Phytonadione

Product NDC: 69238-1051
11-digit product format: 692381051
Labeler code: 69238
Product ID: 69238-1051_94d89db9-981d-4fc5-b6fe-5d4b73230e35
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phytonadione
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals NY LLC
Application: ANDA209373
Marketing category: ANDA
Marketing start: 2018-05-15
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

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product	69238-1051		I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69238-1051	69238-1051-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69238-1051	69238-1051-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

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
A209373-001	PHYTONADIONE	PHYTONADIONE	5MG	TABLET / ORAL	AB		2018-05-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209373-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`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	A209373-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209373-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209373-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209373-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209373-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209373-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209373-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209373-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209373-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209373-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209373-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209373-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209373-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209373-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209373-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209373-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209373-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209373-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209373-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209373-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209373-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209373-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209373-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209373-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209373-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209373-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209373-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209373-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209373-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209373-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209373-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209373-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209373-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209373-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209373-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209373-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209373-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209373-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209373-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209373-001	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
54c1c1df-0e65-4da8-9023-6cbaa0f5bd0d	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
081b54f0-4545-48b6-b854-03e1401f09ea	Product name	1	20230112
aead65a2-216e-4ff8-a178-44aab77c24ed	Product name	1	20180531

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
69238-1051-1	2024-04-26	These highlights do not include all the information needed to use PHYTONADIONE TABLETS safely and effectively. See full prescribing information for PHYTONADIONE TABLETS. PHYTONADIONE tablets, for oral use Initial U.S. Approval: 1955
69238-1051-3	2024-04-26	These highlights do not include all the information needed to use PHYTONADIONE TABLETS safely and effectively. See full prescribing information for PHYTONADIONE TABLETS. PHYTONADIONE tablets, for oral use Initial U.S. Approval: 1955
69238-1051-1	2024-01-30	These highlights do not include all the information needed to use PHYTONADIONE TABLETS safely and effectively. See full prescribing information for PHYTONADIONE TABLETS. PHYTONADIONE tablets, for oral use Initial U.S. Approval: 1955
69238-1051-3	2024-01-30	These highlights do not include all the information needed to use PHYTONADIONE TABLETS safely and effectively. See full prescribing information for PHYTONADIONE TABLETS. PHYTONADIONE tablets, for oral use Initial U.S. Approval: 1955

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69238-1051-1	Phytonadione	100 in 1 BOTTLE	TABLET	100	6
69238-1051-1	Phytonadione	1 in 1 CARTON	TABLET	1	6
69238-1051-3	Phytonadione	1 in 1 CARTON	TABLET	1	6
69238-1051-3	Phytonadione	30 in 1 BOTTLE	TABLET	30	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69238-1051-1	EA - Each	69238-1051	4aa62a11-2098-4d66-905e-ac3703071e4a	1	2018-06-11
69238-1051-3	EA - Each	69238-1051	5aa4f599-ab95-4d4e-96a9-4fa48fb4a4dc	1	2019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69238-1051	PHYTONADIONE TABLET [AMNEAL PHARMACEUTICALS NY LLC]	6	Current NDC, Legacy NDC, 4 package rows	20241219_54c1c1df-0e65-4da8-9023-6cbaa0f5bd0d.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phytonadione	PHYTONADIONE	Major Pharmaceuticals	54f23bc8-d8f3-40e8-a93d-3121cc581d54	2026-03-16	Adverse reactions	Exact identifier application applno (ANDA): 209373 application number: ANDA209373
Phytonadione	PHYTONADIONE	Amneal Pharmaceuticals NY LLC	54c1c1df-0e65-4da8-9023-6cbaa0f5bd0d	2024-12-09	Adverse reactions	Exact identifier application applno (ANDA): 209373 application number: ANDA209373 ndc (product): 69238-1051
Phytonadione	PHYTONADIONE	American Health Packaging	88d13044-6ce8-4374-86ff-e8d9eea27829	2024-09-24	Adverse reactions	Exact identifier application applno (ANDA): 209373 application number: ANDA209373

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	54c1c1df-0e65-4da8-9023-6cbaa0f5bd0d	6
198102	phytonadione 5 MG Oral Tablet	PSN	54f23bc8-d8f3-40e8-a93d-3121cc581d54	6
198102	vitamin K1 5 MG Oral Tablet	SCD	54c1c1df-0e65-4da8-9023-6cbaa0f5bd0d	6
198102	vitamin K1 5 MG Oral Tablet	SCD	54f23bc8-d8f3-40e8-a93d-3121cc581d54	6
198102	phytonadione 5 MG Oral Tablet	SY	54c1c1df-0e65-4da8-9023-6cbaa0f5bd0d	6
198102	phytonadione 5 MG Oral Tablet	SY	54f23bc8-d8f3-40e8-a93d-3121cc581d54	6
198102	phytonadione 5 MG Oral Tablet	PSN	88d13044-6ce8-4374-86ff-e8d9eea27829	5
198102	vitamin K1 5 MG Oral Tablet	SCD	88d13044-6ce8-4374-86ff-e8d9eea27829	5
198102	phytonadione 5 MG Oral Tablet	SY	88d13044-6ce8-4374-86ff-e8d9eea27829	5
198102	phytonadione 5 MG Oral Tablet	PSN	04c776dd-b60d-23f6-e063-6394a90a247c	2
198102	vitamin K1 5 MG Oral Tablet	SCD	04c776dd-b60d-23f6-e063-6394a90a247c	2
198102	phytonadione 5 MG Oral Tablet	SY	04c776dd-b60d-23f6-e063-6394a90a247c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69238-1051-1	69238105101	1 BOTTLE in 1 CARTON (69238-1051-1) / 100 TABLET in 1 BOTTLE	1 bottle	2018-05-15	0000-00-00	No	No	Current
69238-1051-3	69238105103	1 BOTTLE in 1 CARTON (69238-1051-3) / 30 TABLET in 1 BOTTLE	1 bottle	2018-05-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phytonadione	Major Pharmaceuticals	2026-03-16	HUMAN PRESCRIPTION DRUG LABEL	6
Phytonadione	AvKARE	2026-01-15	HUMAN PRESCRIPTION DRUG LABEL	2
Phytonadione	Amneal Pharmaceuticals NY LLC \| Amneal Pharmaceuticals Private Limited	2024-12-09	HUMAN PRESCRIPTION DRUG LABEL	6
Phytonadione	American Health Packaging	2024-09-24	HUMAN PRESCRIPTION DRUG LABEL	5