Home NDC 70700-331 Phytonadione
Product NDC 70700-331
11-digit product format 707000331
Labeler code 70700
Product ID 70700-331_2151937d-2482-d1f1-fbb4-08df466c26a0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phytonadione
Dosage form INJECTION, EMULSION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Xiromed LLC
Application ANDA217386
Marketing category ANDA
Marketing start 2025-08-28
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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217386-001 PHYTONADIONE PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2024-12-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217386-001 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 A217386-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2024-12-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217386-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2024-12-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217386-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2024-12-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217386-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2024-12-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217386-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2024-12-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217386-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2024-12-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217386-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2024-12-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217386-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2024-12-10 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217386-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2024-12-10 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Phytonadione
Listing expiration 2027-12-31 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 70700-331-24 Phytonadione 5 in 1 TRAY INJECTION, EMULSION 5 2 70700-331-24 Phytonadione 1 mL in 1 AMPULE INJECTION, EMULSION 1 2 70700-331-25 Phytonadione 5 in 1 CARTON INJECTION, EMULSION 5 2
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 · 3 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 70700-331-24 70700033124 5 in 1 TRAY Historical 70700-331-25 70700033125 5 TRAY in 1 CARTON (70700-331-25) / 5 AMPULE in 1 TRAY (70700-331-24) / 1 mL in 1 AMPULE 5 tray 2025-08-28 No No Current