FDA.reportPublic FDA data

Application 010104

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
003MEPHYTONPHYTONADIONETABLET;ORAL5MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N010104-003MEPHYTONPHYTONADIONE5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N010104-003MEPHYTON5MGTABLET / ORALABRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N010104-003MEPHYTON5MGTABLET / ORALABRLD, RS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N010104-003MEPHYTON5MGTABLET / ORALABRLD, RS, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N010104-003MEPHYTON5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982a50c72e98297…

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 ZIP2022-06N010104-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N010104-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N010104-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N010104-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N010104-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N010104-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N010104-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N010104-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N010104-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N010104-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N010104-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N010104-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N010104-003AB1ea99ee380514…
2023-01-26 05:58 UTC2023-01N010104-003AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N010104-003AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N010104-003AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N010104-003AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N010104-003AB1cb3db0bc1861…

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 2 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHYTONADIONEPHYTONADIONEHF Acquisition Co LLC, DBA HealthFirst5686f34b-446a-00ae-e063-6394a90a60292026-08-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE
Vitamin K1PHYTONADIONEHospira, Inc.e8808230-2c44-44c6-8cab-8f29b6b340512026-08-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE
PHYTONADIONEPHYTONADIONESun Pharmaceutical Industries, Inc.51c175dd-02f9-68d1-e063-6294a90a4b362026-04-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE
PHYTONADIONEPHYTONADIONEAmneal Pharmaceuticals Private Limitedddd351d3-8b9e-482d-9ab8-f367ce1c3cc02026-03-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE
PHYTONADIONEPHYTONADIONEOrbicular Pharmaceutical Technologies Private Limitedd954e3d7-a4d5-4798-887d-7af916ff01812026-03-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE
PhytonadionePHYTONADIONEMajor Pharmaceuticals54f23bc8-d8f3-40e8-a93d-3121cc581d542026-03-16Adverse reactionsName fallback
generic name: PHYTONADIONE
PhytonadionePHYTONADIONESagent Pharmaceuticals3d571642-3d3a-41ae-855e-304ae4fff4592026-02-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE
PhytonadionePHYTONADIONEGLENMARK PHARMACEUTICALS INC60e5abd1-e2fa-4a5e-b25b-3ec6cfdeed142025-12-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE
PhytonadionePHYTONADIONEAgnitio Inc.66ada4f8-c5a9-49f1-848f-e172416892a12025-12-01Adverse reactionsName fallback
generic name: PHYTONADIONE
PHYTONADIONEPHYTONADIONEHenry Schein, Inc.1cf90be3-a744-4db5-999d-a84c673723042025-11-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE
PHYTONADIONEPHYTONADIONEHenry Schein, Inc.0d971993-466c-46dd-bdd6-2e300173621e2025-11-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE
phytonadionePHYTONADIONEAmneal Pharmaceuticals LLC2ce1dd90-11ad-4f74-af16-45b7e59f05da2025-10-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE
PhytonadionePHYTONADIONEAlembic Pharmaceuticals Limited6ccb76ab-1549-4a47-a119-8059588ad83d2025-09-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE
PhytonadionePHYTONADIONEAlembic Pharmaceuticals Inc.b1e53422-c85d-4bb6-af4f-24934cc319b02025-09-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE
PhytonadionePHYTONADIONECoupler LLC3e4f86c4-7e89-c864-e063-6394a90a59af2025-09-08Adverse reactionsName fallback
generic name: PHYTONADIONE
PhytonadionePHYTONADIONEXiromed LLCa4b394e7-b766-824e-a8bf-f56808de76e12025-08-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE
PhytonadionePHYTONADIONECaplin Steriles Limited114b1330-6f03-476c-8678-8cd0da189bce2025-04-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE
PhytonadionePHYTONADIONEFresenius Kabi USA, LLC02a39690-38e6-42e9-9897-391c2df9e07e2025-04-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE
PhytonadionePHYTONADIONECipla USA Inc.4bc2de7b-6564-4d77-8a65-6be57b7060932025-01-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE
PhytonadionePHYTONADIONEGland Pharma Limitedc375bfab-5a4b-40f3-a783-8372158af8602024-12-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-1704MephytonphytonadioneBausch Health US LLCNDACurrent
0187-1704MephytonphytonadioneValeant Pharmaceuticals North America LLCNDACurrent
0187-1704MephytonphytonadioneBausch Health US LLCNDACurrent
0187-1704MephytonphytonadioneBausch Health US LLCNDACurrent
0187-1704MephytonphytonadioneBausch Health Americas, Inc.NDACurrent
0187-1704MephytonphytonadioneBausch Health US LLCNDACurrent
21695-168MEPHYTONphytonadioneRebel Distributors CorpNDACurrent
50090-1753MephytonphytonadioneA-S Medication SolutionsNDACurrent
50090-1753MephytonphytonadioneA-S Medication SolutionsNDACurrent
50090-1753MephytonphytonadioneA-S Medication SolutionsNDACurrent
50268-661PhytonadionephytonadioneAvPAKNDA AUTHORIZED GENERICCurrent
68151-0158MephytonphytonadioneCarilion Materials ManagementNDACurrent
68682-170PhytonadionephytonadioneOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-170PhytonadionephytonadioneOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-170PhytonadionephytonadioneOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-170PhytonadionephytonadioneOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-170PhytonadionephytonadioneOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-170PhytonadionephytonadioneOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83117SUPPL 2025-08-18
68128SUPPL2021-07-20
68125SUPPL2021-07-20
52765ORIG2018-02-28
10736SUPPL2012-11-27
11889SUPPL2010-01-26
11888SUPPL2004-03-02