Home NDC 0574-1850 PHYTONADIONE
Product NDC 0574-1850
11-digit product format 005741850
Labeler code 0574
Product ID 0574-1850_68701a07-2921-4443-bff3-76e261a9eb18
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name phytonadione
Dosage form TABLET
Route ORAL
Labeler Padagis US LLC
Application ANDA220454
Marketing category ANDA
Marketing start 2026-10-15
Substance PHYTONADIONE
Active strength 5 mg/1
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 44 .
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 A220454-001 PHYTONADIONE PHYTONADIONE 5MG TABLET / ORAL AB 2026-02-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A220454-001 AB
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 2026-10-15 13:18:30 2026-09 A220454-001 PHYTONADIONE 5MG TABLET / ORAL AB 2026-02-26 c2088c7a36db…2026-09-14 22:38:34 2026-08 A220454-001 PHYTONADIONE 5MG TABLET / ORAL AB 2026-02-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A220454-001 PHYTONADIONE 5MG TABLET / ORAL AB 2026-02-26 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220454-001 PHYTONADIONE 5MG TABLET / ORAL AB 2026-02-26 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0574-1850-30 00574185030 1 BOTTLE in 1 CARTON (0574-1850-30) / 30 TABLET in 1 BOTTLE 1 bottle 2026-10-15 No No Historical