FDA.reportPublic FDA data

PHYTONADIONE

Product NDC
43066-132
11-digit product format
430660132
Labeler code
43066
Product ID
43066-132_98fa1675-8af1-42c5-bbab-8b3632d52a0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHYTONADIONE
Dosage form
INJECTION, EMULSION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Baxter Healthcare Corporation
Application
ANDA216852
Marketing category
ANDA
Marketing start
2026-02-26
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
2027-12-31
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
A216852-001PHYTONADIONEPHYTONADIONE1MG/0.5MLINJECTABLE / INJECTIONAB22026-02-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216852-001AB2

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 06:07:402026-07A216852-001PHYTONADIONE1MG/0.5MLINJECTABLE / INJECTIONAB22026-02-26caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216852-001PHYTONADIONE1MG/0.5MLINJECTABLE / INJECTIONAB22026-02-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A216852-001AB21caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216852-001AB21a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
PHYTONADIONE
Listing expiration
2027-12-31

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
312424Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
98fa1675-8af1-42c5-bbab-8b3632d52a0fAvailable 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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43066-132-10PHYTONADIONE10 in 1 CARTONINJECTION, EMULSION101
43066-132-10PHYTONADIONE0.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, EMULSION0.51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43066-132-10ML - Milliliter43066-1324e70e035-3890-4709-af74-43b77407184912026-04-20

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHYTONADIONEPHYTONADIONEBaxter Healthcare Corporation98fa1675-8af1-42c5-bbab-8b3632d52a0f2023-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216852
application number: ANDA216852
ndc (product): 43066-132

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312424phytonadione 1 MG in 0.5 ML InjectionPSN98fa1675-8af1-42c5-bbab-8b3632d52a0f1
3124240.5 ML vitamin K1 2 MG/ML InjectionSCD98fa1675-8af1-42c5-bbab-8b3632d52a0f1
312424phytonadione 1 MG per 0.5 ML InjectionSY98fa1675-8af1-42c5-bbab-8b3632d52a0f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
43066-132-104306601321010 VIAL, SINGLE-DOSE in 1 CARTON (43066-132-10) / .5 mL in 1 VIAL, SINGLE-DOSE2026-02-26NoNoCurrent