PHYTONADIONE

Product NDC: 52584-046
11-digit product format: 525840046
Labeler code: 52584
Product ID: 52584-046_ed5403c8-e4f3-406d-bb2c-26d7864246e1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: phytonadione
Dosage form: INJECTION, EMULSION
Route: PARENTERAL
Labeler: General Injectables & Vaccines, Inc
Application: ANDA083722
Marketing category: ANDA
Marketing start: 2014-01-06
Marketing end: 2023-08-31
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: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	52584-046		D	Discontinued by firm		2026-08-03
excluded package	package	52584-046	52584-046-01	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52584-046-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52584-046-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52584-046-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52584-046-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52584-046-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52584-046-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52584-046-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52584-046-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52584-046-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52584-046-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52584-046-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52584-046-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A083722-001	PHYTONADIONE	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	AB1	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A083722-001	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	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A083722-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083722-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083722-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083722-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083722-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083722-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083722-001	BP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083722-001	BP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083722-001	BP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083722-001	BP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083722-001	BP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083722-001	BP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083722-001	BP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083722-001	BP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083722-001	BP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083722-001	BP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083722-001	BP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083722-001	BP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083722-001	BP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083722-001	BP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083722-001	BP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A083722-001	BP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A083722-001	BP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A083722-001	BP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A083722-001	BP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A083722-001	BP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A083722-001	BP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083722-001	BP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A083722-001	BP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A083722-001	BP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083722-001	BP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083722-001	BP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083722-001	BP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A083722-001	BP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A083722-001	BP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A083722-001	BP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A083722-001	BP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A083722-001	BP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A083722-001	BP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A083722-001	BP	1	`cb3db0bc1861…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
PHYTONADIONE	ACTIVE INGREDIENT	A034SE7857	PHYTONADIONE INJECTION, EMULSION [GENERAL INJECTABLES & VACCINES, INC]	1
PHYTONADIONE	ACTIVE MOIETY	A034SE7857	PHYTONADIONE INJECTION, EMULSION [GENERAL INJECTABLES & VACCINES, INC]	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PHYTONADIONE	PHYTONADIONE	Henry Schein, Inc.	0d971993-466c-46dd-bdd6-2e300173621e	2025-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083722 application number: ANDA083722
Phytonadione	PHYTONADIONE	International Medication Systems, Limited	e0b0c8f1-75be-4f25-898a-7b97b608c615	2024-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083722 application number: ANDA083722

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
A034SE7857	PHYTONADIONE	PHYTONADIONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52584-046-01	52584004601	1 BOX in 1 BAG (52584-046-01) > 1 SYRINGE in 1 BOX > .5 mL in 1 SYRINGE	1 box	2014-01-06	0000-00-00	No	No	Current