Home NDC 67046-1581 Phytonadione
Product NDC 67046-1581
11-digit product format 670461581
Labeler code 67046
Product ID 67046-1581_3e4f86c4-7e70-c864-e063-6394a90a59af
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phytonadione
Dosage form TABLET
Route ORAL
Labeler Coupler LLC
Application ANDA210189
Marketing category ANDA
Marketing start 2025-09-08
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 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 A210189-001 PHYTONADIONE PHYTONADIONE 5MG TABLET / ORAL AB RS 2019-02-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210189-001 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.
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 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB RS 2019-02-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB RS 2019-02-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB RS 2019-02-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB RS 2019-02-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB RS 2019-02-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB RS 2019-02-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB RS 2019-02-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB RS 2019-02-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB RS 2019-02-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB RS 2019-02-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB RS 2019-02-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB RS 2019-02-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB RS 2019-02-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB RS 2019-02-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB RS 2019-02-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB 2019-02-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB 2019-02-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB 2019-02-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB 2019-02-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB 2019-02-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB 2019-02-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB 2019-02-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB 2019-02-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB 2019-02-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB 2019-02-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB 2019-02-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB 2019-02-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB 2019-02-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB RS 2019-02-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB RS 2019-02-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB RS 2019-02-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB RS 2019-02-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB RS 2019-02-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB RS 2019-02-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB RS 2019-02-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB RS 2019-02-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB 2019-02-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB 2019-02-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB 2019-02-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210189-001 PHYTONADIONE 5MG TABLET / ORAL AB 2019-02-20 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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHYTONADIONE 5 mg/1
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 198102 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 67046-1581-3 Phytonadione 30 in 1 BLISTER PACK TABLET 30 1
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 · 4 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 67046-1581-3 67046158103 30 TABLET in 1 BLISTER PACK (67046-1581-3) 30 tablet 2025-09-08 No No Current