NDC 63304-440

RISEDRONATE SODIUM

Risedronate Sodium

RISEDRONATE SODIUM is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industires Inc.. The primary component is Risedronate Sodium.

Product ID63304-440_d97c9e6a-01e9-46ae-9088-0ca86b4eb842
NDC63304-440
Product TypeHuman Prescription Drug
Proprietary NameRISEDRONATE SODIUM
Generic NameRisedronate Sodium
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2019-07-10
Marketing CategoryANDA / ANDA
Application NumberANDA203925
Labeler NameSun Pharmaceutical Industires Inc.
Substance NameRISEDRONATE SODIUM
Active Ingredient Strength35 mg/1
Pharm ClassesBisphosphonate [EPC],Diphosphonates [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 63304-440-09

1 DOSE PACK in 1 CARTON (63304-440-09) > 4 TABLET, DELAYED RELEASE in 1 DOSE PACK (63304-440-11)
Marketing Start Date2019-07-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63304-440-11 [63304044011]

RISEDRONATE SODIUM TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203925
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-10

NDC 63304-440-09 [63304044009]

RISEDRONATE SODIUM TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203925
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-10

Drug Details

Active Ingredients

IngredientStrength
RISEDRONATE SODIUM35 mg/1

Pharmacological Class

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

NDC Crossover Matching brand name "RISEDRONATE SODIUM" or generic name "Risedronate Sodium"

NDCBrand NameGeneric Name
0093-3098Risedronate SodiumRisedronate Sodium
0093-3099Risedronate SodiumRisedronate Sodium
0093-3100Risedronate SodiumRisedronate Sodium
0093-7771Risedronate SodiumRisedronate Sodium
0378-4044Risedronate Sodiumrisedronate sodium
0378-4114Risedronate Sodiumrisedronate sodium
0378-4150Risedronate Sodiumrisedronate sodium
0378-4714Risedronate Sodiumrisedronate sodium
0591-2067risedronate sodiumrisedronate sodium
0591-2109risedronate sodiumrisedronate sodium
0591-2075risedronate sodiumrisedronate sodium
0591-2044risedronate sodiumrisedronate sodium
0591-2102risedronate sodiumrisedronate sodium
0591-3876Risedronate SodiumRisedronate Sodium
33342-107Risedronate SodiumRisedronate Sodium
33342-109Risedronate SodiumRisedronate Sodium
33342-108Risedronate SodiumRisedronate Sodium
47335-666risedronate sodiumrisedronate sodium
47335-667risedronate sodiumrisedronate sodium
47335-928risedronate sodiumrisedronate sodium
47335-727risedronate sodiumrisedronate sodium
47335-668risedronate sodiumrisedronate sodium
59762-0405Risedronate SodiumRisedronate Sodium
59762-0406Risedronate SodiumRisedronate Sodium
59762-0407Risedronate SodiumRisedronate Sodium
60505-3165Risedronate SodiumRisedronate Sodium
60723-041Risedronate SodiumRisedronate Sodium
60505-3096Risedronate SodiumRisedronate Sodium
60505-3097Risedronate SodiumRisedronate Sodium
65862-517Risedronate SodiumRisedronate Sodium
65862-518Risedronate SodiumRisedronate Sodium
65862-519Risedronate SodiumRisedronate Sodium
65862-870Risedronate SodiumRisedronate Sodium
68382-075Risedronate SodiumRisedronate Sodium
70771-1436Risedronate SodiumRisedronate Sodium
63304-440RISEDRONATE SODIUMRISEDRONATE SODIUM
0149-0470ACTONELRISEDRONATE SODIUM
0149-0471ACTONELRISEDRONATE SODIUM
0149-0472ACTONELRISEDRONATE SODIUM
0149-0478ACTONELRISEDRONATE SODIUM
0430-0470ActonelRisedronate Sodium
0430-0471ActonelRisedronate Sodium
0430-0472ActonelRisedronate Sodium
0430-0478ActonelRisedronate Sodium

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.