Home NDC 43598-032 Phytonadione
Product NDC 43598-032
11-digit product format 435980032
Labeler code 43598
Product ID 43598-032_8f00bc47-096d-2653-7d8c-df3bd0db06c7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phytonadione
Dosage form INJECTION, EMULSION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Dr.Reddys Laboratories Inc
Application ANDA215820
Marketing category ANDA
Marketing start 2026-10-05
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 A215820-001 PHYTONADIONE PHYTONADIONE 1MG/0.5ML INJECTABLE / INJECTION AB1 2026-05-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215820-001 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 A215820-001 PHYTONADIONE 1MG/0.5ML INJECTABLE / INJECTION AB1 2026-05-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215820-001 PHYTONADIONE 1MG/0.5ML INJECTABLE / INJECTION AB1 2026-05-15 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215820-001 PHYTONADIONE 1MG/0.5ML INJECTABLE / INJECTION AB1 2026-05-15 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 A215820-001 AB1 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215820-001 AB1 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215820-001 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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 43598-032-37 43598003237 10 CARTON in 1 BOX (43598-032-37) / 1 SYRINGE, GLASS in 1 CARTON (43598-032-11) / .5 mL in 1 SYRINGE, GLASS 10 carton 2026-10-05 No No Current