Home NDC 70095-154 PHYTONADIONE
Product NDC 70095-154
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216298-001 PHYTONADIONE PHYTONADIONE 1MG/0.5ML INJECTABLE / INJECTION AB1 2026-03-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216298-001 AB1
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A216298-001 PHYTONADIONE 1MG/0.5ML INJECTABLE / INJECTION AB1 2026-03-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216298-001 PHYTONADIONE 1MG/0.5ML INJECTABLE / INJECTION AB1 2026-03-13 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216298-001 PHYTONADIONE 1MG/0.5ML INJECTABLE / INJECTION AB1 2026-03-13 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A216298-001 AB1 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216298-001 AB1 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216298-001 AB1 1 a50c72e98297…
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 Ingredient Strength PHYTONADIONE 1 mg/.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination A034SE7857 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 727625 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70095-154-02 70095015402 10 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 SYRINGE 10 carton 2026-06-10 No No Current