Paclitaxel

Product NDC
61703-342
11-digit product format
617030342
Labeler code
61703
Product ID
61703-342_f4f04a49-a3f6-40cd-b261-aa889a0b7d0d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PACLITAXEL
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA076131
Marketing category
ANDA
Marketing start
2004-03-01
Substance
PACLITAXEL
Active strength
6 mg/mL
Pharmacologic classes
Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Paclitaxel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PACLITAXEL6 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP88XT4IS4D
Rxcui312199

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9bfd8626-d4ce-43ae-acb3-8de37f80302fProduct name320260126
2cc1dc98-28db-3a82-b37e-4e50de7c4f94Product name520240102
a05831c4-07a7-44ad-9dc5-89391450ee82Product name120230323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61703-342-092024-01-30C16284748780-11030e365-5e4b-111a-e063-dadaa90a10e2Paclitaxel
61703-342-222024-01-30C16284748780-11030e365-5e4b-111a-e063-dadaa90a10e2Paclitaxel
61703-342-502024-01-30C16284748780-11030e365-5e4b-111a-e063-dadaa90a10e2Paclitaxel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61703-342-09Paclitaxel5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION532
61703-342-09Paclitaxel1 in 1 CARTONINJECTION, SOLUTION132
61703-342-22Paclitaxel16.7 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION16.732
61703-342-22Paclitaxel1 in 1 CARTONINJECTION, SOLUTION132
61703-342-50Paclitaxel1 in 1 CARTONINJECTION, SOLUTION132
61703-342-50Paclitaxel50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION5032

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61703-342-09ML - Milliliter61703-342929c4e86-6531-4e7b-ab31-712a6523274a12012-07-24
61703-342-22ML - Milliliter61703-342669eefaa-ccf3-4018-935a-432c4168422612012-07-24
61703-342-50ML - Milliliter61703-3427e1ee991-ceff-48cc-8d41-31210717e43312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PACLITAXELACTIVE INGREDIENTP88XT4IS4DPACLITAXEL INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]18
PACLITAXELACTIVE MOIETYP88XT4IS4DPACLITAXEL INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]18
ALCOHOLINACTIVE INGREDIENT3K9958V90MPACLITAXEL INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]18
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPACLITAXEL INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]18
POLYOXYL 35 CASTOR OILINACTIVE INGREDIENT6D4M1DAL6OPACLITAXEL INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61703-342PACLITAXEL INJECTION, SOLUTION [HOSPIRA, INC.]32Current NDC, Legacy NDC, 6 package rows20250410_ea28753a-8631-460a-bfdc-b101eb8ac84a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312199PACLitaxel 6 MG/ML Injectable SolutionPSNea28753a-8631-460a-bfdc-b101eb8ac84a32
312199paclitaxel 6 MG/ML Injectable SolutionSCDea28753a-8631-460a-bfdc-b101eb8ac84a32
312199paclitaxel 100 MG per 16.7 ML Injectable SolutionSYea28753a-8631-460a-bfdc-b101eb8ac84a32
312199paclitaxel 150 MG per 25 ML Injectable SolutionSYea28753a-8631-460a-bfdc-b101eb8ac84a32
312199paclitaxel 30 MG per 5 ML Injectable SolutionSYea28753a-8631-460a-bfdc-b101eb8ac84a32
312199paclitaxel 300 MG per 50 ML Injectable SolutionSYea28753a-8631-460a-bfdc-b101eb8ac84a32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61703-342-09617030342091 VIAL, MULTI-DOSE in 1 CARTON (61703-342-09) / 5 mL in 1 VIAL, MULTI-DOSE2004-03-010000-00-00NoNoCurrent
61703-342-22617030342221 VIAL, MULTI-DOSE in 1 CARTON (61703-342-22) / 16.7 mL in 1 VIAL, MULTI-DOSE2004-03-010000-00-00NoNoCurrent
61703-342-50617030342501 VIAL, MULTI-DOSE in 1 CARTON (61703-342-50) / 50 mL in 1 VIAL, MULTI-DOSE2004-03-010000-00-00NoNoCurrent