FDA.reportPublic FDA data

VinCRIStine Sulfate

Product NDC
61703-309
11-digit product format
617030309
Labeler code
61703
Product ID
61703-309_436f7772-e507-45ab-be60-4da4e0c889a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VINCRISTINE SULFATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA071484
Marketing category
ANDA
Marketing start
1996-01-01
Substance
VINCRISTINE SULFATE
Active strength
1 mg/mL
Pharmacologic classes
Vinca Alkaloid [EPC], Vinca Alkaloids [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VINCRISTINE SULFATE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT5IRO3534A
Rxcui1863343, 1863354

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
7e304fb5-c83a-2020-74a8-37f17beb19a5Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
e5adc13b-1ed3-2fa3-54b2-9cc5a1e861e7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61703-309-06VinCRIStine Sulfate1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION128
61703-309-06VinCRIStine Sulfate1 in 1 CARTONINJECTION, SOLUTION128
61703-309-16VinCRIStine Sulfate1 in 1 CARTONINJECTION, SOLUTION128
61703-309-16VinCRIStine Sulfate2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION228
61703-309-25VinCRIStine Sulfate1 in 1 CARTONINJECTION, SOLUTION116
61703-309-25VinCRIStine Sulfate2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION216
61703-309-26VinCRIStine Sulfate1 in 1 CARTONINJECTION, SOLUTION116
61703-309-26VinCRIStine Sulfate1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61703-309-06ML - Milliliter61703-309bbefdc0d-50d9-4531-91f5-cdc5ff0b844712012-07-24
61703-309-16ML - Milliliter61703-30907869ec6-0e6e-43cc-9451-227ba7cd0f3312012-07-24
61703-309-25ML - Milliliter61703-309cbb65385-aa01-45c3-bcc0-db9546e010e312014-04-03
61703-309-26ML - Milliliter61703-30956b8b67f-65d8-48c3-9960-f90b9b986fac12014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VINCRISTINE SULFATEACTIVE INGREDIENTT5IRO3534AVINCRISTINE SULFATE INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]13
VINCRISTINEACTIVE MOIETY5J49Q6B70FVINCRISTINE SULFATE INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]13
MANNITOLINACTIVE INGREDIENT3OWL53L36AVINCRISTINE SULFATE INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]13
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IVINCRISTINE SULFATE INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]13
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFVINCRISTINE SULFATE INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]13
WATERINACTIVE INGREDIENT059QF0KO0RVINCRISTINE SULFATE INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61703-309VINCRISTINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]27Current NDC, Legacy NDC, 4 package rows20240501_49596de6-ab18-49d1-9e5b-30968fc21c36.zip
61703-309VINCRISTINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]15Current NDC, Legacy NDC, 4 package rows20240501_b22e4c8e-dbe1-4d4b-a026-e1812974071c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1863343vinCRIStine sulfate 1 MG in 1 ML InjectionPSN49596de6-ab18-49d1-9e5b-30968fc21c3628
1863354vinCRIStine sulfate 2 MG in 2 ML InjectionPSN49596de6-ab18-49d1-9e5b-30968fc21c3628
18633431 ML vincristine sulfate 1 MG/ML InjectionSCD49596de6-ab18-49d1-9e5b-30968fc21c3628
18633542 ML vincristine sulfate 1 MG/ML InjectionSCD49596de6-ab18-49d1-9e5b-30968fc21c3628
18633431 ML VCR Sulfate 1 MG/ML InjectionSY49596de6-ab18-49d1-9e5b-30968fc21c3628
18633542 ML VCR Sulfate 1 MG/ML InjectionSY49596de6-ab18-49d1-9e5b-30968fc21c3628
1863343vincristine sulfate 1 MG per 1 ML InjectionSY49596de6-ab18-49d1-9e5b-30968fc21c3628
1863354vincristine sulfate 2 MG per 2 ML InjectionSY49596de6-ab18-49d1-9e5b-30968fc21c3628
1863343vinCRIStine sulfate 1 MG in 1 ML InjectionPSNb22e4c8e-dbe1-4d4b-a026-e1812974071c16
1863354vinCRIStine sulfate 2 MG in 2 ML InjectionPSNb22e4c8e-dbe1-4d4b-a026-e1812974071c16
18633431 ML vincristine sulfate 1 MG/ML InjectionSCDb22e4c8e-dbe1-4d4b-a026-e1812974071c16
18633542 ML vincristine sulfate 1 MG/ML InjectionSCDb22e4c8e-dbe1-4d4b-a026-e1812974071c16
18633431 ML VCR Sulfate 1 MG/ML InjectionSYb22e4c8e-dbe1-4d4b-a026-e1812974071c16
18633542 ML VCR Sulfate 1 MG/ML InjectionSYb22e4c8e-dbe1-4d4b-a026-e1812974071c16
1863343vincristine sulfate 1 MG per 1 ML InjectionSYb22e4c8e-dbe1-4d4b-a026-e1812974071c16
1863354vincristine sulfate 2 MG per 2 ML InjectionSYb22e4c8e-dbe1-4d4b-a026-e1812974071c16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61703-309-06617030309061 VIAL, SINGLE-DOSE in 1 CARTON (61703-309-06) / 1 mL in 1 VIAL, SINGLE-DOSE1996-01-010000-00-00NoNoCurrent
61703-309-16617030309161 VIAL, SINGLE-DOSE in 1 CARTON (61703-309-16) / 2 mL in 1 VIAL, SINGLE-DOSE1996-01-010000-00-00NoNoCurrent
61703-309-25617030309251 VIAL, SINGLE-DOSE in 1 CARTON (61703-309-25) / 2 mL in 1 VIAL, SINGLE-DOSE2013-11-270000-00-00NoNoCurrent
61703-309-26617030309261 VIAL, SINGLE-DOSE in 1 CARTON (61703-309-26) / 1 mL in 1 VIAL, SINGLE-DOSE2014-02-190000-00-00NoNoCurrent