Pamidronate Disodium

Product NDC
67457-430
11-digit product format
674570430
Labeler code
67457
Product ID
67457-430_e3a78042-50cb-49d9-a31e-51d8edddbf4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pamidronate Disodium
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA078520
Marketing category
ANDA
Marketing start
2011-05-10
Substance
PAMIDRONATE DISODIUM
Active strength
3 mg/mL
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
Pamidronate Disodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAMIDRONATE DISODIUM3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8742T8ZQZA
Rxcui1737449, 1737453

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0f179c5f-e388-9738-290f-dc1652172ebdProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-430-10Pamidronate Disodium1 in 1 CARTONINJECTION15
67457-430-10Pamidronate Disodium10 mL in 1 VIALINJECTION105

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PAMIDRONATE DISODIUMACTIVE INGREDIENT8742T8ZQZAPAMIDRONATE DISODIUM INJECTION [MYLAN INSTITUTIONAL LLC ]1
PAMIDRONIC ACIDACTIVE MOIETYOYY3447OMCPAMIDRONATE DISODIUM INJECTION [MYLAN INSTITUTIONAL LLC ]1
MANNITOLINACTIVE INGREDIENT3OWL53L36APAMIDRONATE DISODIUM INJECTION [MYLAN INSTITUTIONAL LLC ]1
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNPAMIDRONATE DISODIUM INJECTION [MYLAN INSTITUTIONAL LLC ]1
WATERINACTIVE INGREDIENT059QF0KO0RPAMIDRONATE DISODIUM INJECTION [MYLAN INSTITUTIONAL LLC ]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-430PAMIDRONATE DISODIUM INJECTION [MYLAN INSTITUTIONAL LLC]3Current NDC, Legacy NDC, 2 package rows20231128_c2ca033e-fa5f-4141-b702-11f8b4303da1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737449pamidronate disodium 30 MG in 10 ML InjectionPSNc2ca033e-fa5f-4141-b702-11f8b4303da15
1737453pamidronate disodium 90 MG in 10 ML InjectionPSNc2ca033e-fa5f-4141-b702-11f8b4303da15
173744910 ML pamidronate disodium 3 MG/ML InjectionSCDc2ca033e-fa5f-4141-b702-11f8b4303da15
173745310 ML pamidronate disodium 9 MG/ML InjectionSCDc2ca033e-fa5f-4141-b702-11f8b4303da15
1737449pamidronate disodium 30 MG per 10 ML InjectionSYc2ca033e-fa5f-4141-b702-11f8b4303da15
1737453pamidronate disodium 90 MG per 10 ML InjectionSYc2ca033e-fa5f-4141-b702-11f8b4303da15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-430-10674570430101 VIAL in 1 CARTON (67457-430-10) / 10 mL in 1 VIAL1 vial2011-05-100000-00-00NoNoCurrent