NDC 0004-0186

Boniva

Ibandronate Sodium

Boniva is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Genentech, Inc.. The primary component is Ibandronate Sodium.

• Product ID: 0004-0186_4995d52a-c085-4716-abfd-12714c5c2cec
• NDC: 0004-0186
• Product Type: Human Prescription Drug
• Proprietary Name: Boniva
• Generic Name: Ibandronate Sodium
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2005-03-24
• Marketing Category: NDA / NDA
• Application Number: NDA021455
• Labeler Name: Genentech, Inc.
• Substance Name: IBANDRONATE SODIUM
• Active Ingredient Strength: 150 mg/1
• Pharm Classes: Bisphosphonate [EPC],Diphosphonates [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0004-0186-83

1 BLISTER PACK in 1 BOX (0004-0186-83) > 3 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2014-12-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0004-0186-82 [00004018682]

Boniva TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021455
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2005-03-24
• Marketing End Date: 2019-01-31

NDC 0004-0186-98 [00004018698]

Boniva TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021455
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-02-03
• Marketing End Date: 2015-01-13

NDC 0004-0186-83 [00004018683]

Boniva TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021455
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-12-17

Drug Details

Active Ingredients

Ingredient	Strength
IBANDRONATE SODIUM	150 mg/1

OpenFDA Data

• SPL SET ID: 841bf769-0148-42a8-a4d0-ff062b4734e8
• Manufacturer:
  • Genentech, Inc.
• UNII:
  • J12U072QL0
• RxNorm Concept Unique ID - RxCUI:
  • 904934
  • 904932

Pharmacological Class

• Bisphosphonate [EPC]
• Diphosphonates [CS]

NDC Crossover Matching brand name "Boniva" or generic name "Ibandronate Sodium"

NDC	Brand Name	Generic Name
0004-0186	Boniva	ibandronate sodium
0004-0191	Boniva	ibandronate sodium
23155-162	Ibandronate sodium	Ibandronate sodium
25021-827	ibandronate sodium	ibandronate sodium
33342-150	IBANDRONATE SODIUM	IBANDRONATE SODIUM
47781-103	IBANDRONATE SODIUM	IBANDRONATE SODIUM
51224-008	IBANDRONATE SODIUM	Ibandronate Sodium
55111-575	Ibandronate sodium	Ibandronate sodium
55150-191	Ibandronate Sodium	Ibandronate Sodium
60429-643	IBANDRONATE SODIUM	IBANDRONATE SODIUM
60505-2795	IBANDRONATE SODIUM	IBANDRONATE SODIUM
60505-6097	Ibandronate Sodium	ibandronate sodium
62756-218	IBANDRONATE SODIUM	IBANDRONATE SODIUM
65862-237	Ibandronate Sodium	Ibandronate Sodium
67457-524	ibandronate sodium	ibandronate sodium