NDC 0430-0472

Actonel

Risedronate Sodium

Actonel is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Risedronate Sodium Hemi-pentahydrate; Risedronate Sodium Monohydrate.

• Product ID: 0430-0472_0a53e1f4-98c8-4ea5-be4a-d1a9709bdc60
• NDC: 0430-0472
• Product Type: Human Prescription Drug
• Proprietary Name: Actonel
• Generic Name: Risedronate Sodium
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2002-05-17
• Marketing Category: NDA / NDA
• Application Number: NDA020835
• Labeler Name: Allergan, Inc.
• Substance Name: RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE
• Active Ingredient Strength: 30 mg/1; mg/1
• Pharm Classes: Bisphosphonate [EPC],Diphosphonates [CS],Bisphosphonate [EPC],Diphosphonates [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0430-0472-03

4 TABLET, FILM COATED in 1 DOSE PACK (0430-0472-03)

• Marketing Start Date: 2002-05-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0430-0472-07 [00430047207]

Actonel TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020835
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2002-05-17

NDC 0430-0472-03 [00430047203]

Actonel TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020835
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2002-05-17

Drug Details

Active Ingredients

Ingredient	Strength
RISEDRONATE SODIUM HEMI-PENTAHYDRATE	30.1 mg/1

OpenFDA Data

• SPL SET ID: 24ed00e0-25e2-49a8-97fc-66c1b417dc0b
• Manufacturer:
  • Allergan, Inc.
• UNII:
  • HU2YAQ274O
  • F67L43UT5C
• RxNorm Concept Unique ID - RxCUI:
  • 905024
  • 905032
  • 905026
  • 905030
  • 905100
  • 905034
  • 905028
  • 905101
  • 905083
  • 905093
  • 905092
  • 905086
  • 905043
  • 905084
  • 905041
  • 905087

Pharmacological Class

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

NDC Crossover Matching brand name "Actonel" or generic name "Risedronate Sodium"

NDC	Brand Name	Generic Name
0149-0470	ACTONEL	RISEDRONATE SODIUM
0149-0471	ACTONEL	RISEDRONATE SODIUM
0149-0472	ACTONEL	RISEDRONATE SODIUM
0149-0478	ACTONEL	RISEDRONATE SODIUM
0430-0470	Actonel	Risedronate Sodium
0430-0471	Actonel	Risedronate Sodium
0430-0472	Actonel	Risedronate Sodium
0430-0478	Actonel	Risedronate Sodium
0093-3098	Risedronate Sodium	Risedronate Sodium
0093-3099	Risedronate Sodium	Risedronate Sodium
0093-3100	Risedronate Sodium	Risedronate Sodium
0093-7771	Risedronate Sodium	Risedronate Sodium
0378-4044	Risedronate Sodium	risedronate sodium
0378-4114	Risedronate Sodium	risedronate sodium
0378-4150	Risedronate Sodium	risedronate sodium
0378-4714	Risedronate Sodium	risedronate sodium