NDC 0378-3288

Etidronate Disodium

Etidronate Disodium

Etidronate Disodium is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Etidronate Disodium.

• Product ID: 0378-3288_74efb146-06c1-4458-82eb-ff948f20d6e1
• NDC: 0378-3288
• Product Type: Human Prescription Drug
• Proprietary Name: Etidronate Disodium
• Generic Name: Etidronate Disodium
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2008-01-02
• Marketing End Date: 2019-12-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075800
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: ETIDRONATE DISODIUM
• Active Ingredient Strength: 400 mg/1
• Pharm Classes: Bisphosphonate [EPC],Diphosphonates [CS]
• NDC Exclude Flag: N

Packaging

NDC 0378-3288-91

60 TABLET in 1 BOTTLE, PLASTIC (0378-3288-91)

• Marketing Start Date: 2008-01-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-3288-91 [00378328891]

Etidronate Disodium TABLET

• Marketing Category: ANDA
• Application Number: ANDA075800
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-01-02
• Marketing End Date: 2019-12-31

Drug Details

Active Ingredients

Ingredient	Strength
ETIDRONATE DISODIUM	400 mg/1

OpenFDA Data

• SPL SET ID: fa07734d-b381-4f33-a555-53b6614f4b08
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • M16PXG993G
• RxNorm Concept Unique ID - RxCUI:
  • 904535
  • 904547

Pharmacological Class

• Bisphosphonate [EPC]
• Diphosphonates [CS]

NDC Crossover Matching brand name "Etidronate Disodium" or generic name "Etidronate Disodium"

NDC	Brand Name	Generic Name
0378-3286	Etidronate Disodium	etidronate disodium
0378-3288	Etidronate Disodium	etidronate disodium
68151-1521	Etidronate Disodium	etidronate disodium