Home NDC 43598-405 PHYTONADIONE
Product NDC 43598-405
11-digit product format 435980405
Labeler code 43598
Product ID 43598-405_c4a2bf44-0ad2-c0d2-164f-562ba6df930c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PHYTONADIONE
Dosage form INJECTION, EMULSION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Dr.Reddy's Laboratories Inc
Application ANDA207719
Marketing category ANDA
Marketing start 2019-05-31
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 A207719-001 PHYTONADIONE PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2019-05-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207719-001 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.
Product history page 1 of 2 · 42 observed 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 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2019-05-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2019-05-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2019-05-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2019-05-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2019-05-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2019-05-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2019-05-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2019-05-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2019-05-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2019-05-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2019-05-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2019-05-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2019-05-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2019-05-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2019-05-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2019-05-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB 2019-05-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB 2019-05-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB 2019-05-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB 2019-05-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB 2019-05-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB 2019-05-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB 2019-05-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB 2019-05-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB 2019-05-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB 2019-05-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB 2019-05-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB 2019-05-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2019-05-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2019-05-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2019-05-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2019-05-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2019-05-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2019-05-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2019-05-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2019-05-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2019-05-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2019-05-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2019-05-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207719-001 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 2019-05-22 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base PHYTONADIONE
Brand name suffix 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 43598-405-11 PHYTONADIONE PHYTONADIONE 1 mL in 1 AMPULE INJECTION, EMULSION 1 5 43598-405-16 PHYTONADIONE PHYTONADIONE 25 in 1 CARTON INJECTION, EMULSION 25 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-405 PHYTONADIONE PHYTONADIONE (PHYTONADIONE) INJECTION, EMULSION [DR.REDDY'S LABORATORIES INC] 5 Current NDC, Legacy NDC, 2 package rows 20220827_02445c07-7b4b-cd70-54e8-ebefc814f547.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PHYTONADIONE PHYTONADIONE HF Acquisition Co LLC, DBA HealthFirst 5686f34b-446a-00ae-e063-6394a90a6029 2026-07-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207719 application number: ANDA207719 PHYTONADIONE PHYTONADIONE Henry Schein, Inc. 1cf90be3-a744-4db5-999d-a84c67372304 2025-11-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207719 application number: ANDA207719 PHYTONADIONE PHYTONADIONE PHYTONADIONE Dr.Reddy's Laboratories Inc 02445c07-7b4b-cd70-54e8-ebefc814f547 2019-05-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207719 application number: ANDA207719 ndc (product): 43598-405
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43598-405-11 43598040511 1 mL in 1 AMPULE 1 ml Historical 43598-405-16 43598040516 25 AMPULE in 1 CARTON (43598-405-16) / 1 mL in 1 AMPULE (43598-405-11) 25 ampule 2019-05-31 0000-00-00 No No Current