FDA.reportPublic FDA data

Risedronate Sodium

Product NDC
59762-0407
11-digit product format
597620407
Labeler code
59762
Product ID
59762-0407_b7e3ea01-4634-467a-b087-3d52ef7af465
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
risedronate sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Mylan Pharmaceuticals, Inc.
Application
NDA022560
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-03-02
Substance
RISEDRONATE SODIUM HEMIPENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE
Active strength
30.1; 4.9 mg/1; mg/1
Pharmacologic classes
Bisphosphonate [EPC], Bisphosphonate [EPC], Diphosphonates [CS], Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Risedronate Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RISEDRONATE SODIUM HEMIPENTAHYDRATE30.1 mg/1
RISEDRONATE SODIUM MONOHYDRATE4.9 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHU2YAQ274O, F67L43UT5C
Rxcui1020064, 1020065

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc99ed49-98e9-42a6-aef0-a6dc585a6a09Product name420191002
a51ae56f-109a-47a0-9ce1-2b825be8c01bProduct name520190614

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59762-0407-4Risedronate Sodium4 in 1 DOSE PACKTABLET, DELAYED RELEASE47

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-0407-4EA - Each59762-0407a27ccdd9-320a-4c88-9acc-cfee2287f4dd12018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-0407RISEDRONATE SODIUM TABLET, DELAYED RELEASE [GREENSTONE LLC]5Current NDC, Legacy NDC, 1 package rows20240119_c89430be-15f1-4b8b-ab7e-738de716ee7d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020065{4 (risedronate sodium 35 MG Delayed Release Oral Tablet) } PackGPCKc89430be-15f1-4b8b-ab7e-738de716ee7d7
1020064risedronate sodium 35 MG Delayed Release Oral TabletPSNc89430be-15f1-4b8b-ab7e-738de716ee7d7
1020065risedronate sodium 35 MG Delayed Release Oral Tablet 4 Count PackPSNc89430be-15f1-4b8b-ab7e-738de716ee7d7
1020064risedronate sodium 35 MG Delayed Release Oral TabletSCDc89430be-15f1-4b8b-ab7e-738de716ee7d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59762-0407-4597620407044 TABLET, DELAYED RELEASE in 1 DOSE PACK (59762-0407-4) 2018-03-020000-00-00NoNoCurrent