FDA.reportPublic FDA data

Pamidronate Disodium

Product NDC
61703-324
11-digit product format
617030324
Labeler code
61703
Product ID
61703-324_d1f55dd9-cc5b-4162-81be-53736ffbb5a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PAMIDRONATE DISODIUM
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA075841
Marketing category
ANDA
Marketing start
2005-10-01
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, 1737451, 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
61703-324-18Pamidronate Disodium1 in 1 CARTONINJECTION, SOLUTION124
61703-324-18Pamidronate Disodium10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61703-324-18ML - Milliliter61703-32424ad2fc8-a56e-419c-828b-15942ab38b4712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PAMIDRONATE DISODIUMACTIVE INGREDIENT8742T8ZQZAPAMIDRONATE DISODIUM INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]13
PAMIDRONIC ACIDACTIVE MOIETYOYY3447OMCPAMIDRONATE DISODIUM INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]13
MANNITOLINACTIVE INGREDIENT3OWL53L36APAMIDRONATE DISODIUM INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]13
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNPAMIDRONATE DISODIUM INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]13
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPAMIDRONATE DISODIUM INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]13
WATERINACTIVE INGREDIENT059QF0KO0RPAMIDRONATE DISODIUM INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61703-324PAMIDRONATE DISODIUM INJECTION, SOLUTION [HOSPIRA, INC.]22Current NDC, Legacy NDC, 2 package rows20250110_9b6a9a3b-71c9-4dcb-b857-5d1de25c3a23.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737449pamidronate disodium 30 MG in 10 ML InjectionPSN9b6a9a3b-71c9-4dcb-b857-5d1de25c3a2324
1737451pamidronate disodium 60 MG in 10 ML InjectionPSN9b6a9a3b-71c9-4dcb-b857-5d1de25c3a2324
1737453pamidronate disodium 90 MG in 10 ML InjectionPSN9b6a9a3b-71c9-4dcb-b857-5d1de25c3a2324
173744910 ML pamidronate disodium 3 MG/ML InjectionSCD9b6a9a3b-71c9-4dcb-b857-5d1de25c3a2324
173745110 ML pamidronate disodium 6 MG/ML InjectionSCD9b6a9a3b-71c9-4dcb-b857-5d1de25c3a2324
173745310 ML pamidronate disodium 9 MG/ML InjectionSCD9b6a9a3b-71c9-4dcb-b857-5d1de25c3a2324
1737449pamidronate disodium 30 MG per 10 ML InjectionSY9b6a9a3b-71c9-4dcb-b857-5d1de25c3a2324
1737451pamidronate disodium 60 MG per 10 ML InjectionSY9b6a9a3b-71c9-4dcb-b857-5d1de25c3a2324
1737453pamidronate disodium 90 MG per 10 ML InjectionSY9b6a9a3b-71c9-4dcb-b857-5d1de25c3a2324

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61703-324-18617030324181 VIAL, SINGLE-DOSE in 1 CARTON (61703-324-18) / 10 mL in 1 VIAL, SINGLE-DOSE2005-10-010000-00-00NoNoCurrent