Home NDC 65219-635 Phytonadione
Product NDC 65219-635
11-digit product format 652190635
Labeler code 65219
Product ID 65219-635_02a39690-38e6-42e9-9897-391c2df9e07e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phytonadione
Dosage form INJECTION, EMULSION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA219212
Marketing category ANDA
Marketing start 2025-05-10
Substance PHYTONADIONE
Active strength 10 mg/mL
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219212-001 PHYTONADIONE PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2025-04-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219212-001 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 2026-08-18 06:07:40 2026-07 A219212-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2025-04-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219212-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2025-04-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219212-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2025-04-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219212-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2025-04-17 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219212-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2025-04-17 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Phytonadione
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHYTONADIONE 10 mg/mL
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 1670192 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65219-635-00 Phytonadione 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, EMULSION 1 1 65219-635-00 Phytonadione 5 in 1 TRAY INJECTION, EMULSION 5 1 65219-635-01 Phytonadione 2 in 1 CARTON INJECTION, EMULSION 2 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65219-635 PHYTONADIONE INJECTION, EMULSION [FRESENIUS KABI USA, LLC] 1 Current NDC, 3 package rows 20250511_02a39690-38e6-42e9-9897-391c2df9e07e.zip
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 65219-635-00 65219063500 1 mL in 1 VIAL, SINGLE-DOSE 1 ml Historical 65219-635-01 65219063501 2 TRAY in 1 CARTON (65219-635-01) / 5 VIAL, SINGLE-DOSE in 1 TRAY (65219-635-00) / 1 mL in 1 VIAL, SINGLE-DOSE 2 tray 2025-05-10 No No Current