NDC Code(s) : 10135-696-44, 10135-696-12, 10135-697-44, 10135-697-12, 10135-697-20
Packager : Marlex Pharmaceuticals Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AlendronateAlendronate Sodium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10135-696
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALENDRONATE SODIUM(UNII: 2UY4M2U3RA)
(ALENDRONIC ACID - UNII:X1J18R4W8P) 		ALENDRONIC ACID35 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape OVAL (modified oval) Size 13 mm
Flavor Imprint Code AP207
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10135-696-441 in 1 CARTON 03/01/2020
14 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:10135-696-123 in 1 CARTON 03/01/2020
24 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090258 03/01/2020
AlendronateAlendronate Sodium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10135-697
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALENDRONATE SODIUM(UNII: 2UY4M2U3RA)
(ALENDRONIC ACID - UNII:X1J18R4W8P) 		ALENDRONIC ACID70 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 16 mm
Flavor Imprint Code AP205
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10135-697-441 in 1 CARTON 03/01/2020
14 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:10135-697-123 in 1 CARTON 03/01/2020
24 in 1 BLISTER PACK Type 0: Not a Combination Product
3NDC:10135-697-202 in 1 CARTON 03/01/2020
310 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090258 03/01/2020

LABELER - Marlex Pharmaceuticals Inc(782540215)

PRINCIPAL DISPLAY PANEL

- 35 mg Tablet Blis ter Pack Carton

4 Tablets

Rx only

NDC 10135-0696-44

Once Weekly

 

PRINCIPAL DISPLAY PANEL - 35 mg Tablet Blister Pack Carton 4 Tablets Rx only NDC 10135-0696-44 Once Weekly

PRINCIPAL DISPLAY PANEL

- 35 mg Tablet Blis ter Pack Carton

12 (3×4) Unit-of-Us e Tablets

Rx only

NDC 10135-0696-12

Once Weekly

PRINCIPAL DISPLAY PANEL - 35 mg Tablet Blister Pack Carton 12 (3×4) Unit-of-Us e Tablets Rx only NDC 10135-0696-12 Once Weekly

PRINCIPAL DISPLAY PANEL

- 70 mg Tablet Blis ter Pack Carton

4 Tablets

Rx only

NDC 10135-0697-44

Once Weekly

PRINCIPAL DISPLAY PANEL - 70 mg Tablet Blister Pack Carton 4 Tablets Rx only NDC 10135-0697-44 Once Weekly

PRINCIPAL DISPLAY PANEL

- 70 mg Tablet Blis ter Pack Carton

12 (3×4) Unit-of-Us e Tablets

Rx only

NDC 10135-0697-12      

Once Weekly

PRINCIPAL DISPLAY PANEL - 70 mg Tablet Blister Pack Carton 12 (3×4) Unit-of-Use Tablets Rx only NDC 10135-0697-12 Once Weekly

PRINCIPAL DISPLAY PANEL

- 70 mg Tablet Blis ter Pack Carton

20 (2×10) Unit-Dos e Tablets

Rx only

NDC 10135-0697-20

Once Weekly

PRINCIPAL DISPLAY PANEL - 70 mg Tablet Blister Pack Carton 20 (2×10) Unit-Dose Tablets Rx only NDC 10135-0697-20 Once Weekly