDC:31722-868-03 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (31722-868-03)
4 NDC:31722-868-04 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (31722-868-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205646 09/06/2022
Labeler — Camber Pharmaceuticals, Inc. (826774775)
Establishment
Name Address ID/FEI Operations
Annora Pharma Private Limited 650980746 analysis (31722-868), analysis (31722-869), manufacture (31722-868), manufacture (31722-869)

Revised: 09/2022 Camber Pharmaceuticals, Inc.

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