NDC 0591-2075

risedronate sodium

Risedronate Sodium

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

• Product ID: 0591-2075_3eedc23c-7012-4057-b5b2-0bf4c2850b6f
• NDC: 0591-2075
• Product Type: Human Prescription Drug
• Proprietary Name: risedronate sodium
• Generic Name: Risedronate Sodium
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2014-06-27
• Marketing End Date: 2021-05-31
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA020835
• Labeler Name: Actavis Pharma, 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

Packaging

NDC 0591-2075-04

4 TABLET, FILM COATED in 1 DOSE PACK (0591-2075-04)

• Marketing Start Date: 2014-06-27
• Marketing End Date: 2021-05-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0591-2075-39 [00591207539]

risedronate sodium TABLET, FILM COATED

• Marketing Category: NDA AUTHORIZED GENERIC
• Application Number: NDA020835
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-06-27
• Marketing End Date: 2021-05-31

NDC 0591-2075-04 [00591207504]

risedronate sodium TABLET, FILM COATED

• Marketing Category: NDA AUTHORIZED GENERIC
• Application Number: NDA020835
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-06-27
• Marketing End Date: 2021-05-31

Drug Details

Active Ingredients

Ingredient	Strength
RISEDRONATE SODIUM HEMI-PENTAHYDRATE	30.1 mg/1

OpenFDA Data

• SPL SET ID: 1d33f2ef-ec29-47b1-a1ce-8b1583c65ab4
• Manufacturer:
  • Actavis Pharma, Inc.
• UNII:
  • HU2YAQ274O
  • F67L43UT5C
• RxNorm Concept Unique ID - RxCUI:
  • 905024
  • 905032
  • 905100
  • 905028
  • 905083
  • 905092
  • 905041
• UPC Code:
  • 0305912102300
  • 0305912109309
  • 0305912044549

Pharmacological Class

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

NDC Crossover Matching brand name "risedronate sodium" or generic name "Risedronate Sodium"

NDC	Brand Name	Generic Name
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
0591-2067	risedronate sodium	risedronate sodium
0591-2109	risedronate sodium	risedronate sodium
0591-2075	risedronate sodium	risedronate sodium
0591-2044	risedronate sodium	risedronate sodium
0591-2102	risedronate sodium	risedronate sodium
0591-3876	Risedronate Sodium	Risedronate Sodium
33342-107	Risedronate Sodium	Risedronate Sodium
33342-109	Risedronate Sodium	Risedronate Sodium
33342-108	Risedronate Sodium	Risedronate Sodium
47335-666	risedronate sodium	risedronate sodium
47335-667	risedronate sodium	risedronate sodium
47335-928	risedronate sodium	risedronate sodium
47335-727	risedronate sodium	risedronate sodium
47335-668	risedronate sodium	risedronate sodium
59762-0405	Risedronate Sodium	Risedronate Sodium
59762-0406	Risedronate Sodium	Risedronate Sodium
59762-0407	Risedronate Sodium	Risedronate Sodium
60505-3165	Risedronate Sodium	Risedronate Sodium
60723-041	Risedronate Sodium	Risedronate Sodium
60505-3096	Risedronate Sodium	Risedronate Sodium
60505-3097	Risedronate Sodium	Risedronate Sodium
65862-517	Risedronate Sodium	Risedronate Sodium
65862-518	Risedronate Sodium	Risedronate Sodium
65862-519	Risedronate Sodium	Risedronate Sodium
65862-870	Risedronate Sodium	Risedronate Sodium
68382-075	Risedronate Sodium	Risedronate Sodium
70771-1436	Risedronate Sodium	Risedronate Sodium
63304-440	RISEDRONATE SODIUM	RISEDRONATE SODIUM
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