FDA.reportPublic FDA data

Risedronate Sodium

Product NDC
59762-0406
11-digit product format
597620406
Labeler code
59762
Product ID
59762-0406_6015697f-84b2-49c4-b59a-87956261df64
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risedronate Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals, Inc.
Application
NDA020835
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2008-04-22
Substance
RISEDRONATE SODIUM HEMIPENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE
Active strength
129; 21 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 HEMIPENTAHYDRATE129 mg/1
RISEDRONATE SODIUM MONOHYDRATE21 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHU2YAQ274O, F67L43UT5C
Rxcui905024, 905028, 905092, 905100

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
59762-0406-1Risedronate Sodium1 in 1 DOSE PACKTABLET, FILM COATED113
59762-0406-3Risedronate Sodium3 in 1 DOSE PACKTABLET, FILM COATED313

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-0406-1EA - Each59762-0406b6544c08-26dd-4caf-984a-95ada1435bb712018-11-06
59762-0406-3EA - Each59762-040664aaed10-cc28-4111-a073-40254604876e12019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-0406RISEDRONATE SODIUM TABLET, FILM COATED [GREENSTONE LLC]10Current NDC, Legacy NDC, 2 package rows20240119_f715718a-407d-4e2a-9834-74a8f1361d03.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905100{12 (risedronate sodium 35 MG Oral Tablet) } PackGPCKf715718a-407d-4e2a-9834-74a8f1361d0313
905092{4 (risedronate sodium 35 MG Oral Tablet) } PackGPCKf715718a-407d-4e2a-9834-74a8f1361d0313
905028risedronate sodium 150 MG Oral TabletPSNf715718a-407d-4e2a-9834-74a8f1361d0313
905100risedronate sodium 35 MG (12) Oral Tablet PackPSNf715718a-407d-4e2a-9834-74a8f1361d0313
905092risedronate sodium 35 MG (4) Oral Tablet PackPSNf715718a-407d-4e2a-9834-74a8f1361d0313
905024risedronate sodium 35 MG Oral TabletPSNf715718a-407d-4e2a-9834-74a8f1361d0313
905028risedronate sodium 150 MG Oral TabletSCDf715718a-407d-4e2a-9834-74a8f1361d0313
905024risedronate sodium 35 MG Oral TabletSCDf715718a-407d-4e2a-9834-74a8f1361d0313
905100risedronate sodium 35 MG Oral Tablet, 12 Week PackSYf715718a-407d-4e2a-9834-74a8f1361d0313
905092risedronate sodium 35 MG Oral Tablet, 4 Week PackSYf715718a-407d-4e2a-9834-74a8f1361d0313

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59762-0406-1597620406011 TABLET, FILM COATED in 1 DOSE PACK (59762-0406-1) 2008-04-220000-00-00NoNoCurrent
59762-0406-3597620406033 TABLET, FILM COATED in 1 DOSE PACK (59762-0406-3) 2008-04-220000-00-00NoNoCurrent