FDA.reportPublic FDA data

Phytonadione

Product NDC
46708-826
11-digit product format
467080826
Labeler code
46708
Product ID
46708-826_6ccb76ab-1549-4a47-a119-8059588ad83d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phytonadione
Dosage form
INJECTION, EMULSION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA216444
Marketing category
ANDA
Marketing start
2025-09-08
Substance
PHYTONADIONE
Active strength
1 mg/.5mL
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
2026-12-31
Current FDA listing
Yes

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
A216444-001PHYTONADIONEPHYTONADIONE1MG/0.5MLINJECTABLE / INJECTIONAB12025-09-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216444-001AB1

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A216444-001PHYTONADIONE1MG/0.5MLINJECTABLE / INJECTIONAB12025-09-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216444-001PHYTONADIONE1MG/0.5MLINJECTABLE / INJECTIONAB2025-09-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216444-001PHYTONADIONE1MG/0.5MLINJECTABLE / INJECTIONAB2025-09-0831067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216444-001PHYTONADIONE1MG/0.5MLINJECTABLE / INJECTIONAB12025-09-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A216444-001AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216444-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216444-001AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216444-001AB11a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHYTONADIONE1 mg/.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
A034SE7857Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
727625Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6ccb76ab-1549-4a47-a119-8059588ad83dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
16a2c1cd-ae95-d910-f03d-7e06b11dd243Product name520260202
653485de-0601-41e4-82db-7a60bb223e27Product name120251024
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
23fb3cda-2b50-f3d3-ebde-f542350bd77bProduct name420240828
081b54f0-4545-48b6-b854-03e1401f09eaProduct name120230112
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
aead65a2-216e-4ff8-a178-44aab77c24edProduct name120180531
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-826-05Phytonadione1 in 1 CARTONINJECTION, EMULSION11
46708-826-05Phytonadione0.5 mL in 1 SYRINGEINJECTION, EMULSION0.51
46708-826-10Phytonadione0.5 mL in 1 SYRINGEINJECTION, EMULSION0.51
46708-826-10Phytonadione10 in 1 CARTONINJECTION, EMULSION101

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PhytonadionePHYTONADIONESagent Pharmaceuticals3d571642-3d3a-41ae-855e-304ae4fff4592026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216444
application number: ANDA216444
PhytonadionePHYTONADIONEAlembic Pharmaceuticals Limited6ccb76ab-1549-4a47-a119-8059588ad83d2025-09-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216444
application number: ANDA216444
ndc (product): 46708-826
PhytonadionePHYTONADIONEAlembic Pharmaceuticals Inc.b1e53422-c85d-4bb6-af4f-24934cc319b02025-09-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216444
application number: ANDA216444

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727625phytonadione 1 MG in 0.5 ML Prefilled SyringePSN6ccb76ab-1549-4a47-a119-8059588ad83d1
7276250.5 ML vitamin K1 2 MG/ML Prefilled SyringeSCD6ccb76ab-1549-4a47-a119-8059588ad83d1
7276250.5 ML phytonadione 2 MG/ML Prefilled SyringeSY6ccb76ab-1549-4a47-a119-8059588ad83d1
727625phytonadione 1 MG per 0.5 ML Prefilled SyringeSY6ccb76ab-1549-4a47-a119-8059588ad83d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46708-826-05467080826051 SYRINGE in 1 CARTON (46708-826-05) / .5 mL in 1 SYRINGE1 syringe2025-09-08NoNoCurrent
46708-826-104670808261010 SYRINGE in 1 CARTON (46708-826-10) / .5 mL in 1 SYRINGE10 syringe2025-09-08NoNoCurrent