Phytonadione

Product NDC: 16714-973
Requested package NDC: 16714-973-01
11-digit product format: 167140973
Labeler code: 16714
Product ID: 16714-973_36fd9f1d-be83-4b1f-bf3d-149b3c942af8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phytonadione
Dosage form: TABLET
Route: ORAL
Labeler: Northstar Rx LLC.
Application: ANDA210189
Marketing category: ANDA
Marketing start: 2022-03-22
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	16714-973	16714-973-01	D	Discontinued by firm		2026-08-17

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 · 12 matching rows.

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

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

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A210189-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210189-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210189-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210189-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210189-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210189-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210189-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210189-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210189-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210189-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210189-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210189-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210189-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210189-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210189-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210189-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210189-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210189-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210189-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210189-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210189-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210189-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210189-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210189-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210189-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210189-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210189-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210189-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210189-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210189-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210189-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210189-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210189-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210189-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210189-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210189-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210189-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210189-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210189-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210189-001	AB	1	`e64feba35796…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5429b58b-ec2b-4a18-95d9-a9d804321192	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
16a2c1cd-ae95-d910-f03d-7e06b11dd243	Product name	5	20260202
653485de-0601-41e4-82db-7a60bb223e27	Product name	1	20251024
23fb3cda-2b50-f3d3-ebde-f542350bd77b	Product name	4	20240828
081b54f0-4545-48b6-b854-03e1401f09ea	Product name	1	20230112
aead65a2-216e-4ff8-a178-44aab77c24ed	Product name	1	20180531

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16714-973-01	Phytonadione	100 in 1 BOTTLE	TABLET	100	5
16714-973-01	Phytonadione	1 in 1 CARTON	TABLET	1	5
16714-973-02	Phytonadione	1 in 1 CARTON	TABLET	1	5
16714-973-02	Phytonadione	30 in 1 BOTTLE	TABLET	30	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-973-01	EA - Each	16714-973	941bbb14-b501-4bf3-bd4a-59bb10d4e5f6	1	2019-12-10
16714-973-02	EA - Each	16714-973	d7e343a1-6943-4270-be0c-2ef7c91849c1	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-973	PHYTONADIONE TABLET [NORTHSTAR RX LLC.]	5	Current NDC, Legacy NDC, 4 package rows	20240806_5429b58b-ec2b-4a18-95d9-a9d804321192.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phytonadione	PHYTONADIONE	Coupler LLC	3e4f86c4-7e89-c864-e063-6394a90a59af	2025-09-08	Adverse reactions	Exact identifier application applno (ANDA): 210189 application number: ANDA210189
Phytonadione	PHYTONADIONE	Northstar Rx LLC.	5429b58b-ec2b-4a18-95d9-a9d804321192	2024-08-05	Adverse reactions	Exact identifier application applno (ANDA): 210189 application number: ANDA210189 ndc (package): 16714-973-01 ndc (product): 16714-973 ndc11 (package): 16714097301
Phytonadione	PHYTONADIONE	Zydus Pharmaceuticals USA Inc.	6c992275-b040-42d0-9eff-570dce4272fe	2024-08-05	Adverse reactions	Exact identifier application applno (ANDA): 210189 application number: ANDA210189
Phytonadione	PHYTONADIONE	Zydus Lifesciences Limited	fa26f747-c64e-4090-a0cf-de3d3d9b004c	2022-11-01		Exact identifier application applno (ANDA): 210189 application number: ANDA210189

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198102	phytonadione 5 MG Oral Tablet	PSN	5429b58b-ec2b-4a18-95d9-a9d804321192	5
198102	vitamin K1 5 MG Oral Tablet	SCD	5429b58b-ec2b-4a18-95d9-a9d804321192	5
198102	phytonadione 5 MG Oral Tablet	SY	5429b58b-ec2b-4a18-95d9-a9d804321192	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-973-01	16714097301	1 BOTTLE in 1 CARTON (16714-973-01) > 100 TABLET in 1 BOTTLE	1 bottle	2022-03-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phytonadione	Northstar Rx LLC. \| Zydus Lifesciences Global FZE \| Zydus Lifesciences Limited	2024-08-05	HUMAN PRESCRIPTION DRUG LABEL	5