NDC 0378-4714

Risedronate Sodium

Risedronate Sodium

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

• Product ID: 0378-4714_062b9bc9-0a74-42b3-9696-fa3012c9d6ac
• NDC: 0378-4714
• 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: 2015-11-30
• Marketing End Date: 2019-06-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA200477
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: RISEDRONATE SODIUM
• Active Ingredient Strength: 35 mg/1
• Pharm Classes: Bisphosphonate [EPC],Diphosphonates [CS]
• NDC Exclude Flag: N

Packaging

NDC 0378-4714-99

4 TABLET, FILM COATED in 1 BLISTER PACK (0378-4714-99)

• Marketing Start Date: 2015-11-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-4714-99 [00378471499]

Risedronate Sodium TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA200477
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-11-30
• Marketing End Date: 2019-06-30

NDC 0378-4714-96 [00378471496]

Risedronate Sodium TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA200477
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-02-04
• Marketing End Date: 2017-06-22

NDC 0378-4714-92 [00378471492]

Risedronate Sodium TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA200477
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-11-30
• Marketing End Date: 2017-06-22

Drug Details

Active Ingredients

Ingredient	Strength
RISEDRONATE SODIUM	35 mg/1

OpenFDA Data

• SPL SET ID: a80cd9bf-c308-4fad-b74a-23a8d5fdaaeb
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • OFG5EXG60L
• RxNorm Concept Unique ID - RxCUI:
  • 905024
  • 905032
  • 905092
  • 905028
  • 905041

Pharmacological Class

• 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