FDA.reportPublic FDA data

PHYTONADIONE

Product NDC
70095-154
Requested package NDC
70095-154-02
11-digit product format
700950154
Labeler code
70095
Product ID
70095-154_529e577c-78f0-54c6-e063-6394a90af94f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phytonadione
Dosage form
INJECTION, EMULSION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA216298
Marketing category
ANDA
Marketing start
2026-06-10
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 43.

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
A216298-001PHYTONADIONEPHYTONADIONE1MG/0.5MLINJECTABLE / INJECTIONAB12026-03-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216298-001AB1

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
2026-09-14 22:38:342026-08A216298-001PHYTONADIONE1MG/0.5MLINJECTABLE / INJECTIONAB12026-03-1384e616aacf4f…
2026-08-18 06:07:402026-07A216298-001PHYTONADIONE1MG/0.5MLINJECTABLE / INJECTIONAB12026-03-13caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216298-001PHYTONADIONE1MG/0.5MLINJECTABLE / INJECTIONAB12026-03-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A216298-001AB1184e616aacf4f…
2026-08-18 06:07:402026-07A216298-001AB11caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216298-001AB11a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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

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
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
51c175dd-02f9-68d1-e063-6294a90a4b36Available on FDA.report

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
PHYTONADIONEPHYTONADIONESun Pharmaceutical Industries, Inc.51c175dd-02f9-68d1-e063-6294a90a4b362026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216298
application number: ANDA216298
ndc (package): 70095-154-02
ndc (product): 70095-154
ndc11 (package): 70095015402
PHYTONADIONEPHYTONADIONEOrbicular Pharmaceutical Technologies Private Limitedd954e3d7-a4d5-4798-887d-7af916ff01812026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216298
application number: ANDA216298

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70095-154-027009501540210 CARTON in 1 CARTON (70095-154-02) / 1 BLISTER PACK in 1 CARTON (70095-154-01) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE10 carton2026-06-10NoNoCurrent