Risedronate Sodium

Product NDC
60723-041
11-digit product format
607230041
Labeler code
60723
Product ID
60723-041_460cdef1-681b-7ae4-e063-6294a90a1d55
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risedronate Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd
Application
ANDA207516
Marketing category
ANDA
Marketing start
2019-04-01
Substance
RISEDRONATE SODIUM HEMI-PENTAHYDRATE
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 SODIUM HEMI-PENTAHYDRATE35 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHU2YAQ274O
Rxcui905024, 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
60723-041-01Risedronate Sodium4 in 1 BLISTER PACKTABLET, FILM COATED415
60723-041-04Risedronate Sodium1 in 1 CARTONTABLET, FILM COATED115
60723-041-12Risedronate Sodium3 in 1 CARTONTABLET, FILM COATED315

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60723-041RISEDRONATE SODIUM TABLET, FILM COATED [HANGZHOU MINSHENG BINJIANG PHARMACEUTICAL CO., LTD]14Current NDC, Legacy NDC, 3 package rows20241123_d60a56cb-ef49-4447-9043-7b6879a20d75.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905100{12 (risedronate sodium 35 MG Oral Tablet) } PackGPCKd60a56cb-ef49-4447-9043-7b6879a20d7515
905092{4 (risedronate sodium 35 MG Oral Tablet) } PackGPCKd60a56cb-ef49-4447-9043-7b6879a20d7515
905100risedronate sodium 35 MG (12) Oral Tablet PackPSNd60a56cb-ef49-4447-9043-7b6879a20d7515
905092risedronate sodium 35 MG (4) Oral Tablet PackPSNd60a56cb-ef49-4447-9043-7b6879a20d7515
905024risedronate sodium 35 MG Oral TabletPSNd60a56cb-ef49-4447-9043-7b6879a20d7515
905024risedronate sodium 35 MG Oral TabletSCDd60a56cb-ef49-4447-9043-7b6879a20d7515
905100risedronate sodium 35 MG Oral Tablet, 12 Week PackSYd60a56cb-ef49-4447-9043-7b6879a20d7515
905092risedronate sodium 35 MG Oral Tablet, 4 Week PackSYd60a56cb-ef49-4447-9043-7b6879a20d7515

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60723-041-01607230041014 in 1 BLISTER PACKHistorical
60723-041-04607230041041 BLISTER PACK in 1 CARTON (60723-041-04) / 4 TABLET, FILM COATED in 1 BLISTER PACK (60723-041-01) 1 blister pack2019-04-010000-00-00NoNoCurrent
60723-041-12607230041123 BLISTER PACK in 1 CARTON (60723-041-12) / 4 TABLET, FILM COATED in 1 BLISTER PACK (60723-041-01) 3 blister pack2019-04-010000-00-00NoNoCurrent