NDC 0115-1680

Alendronate Sodium

Alendronate Sodium

Alendronate Sodium is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Of New York Llc. The primary component is Alendronate Sodium.

• Product ID: 0115-1680_2dbd21c3-1d2b-41a8-a355-e9c265b4c131
• NDC: 0115-1680
• Product Type: Human Prescription Drug
• Proprietary Name: Alendronate Sodium
• Generic Name: Alendronate Sodium
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2008-02-06
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075710
• Labeler Name: Amneal Pharmaceuticals of New York LLC
• Substance Name: ALENDRONATE SODIUM
• Active Ingredient Strength: 40 mg/1
• Pharm Classes: Bisphosphonate [EPC], Diphosphonates [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0115-1680-08

30 TABLET in 1 BOTTLE (0115-1680-08)

• Marketing Start Date: 2008-02-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0115-1680-08 [00115168008]

Alendronate Sodium TABLET

• Marketing Category: ANDA
• Application Number: ANDA075710
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-02-06

Drug Details

Active Ingredients

Ingredient	Strength
ALENDRONATE SODIUM	40 mg/1

OpenFDA Data

• SPL SET ID: c23fb7fe-c6b9-4f77-bde7-992222b589d3
• Manufacturer:
  • Impax Generics
• UNII:
  • 2UY4M2U3RA
• RxNorm Concept Unique ID - RxCUI:
  • 904405
  • 904431
  • 904425
  • 904419
  • 904396
• UPC Code:
  • 0301151681347
  • 0301151676084
  • 0301151680081
  • 0301151678088
  • 0301151679344

Pharmacological Class

• Bisphosphonate [EPC]
• Diphosphonates [CS]
• Bisphosphonate [EPC]
• Diphosphonates [CS]

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

NDC	Brand Name	Generic Name
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
21695-901	Alendronate Sodium	alendronate sodium
21695-902	Alendronate Sodium	alendronate sodium
33261-554	Alendronate Sodium	Alendronate Sodium
33261-820	Alendronate Sodium	Alendronate Sodium
68071-3340	ALENDRONATE SODIUM	ALENDRONATE SODIUM
68071-3171	ALENDRONATE SODIUM	ALENDRONATE SODIUM
68071-4120	alendronate sodium	alendronate sodium
68258-3014	Alendronate Sodium	Alendronate Sodium
68788-7130	ALENDRONATE SODIUM	ALENDRONATE SODIUM
68788-7393	Alendronate Sodium	Alendronate Sodium
68788-9463	Alendronate Sodium	Alendronate Sodium
69097-223	ALENDRONATE SODIUM	ALENDRONATE SODIUM
69097-224	ALENDRONATE SODIUM	ALENDRONATE SODIUM
70518-0033	ALENDRONATE SODIUM	ALENDRONATE SODIUM
70518-0269	alendronate sodium	alendronate sodium
71205-048	Alendronate Sodium	Alendronate Sodium
33261-993	Alendronate Sodium	Alendronate Sodium
50090-1802	Alendronate Sodium	Alendronate Sodium
50090-1091	alendronate sodium	alendronate sodium
50090-2322	Alendronate Sodium	Alendronate Sodium
50090-3126	Alendronate Sodium	Alendronate Sodium
50090-4076	ALENDRONATE SODIUM	ALENDRONATE SODIUM
51224-301	Alendronate Sodium	Alendronate Sodium
53217-321	alendronate sodium	alendronate sodium
55695-012	alendronate sodium	alendronate sodium
60429-055	Alendronate Sodium	Alendronate Sodium
60429-056	Alendronate Sodium	Alendronate Sodium
61919-689	ALENDRONATE SODIUM	ALENDRONATE SODIUM
61919-729	Alendronate Sodium	Alendronate Sodium
63187-175	Alendronate Sodium	Alendronate Sodium
63187-580	alendronate sodium	alendronate sodium
64980-340	Alendronate Sodium	Alendronate Sodium
64980-341	Alendronate Sodium	Alendronate Sodium
64980-342	Alendronate Sodium	Alendronate Sodium
65862-327	Alendronate Sodium	Alendronate Sodium
66116-428	Alendronate Sodium	Alendronate Sodium
65862-329	Alendronate Sodium	Alendronate Sodium
65862-328	Alendronate Sodium	Alendronate Sodium