NDC 16714-870

Risedronate Sodium

Risedronate Sodium

Risedronate Sodium is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Northstar Rxllc. The primary component is Risedronate Sodium.

Product ID16714-870_7b9bda88-4331-4285-b897-1945948ea8b6
NDC16714-870
Product TypeHuman Prescription Drug
Proprietary NameRisedronate Sodium
Generic NameRisedronate Sodium
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2019-08-14
Marketing CategoryANDA / ANDA
Application NumberANDA203925
Labeler NameNorthStar RxLLC
Substance NameRISEDRONATE SODIUM
Active Ingredient Strength35 mg/1
Pharm ClassesBisphosphonate [EPC],Diphosphonates [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 16714-870-02

1 DOSE PACK in 1 CARTON (16714-870-02) > 4 TABLET, DELAYED RELEASE in 1 DOSE PACK (16714-870-01)
Marketing Start Date2019-08-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16714-870-02 [16714087002]

Risedronate Sodium TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203925
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-14

NDC 16714-870-01 [16714087001]

Risedronate Sodium TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203925
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-14

Drug Details

Active Ingredients

IngredientStrength
RISEDRONATE SODIUM35 mg/1

OpenFDA Data

SPL SET ID:95fce48f-5ebc-4d49-a97c-1e4f2a71d507
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1020064
  • 1020065
  • 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.