Prescription Drug Information: Dabigatran Etexilate (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dabigatran Etexilate Capsules 75 mg Container Label

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Dabigatran Etexilate Capsules 75 mg Container Carton

dabigatrancap75mgcontcarton
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Dabigatran Etexilate Capsules 150 mg Container Label

dabigatrancap150mgcontlabel
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Dabigatran Etexilate Capsules 150 mg Container Carton

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DABIGATRAN ETEXILATE dabigatran etexilate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-621
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DABIGATRAN ETEXILATE MESYLATE (DABIGATRAN) DABIGATRAN ETEXILATE 75 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE
HYPROMELLOSES
SUCROSE
STARCH, CORN
TALC
TARTARIC ACID
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
AMMONIA
Product Characteristics
Color white (yellowish white pellets) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code H;D10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-621-60 60 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207961 05/06/2020
DABIGATRAN ETEXILATE dabigatran etexilate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-622
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DABIGATRAN ETEXILATE MESYLATE (DABIGATRAN) DABIGATRAN ETEXILATE 150 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE
HYPROMELLOSES
SUCROSE
STARCH, CORN
TALC
TARTARIC ACID
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
AMMONIA
Product Characteristics
Color white (yellowish white pellets) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code H;D11
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-622-60 60 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207961 05/06/2020
Labeler — Camber Pharmaceuticals, Inc. (826774775)
Establishment
Name Address ID/FEI Operations
Hetero Labs Limited Unit III 676162024 manufacture (31722-621), manufacture (31722-622)

Revised: 05/2022 Camber Pharmaceuticals, Inc.

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