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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071484-001VINCRISTINE SULFATE PFSVINCRISTINE SULFATE1MG/MLINJECTABLE / INJECTIONRS1988-04-19

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONRS1988-04-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONRS1988-04-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONRS1988-04-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONRS1988-04-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONRS1988-04-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONRS1988-04-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONRS1988-04-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONRS1988-04-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONRS1988-04-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONRS1988-04-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONRS1988-04-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONRS1988-04-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONRS1988-04-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONRS1988-04-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONAPRS1988-04-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONAPRS1988-04-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONAPRS1988-04-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONRS1988-04-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONAPRS1988-04-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONAPRS1988-04-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONAPRS1988-04-1987673890dc5c…
2021-03-12 10:30 UTC2021-03A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONAPRS1988-04-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONAPRS1988-04-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONAPRS1988-04-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONRS1988-04-193f01610625f2…
2019-09-15 20:21 UTC2019-09A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONAPRS1988-04-19b00525d2431f…
2019-07-19 19:46 UTC2019-07A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONAPRS1988-04-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONRS1988-04-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONRS1988-04-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONRS1988-04-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONRS1988-04-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONRS1988-04-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONAPRS1988-04-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONAPRS1988-04-193f0d92c62455…
2023-05-13 08:27 UTC2023-05A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONAPRS1988-04-19053a50430f4f…
2023-01-26 05:58 UTC2023-01A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONAPRS1988-04-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONAPRS1988-04-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONAPRS1988-04-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONAPRS1988-04-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071484-001VINCRISTINE SULFATE PFS1MG/MLINJECTABLE / INJECTIONAPRS1988-04-19cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071484-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071484-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071484-001AP14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A071484-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071484-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071484-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A071484-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071484-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071484-001AP1c0c555d07b60…
2019-09-15 20:21 UTC2019-09A071484-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A071484-001AP1ea99ee380514…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071484-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071484-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A071484-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A071484-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071484-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071484-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071484-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071484-001AP1cb3db0bc1861…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
T5IRO3534AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1863343Internal RxNorm lookup
1863354Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
49596de6-ab18-49d1-9e5b-30968fc21c36Available on FDA.report

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#

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VinCRIStine SulfateVINCRISTINE SULFATEHospira, Inc.b22e4c8e-dbe1-4d4b-a026-e1812974071c2026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071484
application number: ANDA071484
ndc (product): 61703-309
VinCRIStine SulfateVINCRISTINE SULFATEHospira, Inc.49596de6-ab18-49d1-9e5b-30968fc21c362025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071484
application number: ANDA071484
ndc (product): 61703-309

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