Home NDC 0409-9158-25 Vitamin K1
Product NDC 0409-9158
Requested package NDC 0409-9158-25
11-digit product format 004099158
Labeler code 0409
Product ID 0409-9158_42b6397b-1ec3-4182-95cf-e2dfe5c19a28
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PHYTONADIONE
Dosage form INJECTION, EMULSION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Hospira, Inc.
Application ANDA087955
Marketing category ANDA
Marketing start 2005-07-27
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 1 .
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 A087955-001 VITAMIN K1 PHYTONADIONE 10MG/ML INJECTABLE / INJECTION AB1 RLD, RS 1983-07-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A087955-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB1 RLD, RS 1983-07-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB1 RLD, RS 1983-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB1 RLD, RS 1983-07-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB1 RLD, RS 1983-07-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB1 RLD, RS 1983-07-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB1 RLD, RS 1983-07-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB1 RLD, RS 1983-07-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB1 RLD, RS 1983-07-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB1 RLD, RS 1983-07-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB1 RLD, RS 1983-07-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB1 RLD, RS 1983-07-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB1 RLD, RS 1983-07-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB1 RLD, RS 1983-07-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB1 RLD, RS 1983-07-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB1 RLD, RS 1983-07-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB RLD, RS 1983-07-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB RLD, RS 1983-07-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB RS 1983-07-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB RLD, RS 1983-07-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB RLD, RS 1983-07-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB RS 1983-07-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB RS 1983-07-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB RS 1983-07-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB RS 1983-07-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB RS 1983-07-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB RS 1983-07-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB RS 1983-07-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB1 RLD, RS 1983-07-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB1 RLD, RS 1983-07-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB1 RLD, RS 1983-07-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB1 RLD, RS 1983-07-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB1 RLD, RS 1983-07-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB1 RLD, RS 1983-07-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB1 RLD, RS 1983-07-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB1 RLD, RS 1983-07-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB1 RLD, RS 1983-07-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB1 RLD, RS 1983-07-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB1 RLD, RS 1983-07-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB1 RLD, RS 1983-07-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A087955-001 VITAMIN K1 10MG/ML INJECTABLE / INJECTION AB1 RLD, RS 1983-07-25 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Vitamin K1
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312424 Internal RxNorm lookup 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 0409-9158-01 Vitamin K1 5 in 1 CONTAINER INJECTION, EMULSION 5 22 0409-9158-11 Vitamin K1 1 mL in 1 AMPULE INJECTION, EMULSION 1 22 0409-9158-25 Vitamin K1 5 in 1 CONTAINER INJECTION, EMULSION 5 22 0409-9158-31 Vitamin K1 1 mL in 1 AMPULE INJECTION, EMULSION 1 22 0409-9158-50 Vitamin K1 5 in 1 TRAY INJECTION, EMULSION 5 22 0409-9158-55 Vitamin K1 5 in 1 TRAY INJECTION, EMULSION 5 22
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PHYTONADIONE ACTIVE INGREDIENT A034SE7857 VITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [HOSPIRA, INC.] 12 PHYTONADIONE ACTIVE MOIETY A034SE7857 VITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [HOSPIRA, INC.] 12 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH VITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [HOSPIRA, INC.] 12 DEXTROSE MONOHYDRATE INACTIVE INGREDIENT LX22YL083G VITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [HOSPIRA, INC.] 12 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB VITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [HOSPIRA, INC.] 12 POLYOXYL 35 CASTOR OIL INACTIVE INGREDIENT 6D4M1DAL6O VITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [HOSPIRA, INC.] 12 WATER INACTIVE INGREDIENT 059QF0KO0R VITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [HOSPIRA, INC.] 12 Phytonadione ACTIVE INGREDIENT A034SE7857 VITAMIN K1 (PHYTONADIONE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC] 1 Phytonadione ACTIVE MOIETY A034SE7857 VITAMIN K1 (PHYTONADIONE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-9158 VITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [HOSPIRA, INC.] 20 Current NDC, Legacy NDC, 6 package rows 20241207_e8808230-2c44-44c6-8cab-8f29b6b34051.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 Marketing end Sample Exclude flag Status 0409-9158-25 00409915825 5 TRAY in 1 CONTAINER (0409-9158-25) / 5 AMPULE in 1 TRAY (0409-9158-55) / 1 mL in 1 AMPULE (0409-9158-11) 5 tray 2021-01-15 0000-00-00 No No Current