Home NDC 51662-1537 VITAMIN K1 PHYTONADIONE
Product NDC 51662-1537
11-digit product format 516621537
Labeler code 51662
Product ID 51662-1537_1034dbd2-6cd0-dd97-e063-6294a90a19b1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name VITAMIN K1, PHYTONADIONE
Dosage form INJECTION, EMULSION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler HF Acquisition Co LLC, DBA HealthFirst
Application ANDA087954
Marketing category ANDA
Marketing start 2021-11-01
Substance PHYTONADIONE
Active strength 2 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 A087954-001 VITAMIN K1 PHYTONADIONE 1MG/0.5ML INJECTABLE / INJECTION BP 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 A087954-001 BP
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 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RLD, RS 1983-07-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RLD, RS 1983-07-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RLD, RS 1983-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RLD, RS 1983-07-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RLD, RS 1983-07-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RLD, RS 1983-07-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RLD, RS 1983-07-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RLD, RS 1983-07-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RLD, RS 1983-07-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RLD, RS 1983-07-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RLD, RS 1983-07-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RLD, RS 1983-07-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RLD, RS 1983-07-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RLD, RS 1983-07-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RLD, RS 1983-07-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RLD, RS 1983-07-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RLD, RS 1983-07-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RLD, RS 1983-07-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RS 1983-07-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RLD, RS 1983-07-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RLD, RS 1983-07-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RS 1983-07-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RS 1983-07-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RS 1983-07-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RS 1983-07-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RS 1983-07-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RS 1983-07-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RS 1983-07-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RLD, RS 1983-07-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RLD, RS 1983-07-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RLD, RS 1983-07-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RLD, RS 1983-07-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RLD, RS 1983-07-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RLD, RS 1983-07-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RLD, RS 1983-07-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RLD, RS 1983-07-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RLD, RS 1983-07-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RLD, RS 1983-07-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RLD, RS 1983-07-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A087954-001 VITAMIN K1 1MG/0.5ML INJECTABLE / INJECTION BP RLD, RS 1983-07-25 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 VITAMIN K1 PHYTONADIONE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHYTONADIONE 2 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 312424 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 51662-1537-2 VITAMIN K1 PHYTONADIONE 0.5 mL in 1 AMPULE INJECTION, EMULSION 0.5 3 51662-1537-2 VITAMIN K1 PHYTONADIONE 1 in 1 POUCH INJECTION, EMULSION 1 3 51662-1537-3 VITAMIN K1 PHYTONADIONE 25 in 1 BOX INJECTION, EMULSION 25 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51662-1537 VITAMIN K1 PHYTONADIONE (VITAMIN K1, PHYTONADIONE) INJECTION, EMULSION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] 3 Current NDC, Legacy NDC, 3 package rows 20240201_cfc0df9f-ee59-9e30-e053-2995a90ad449.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 51662-1537-2 51662153702 0.5 mL in 1 AMPULE 0.5 ml Historical 51662-1537-3 51662153703 25 POUCH in 1 BOX (51662-1537-3) / 1 AMPULE in 1 POUCH (51662-1537-2) / .5 mL in 1 AMPULE 25 pouch 2021-11-01 0000-00-00 No No Current