FDA.reportPublic FDA data

risedronate sodium

Product NDC
47335-727
11-digit product format
473350727
Labeler code
47335
Product ID
47335-727_a9910c38-e099-4f8a-a7e9-a88623be2032
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
risedronate sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA090886
Marketing category
ANDA
Marketing start
2014-06-11
Substance
RISEDRONATE SODIUM HEMI-PENTAHYDRATE
Active strength
75 mg/1
Pharmacologic classes
Bisphosphonate [EPC], 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 HEMI-PENTAHYDRATE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHU2YAQ274O
Rxcui905024, 905028, 905032, 905041, 905083, 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
47335-727-98risedronate sodium2 in 1 BLISTER PACKTABLET, FILM COATED217
47335-727-98risedronate sodium1 in 1 CARTONTABLET, FILM COATED117

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-727RISEDRONATE SODIUM TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]15Current NDC, Legacy NDC, 2 package rows20240704_e0b5f0ed-ff40-4f0d-bb86-81a7ace9f339.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905100{12 (risedronate sodium 35 MG Oral Tablet) } PackGPCKe0b5f0ed-ff40-4f0d-bb86-81a7ace9f33917
905092{4 (risedronate sodium 35 MG Oral Tablet) } PackGPCKe0b5f0ed-ff40-4f0d-bb86-81a7ace9f33917
905028risedronate sodium 150 MG Oral TabletPSNe0b5f0ed-ff40-4f0d-bb86-81a7ace9f33917
905032risedronate sodium 30 MG Oral TabletPSNe0b5f0ed-ff40-4f0d-bb86-81a7ace9f33917
905100risedronate sodium 35 MG (12) Oral Tablet PackPSNe0b5f0ed-ff40-4f0d-bb86-81a7ace9f33917
905092risedronate sodium 35 MG (4) Oral Tablet PackPSNe0b5f0ed-ff40-4f0d-bb86-81a7ace9f33917
905024risedronate sodium 35 MG Oral TabletPSNe0b5f0ed-ff40-4f0d-bb86-81a7ace9f33917
905041risedronate sodium 5 MG Oral TabletPSNe0b5f0ed-ff40-4f0d-bb86-81a7ace9f33917
905083risedronate sodium 75 MG Oral TabletPSNe0b5f0ed-ff40-4f0d-bb86-81a7ace9f33917
905028risedronate sodium 150 MG Oral TabletSCDe0b5f0ed-ff40-4f0d-bb86-81a7ace9f33917
905032risedronate sodium 30 MG Oral TabletSCDe0b5f0ed-ff40-4f0d-bb86-81a7ace9f33917
905024risedronate sodium 35 MG Oral TabletSCDe0b5f0ed-ff40-4f0d-bb86-81a7ace9f33917
905041risedronate sodium 5 MG Oral TabletSCDe0b5f0ed-ff40-4f0d-bb86-81a7ace9f33917
905083risedronate sodium 75 MG Oral TabletSCDe0b5f0ed-ff40-4f0d-bb86-81a7ace9f33917
905100risedronate sodium 35 MG Oral Tablet, 12 Week PackSYe0b5f0ed-ff40-4f0d-bb86-81a7ace9f33917
905092risedronate sodium 35 MG Oral Tablet, 4 Week PackSYe0b5f0ed-ff40-4f0d-bb86-81a7ace9f33917

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47335-727-98473350727981 BLISTER PACK in 1 CARTON (47335-727-98) / 2 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2014-06-110000-00-00NoNoCurrent