Vitamin K1

Product NDC
50090-4523
11-digit product format
500904523
Labeler code
50090
Product ID
50090-4523_ab171dc2-3781-4368-99c4-5aabb716934a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHYTONADIONE
Dosage form
INJECTION, EMULSION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
A-S Medication Solutions
Application
ANDA087954
Marketing category
ANDA
Marketing start
2005-06-22
Marketing end
0000-00-00
Substance
PHYTONADIONE
Active strength
2 mg/mL
Pharmacologic classes
Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [CS],Vitamin K [EPC],Warfarin Reversal Agent [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-4523IInactivated by FDA2026-08-17
excluded packagepackage50090-452350090-4523-0IInactivated by FDA2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-4523-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-4523-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-4523-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-4523-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-4523-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-4523-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-4523-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-4523-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-4523-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-4523-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-4523-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-4523-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-4523-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-4523-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-4523-01332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A087954-001VITAMIN K1PHYTONADIONE1MG/0.5MLINJECTABLE / INJECTIONBPRLD, RS1983-07-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A087954-001BP

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRLD, RS1983-07-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRLD, RS1983-07-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRLD, RS1983-07-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRLD, RS1983-07-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRLD, RS1983-07-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRLD, RS1983-07-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRLD, RS1983-07-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRLD, RS1983-07-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRLD, RS1983-07-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRLD, RS1983-07-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRLD, RS1983-07-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRLD, RS1983-07-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRLD, RS1983-07-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRLD, RS1983-07-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRLD, RS1983-07-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRLD, RS1983-07-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRLD, RS1983-07-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRLD, RS1983-07-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRS1983-07-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRLD, RS1983-07-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRLD, RS1983-07-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRS1983-07-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRS1983-07-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRS1983-07-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRS1983-07-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRS1983-07-253f01610625f2…
2019-09-15 20:21 UTC2019-09A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRS1983-07-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRS1983-07-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRLD, RS1983-07-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRLD, RS1983-07-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRLD, RS1983-07-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRLD, RS1983-07-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRLD, RS1983-07-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRLD, RS1983-07-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRLD, RS1983-07-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRLD, RS1983-07-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRLD, RS1983-07-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRLD, RS1983-07-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRLD, RS1983-07-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087954-001VITAMIN K11MG/0.5MLINJECTABLE / INJECTIONBPRLD, RS1983-07-25e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A087954-001BP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A087954-001BP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087954-001BP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A087954-001BP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087954-001BP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087954-001BP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087954-001BP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087954-001BP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087954-001BP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087954-001BP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087954-001BP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087954-001BP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087954-001BP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087954-001BP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087954-001BP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087954-001BP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087954-001BP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087954-001BP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087954-001BP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087954-001BP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087954-001BP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087954-001BP187673890dc5c…
2021-03-12 10:30 UTC2021-03A087954-001BP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087954-001BP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087954-001BP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087954-001BP13f01610625f2…
2019-09-15 20:21 UTC2019-09A087954-001BP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A087954-001BP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087954-001BP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087954-001BP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087954-001BP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087954-001BP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087954-001BP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087954-001BP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087954-001BP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A087954-001BP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A087954-001BP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087954-001BP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087954-001BP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087954-001BP1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
16a2c1cd-ae95-d910-f03d-7e06b11dd243Product name520260202
653485de-0601-41e4-82db-7a60bb223e27Product name120251024
23fb3cda-2b50-f3d3-ebde-f542350bd77bProduct name420240828
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
081b54f0-4545-48b6-b854-03e1401f09eaProduct name120230112
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
aead65a2-216e-4ff8-a178-44aab77c24edProduct name120180531
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4523-02023-01-30C16284748780-1f386c649-cbbd-0266-e053-dadaa90a7c1aVITAMIN K 1 INJECTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4523-0Vitamin K1.5 mL in 1 AMPULEINJECTION, EMULSION.58

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4523VITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [A-S MEDICATION SOLUTIONS]8Legacy NDC, 1 package rows20210615_f922f301-f5ab-4db8-b6a6-364f95fff09c.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
Vitamin K1PHYTONADIONEHospira, Inc.e8808230-2c44-44c6-8cab-8f29b6b340512026-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087954
application number: ANDA087954
VITAMIN K1 PHYTONADIONEVITAMIN K1, PHYTONADIONEHF Acquisition Co LLC, DBA HealthFirstcfc0df9f-ee59-9e30-e053-2995a90ad4492026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087954
application number: ANDA087954

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312424phytonadione 1 MG in 0.5 ML InjectionPSNf922f301-f5ab-4db8-b6a6-364f95fff09c8
3124240.5 ML vitamin K1 2 MG/ML InjectionSCDf922f301-f5ab-4db8-b6a6-364f95fff09c8
312424phytonadione 1 MG per 0.5 ML InjectionSYf922f301-f5ab-4db8-b6a6-364f95fff09c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4523-050090452300.5 mL in 1 AMPULE (50090-4523-0) 2019-09-130000-00-00NoNoCurrent