Reclast

Product NDC
66758-155
11-digit product format
667580155
Labeler code
66758
Product ID
66758-155_12a00376-75c0-41e4-b0a5-d8adb81a3cc4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zoledronic acid
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sandoz Inc
Application
NDA021817
Marketing category
NDA
Marketing start
2007-04-01
Substance
ZOLEDRONIC ACID
Active strength
5 mg/100mL
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
Reclast
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZOLEDRONIC ACID5 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6XC1PAD3KF
Rxcui705824, 705875

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
963c7720-927d-e443-b968-0d27f7055a69Product name820240606
95fe9bf2-51a5-1324-90da-8451ccf59619Product name920190228
76bb2633-9686-4c41-9e21-c755e223f2e0Product name120160408
94acf8b5-886e-4cdd-b38e-791d5af82ba0Product name120150325

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66758-155-46Reclast100 mL in 1 BOTTLEINJECTION, SOLUTION1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66758-155RECLAST (ZOLEDRONIC ACID) INJECTION, SOLUTION [SANDOZ INC]1Current NDC, 1 package rows20241228_5a9b3737-9ce6-4a89-b76e-6aab79eba9cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705875Reclast 5 MG in 100 ML InjectionPSN5a9b3737-9ce6-4a89-b76e-6aab79eba9cf3
705824zoledronic acid 5 MG in 100 ML InjectionPSN5a9b3737-9ce6-4a89-b76e-6aab79eba9cf3
705875100 ML zoledronic acid 0.05 MG/ML Injection [Reclast]SBD5a9b3737-9ce6-4a89-b76e-6aab79eba9cf3
705824100 ML zoledronic acid 0.05 MG/ML InjectionSCD5a9b3737-9ce6-4a89-b76e-6aab79eba9cf3
705875Reclast 0.05 MG/ML per 100 ML InjectionSY5a9b3737-9ce6-4a89-b76e-6aab79eba9cf3
705875Reclast 5 MG per 100 ML InjectionSY5a9b3737-9ce6-4a89-b76e-6aab79eba9cf3
705824zoledronic acid 5 MG per 100 ML InjectionSY5a9b3737-9ce6-4a89-b76e-6aab79eba9cf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66758-155-4666758015546100 mL in 1 BOTTLE (66758-155-46) 100 ml2024-12-18NoNoCurrent