Aliskiren (Page 8 of 8)

Principal Display Panel — Package Label – 150 mg

NDC 66993-141-30

30 Tablets

Rx only

PRASCO

Aliskiren

Tablets

150 mg

150 mg label
(click image for full-size original)
150 mg Novartis label
(click image for full-size original)

Principal Display Panel — Package Label – 300 mg

NDC 66993-142-30

30 Tablets

Rx only

PRASCO

Aliskiren

Tablets

300 mg

300 mg label
(click image for full-size original)
300 mg Novartis label
(click image for full-size original)

ALISKIREN aliskiren hemifumarate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66993-141
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALISKIREN HEMIFUMARATE (ALISKIREN) ALISKIREN 150 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (15 MPA.S AT 5%)
HYPROMELLOSES
FERRIC OXIDE RED
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
Product Characteristics
Color pink (light-pink) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code NVR;IL
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66993-141-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA021985 03/04/2019
ALISKIREN aliskiren hemifumarate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66993-142
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALISKIREN HEMIFUMARATE (ALISKIREN) ALISKIREN 300 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (15 MPA.S AT 5%)
HYPROMELLOSES
FERRIC OXIDE RED
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
Product Characteristics
Color red (light-red) Score no score
Shape OVAL (Ovaloid) Size 18mm
Flavor Imprint Code NVR;IU
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66993-142-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA021985 03/04/2019
Labeler — Prasco Laboratories (065969375)

Revised: 05/2023 Prasco Laboratories

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