NDC 69543-131

Alendronate

Alendronate Sodium

Alendronate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Virtus Pharmaceuticals. The primary component is Alendronate Sodium.

• Product ID: 69543-131_3fb471fa-c9db-4ed3-ac54-75b335828350
• NDC: 69543-131
• Product Type: Human Prescription Drug
• Proprietary Name: Alendronate
• Generic Name: Alendronate Sodium
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2015-10-02
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090258
• Labeler Name: Virtus Pharmaceuticals
• Substance Name: ALENDRONATE SODIUM
• Active Ingredient Strength: 70 mg/1
• Pharm Classes: Bisphosphonate [EPC],Diphosphonates [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 69543-131-04

1 BLISTER PACK in 1 CARTON (69543-131-04) > 4 TABLET in 1 BLISTER PACK

• Marketing Start Date: 2015-10-02
• Marketing End Date: 2024-03-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69543-131-20 [69543013120]

Alendronate TABLET

• Marketing Category: ANDA
• Application Number: ANDA090258
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-02-23

NDC 69543-131-12 [69543013112]

Alendronate TABLET

• Marketing Category: ANDA
• Application Number: ANDA090258
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-02-23

NDC 69543-131-04 [69543013104]

Alendronate TABLET

• Marketing Category: ANDA
• Application Number: ANDA090258
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-10-02

Drug Details

Active Ingredients

Ingredient	Strength
ALENDRONATE SODIUM	70 mg/1

OpenFDA Data

• SPL SET ID: 5c49d7fc-c76a-40c9-8c43-68b731230f0e
• Manufacturer:
  • Virtus Pharmaceuticals
• UNII:
  • 2UY4M2U3RA
• RxNorm Concept Unique ID - RxCUI:
  • 904431
  • 904396
• UPC Code:
  • 0369543131207

Pharmacological Class

• Bisphosphonate [EPC]
• Diphosphonates [CS]

Medicade Reported Pricing

69543013120 ALENDRONATE SODIUM 70 MG TAB

Pricing Unit: EA | Drug Type:

69543013112 ALENDRONATE SODIUM 70 MG TAB

Pricing Unit: EA | Drug Type:

69543013104 ALENDRONATE SODIUM 70 MG TAB

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Alendronate" or generic name "Alendronate Sodium"

NDC	Brand Name	Generic Name
10135-696	Alendronate	Alendronate Sodium
10135-697	Alendronate	Alendronate Sodium
10135-718	Alendronate	Alendronate sodium tablet
10135-719	Alendronate	Alendronate sodium tablet
68071-4017	Alendronate	Alendronate
68071-4072	Alendronate	Alendronate
69543-131	Alendronate	Alendronate
69543-130	Alendronate	Alendronate
50090-2587	Alendronate	Alendronate
50090-3593	Alendronate	Alendronate
60723-205	Alendronate	Alendronate
60723-207	Alendronate	Alendronate
63629-7329	Alendronate	Alendronate
0054-0282	Alendronate Sodium	Alendronate Sodium
0115-1676	Alendronate Sodium	Alendronate Sodium
0115-1678	Alendronate Sodium	Alendronate Sodium
0115-1679	Alendronate Sodium	Alendronate Sodium
0115-1680	Alendronate Sodium	Alendronate Sodium
0115-1681	Alendronate Sodium	Alendronate Sodium
0378-3566	Alendronate Sodium	alendronate sodium
16252-599	alendronate sodium	alendronate sodium
16252-601	alendronate sodium	alendronate sodium
16714-631	Alendronate Sodium	Alendronate Sodium
16714-632	Alendronate Sodium	Alendronate Sodium
16714-633	Alendronate Sodium	Alendronate Sodium
0178-0101	Binosto	alendronate sodium
17139-400	Binosto	alendronate sodium
0006-0031	FOSAMAX	alendronate sodium