Phytonadione

Product NDC: 48433-160
11-digit product format: 484330160
Labeler code: 48433
Product ID: 48433-160_5b25d1a6-2150-e44e-e063-6394a90a8892
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phytonadione
Dosage form: TABLET
Route: ORAL
Labeler: Safecor Health, LLC
Application: ANDA210189
Marketing category: ANDA
Marketing start: 2026-09-02
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 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
2026-09-14 22:38:34	2026-08	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	RS	2019-02-20	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A210189-001	AB	1	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Phytonadione
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHYTONADIONE	5 mg/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 · 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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
48433-160-03	48433016003	30 BLISTER PACK in 1 CARTON (48433-160-03) / 1 TABLET in 1 BLISTER PACK (48433-160-01)	30 blister pack	2026-09-02	Yes	No	Current