Phytonadione

Product NDC: 42291-566
Requested package NDC: 42291-566-30
11-digit product format: 422910566
Labeler code: 42291
Product ID: 42291-566_487102e3-f317-836b-e063-6394a90a4438
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phytonadione
Dosage form: TABLET
Route: ORAL
Labeler: AvKARE
Application: ANDA209373
Marketing category: ANDA
Marketing start: 2023-09-07
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: 2027-12-31
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	42291-566	42291-566-30	D	Discontinued by firm		2026-08-17

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…`

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42291-566-30	Phytonadione	1 in 1 BOX	TABLET	1		2
42291-566-30	Phytonadione	30 in 1 BOTTLE	TABLET	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-566-30	EA - Each	42291-566	bbf8c6b5-7cb2-4a12-830e-f2d4687b29e9	1	2023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-566	PHYTONADIONE TABLET [AVKARE]	1	Current NDC, 2 package rows	20230908_04c776dd-b60d-23f6-e063-6394a90a247c.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
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	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	Sample	Exclude flag	Status
42291-566-30	42291056630	1 BOTTLE in 1 BOX (42291-566-30) / 30 TABLET in 1 BOTTLE	1 bottle	2023-09-07	No	No	Historical