Risedronate Sodium

Product NDC
71205-714
11-digit product format
712050714
Labeler code
71205
Product ID
71205-714_81702f21-3117-49ce-8e9b-2aa2648ba7c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risedronate Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090877
Marketing category
ANDA
Marketing start
2015-11-30
Substance
RISEDRONATE SODIUM
Active strength
35 mg/1
Pharmacologic classes
Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Risedronate Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RISEDRONATE SODIUM35 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOFG5EXG60L
Rxcui905024

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
71205-714-04Risedronate Sodium4 in 1 BLISTER PACKTABLET, FILM COATED41
71205-714-04Risedronate Sodium1 in 1 CARTONTABLET, FILM COATED11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-714RISEDRONATE SODIUM TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, Legacy NDC, 2 package rows20221112_81702f21-3117-49ce-8e9b-2aa2648ba7c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905024risedronate sodium 35 MG Oral TabletPSN81702f21-3117-49ce-8e9b-2aa2648ba7c31
905024risedronate sodium 35 MG Oral TabletSCD81702f21-3117-49ce-8e9b-2aa2648ba7c31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-714-04712050714041 BLISTER PACK in 1 CARTON (71205-714-04) / 4 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2022-11-100000-00-00NoNoCurrent