Tadalafil: Package Insert and Label Information (Page 8 of 8)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 2.5 mg (30 Tablets Bottle)

NDC 65862-850-30
Rx only
Tadalafil Tablets USP
2.5 mg
for once daily use
Tablets should not be split.
Entire dose should be taken.AUROBINDO 30 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 2.5 mg Blister Carton (2×15 Unit-dose)

NDC 65862-850-32
Rx only
Tadalafil Tablets USP
2.5 mg
for once daily use
Tablets should not be split.
Entire dose should be taken.
AUROBINDO 30 tablets (2 blisters of 15 tablets)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 5 mg (30 Tablets Bottle)

NDC 65862-851-30
Rx only
Tadalafil Tablets USP
5 mg
Tablets should not be split.
Entire dose should be taken.
AUROBINDO 30 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 5 mg Blister Carton (2×15 Unit-dose)

NDC 65862-851-32
Rx only
Tadalafil Tablets USP
5 mg
for once daily use
Tablets should not be split.
Entire dose should be taken.
AUROBINDO 30 tablets (2 blisters of 15 tablets)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 5 mg Blister Carton (2×15 Unit-dose)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg (30 Tablets Bottle)

NDC 65862-852-30
Rx only
Tadalafil Tablets USP
10 mg
Tablets should not be split.
Entire dose should be taken.
AUROBINDO 30 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 20 mg (30 Tablets Bottle)

NDC 65862-853-30
Rx only
Tadalafil Tablets USP
20 mg
Tablets should not be split.
Entire dose should be taken.
AUROBINDO 30 Tablets

TADALAFIL tadalafil tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-850 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TADALAFIL (TADALAFIL) TADALAFIL 2.5 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE COPOVIDONE K25-31 CROSCARMELLOSE SODIUM HYPROMELLOSE 2910 (6 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE 102 POLYOXYL 40 HYDROGENATED CASTOR OIL TALC TITANIUM DIOXIDE TRIACETIN FERRIC OXIDE YELLOW FERRIC OXIDE RED

Product Characteristics Color ORANGE (Light Orange-Yellow) Score no score Shape OVAL Size 6mm Flavor Imprint Code 1;L Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65862-850-30 30 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:65862-850-32 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK 2 15 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65862-850-32)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206285 03/26/2019

TADALAFIL tadalafil tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-851 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TADALAFIL (TADALAFIL) TADALAFIL 5 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE COPOVIDONE K25-31 CROSCARMELLOSE SODIUM HYPROMELLOSE 2910 (6 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE 102 POLYOXYL 40 HYDROGENATED CASTOR OIL TALC TITANIUM DIOXIDE TRIACETIN FERRIC OXIDE YELLOW

Product Characteristics Color YELLOW (Light Yellow) Score no score Shape OVAL Size 8mm Flavor Imprint Code 56;L Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65862-851-30 30 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:65862-851-32 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK 2 15 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65862-851-32)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206285 03/26/2019

TADALAFIL tadalafil tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-852 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TADALAFIL (TADALAFIL) TADALAFIL 10 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE COPOVIDONE K25-31 CROSCARMELLOSE SODIUM HYPROMELLOSE 2910 (6 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE 102 POLYOXYL 40 HYDROGENATED CASTOR OIL TALC TITANIUM DIOXIDE TRIACETIN FERRIC OXIDE YELLOW

Product Characteristics Color YELLOW (Light Yellow) Score no score Shape OVAL Size 11mm Flavor Imprint Code 57;L Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65862-852-30 30 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:65862-852-05 500 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:65862-852-99 1000 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206285 03/26/2019

TADALAFIL tadalafil tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-853 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TADALAFIL (TADALAFIL) TADALAFIL 20 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE COPOVIDONE K25-31 CROSCARMELLOSE SODIUM HYPROMELLOSE 2910 (6 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE 102 POLYOXYL 40 HYDROGENATED CASTOR OIL TALC TITANIUM DIOXIDE TRIACETIN FERRIC OXIDE YELLOW

Product Characteristics Color YELLOW Score no score Shape OVAL Size 13mm Flavor Imprint Code 58;L Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65862-853-30 30 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:65862-853-05 500 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:65862-853-99 1000 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206285 03/26/2019

Labeler — Aurobindo Pharma Limited (650082092)

Establishment
Name	Address	ID/FEI	Operations
Aurobindo Pharma Limited		650381903	ANALYSIS (65862-850), ANALYSIS (65862-851), ANALYSIS (65862-852), ANALYSIS (65862-853), MANUFACTURE (65862-850), MANUFACTURE (65862-851), MANUFACTURE (65862-852), MANUFACTURE (65862-853)

Revised: 09/2021 Aurobindo Pharma Limited