PHYTONADIONE

Product NDC: 51662-1698
11-digit product format: 516621698
Labeler code: 51662
Product ID: 51662-1698_596cedea-ae71-a84f-e063-6394a90a54df
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PHYTONADIONE
Dosage form: INJECTION, EMULSION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: HF Acquisition Co LLC, DBA HealthFirst
Application: ANDA207719
Marketing category: ANDA
Marketing start: 2019-05-31
Substance: PHYTONADIONE
Active strength: 10 mg/mL
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
A207719-001	PHYTONADIONE	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB1		2019-05-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207719-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB1	2019-05-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB1	2019-05-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB1	2019-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB1	2019-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB1	2019-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB1	2019-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB1	2019-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB1	2019-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB1	2019-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB1	2019-05-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB1	2019-05-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB1	2019-05-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB1	2019-05-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB1	2019-05-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB1	2019-05-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB1	2019-05-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB1	2019-05-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB	2019-05-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB	2019-05-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB	2019-05-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB	2019-05-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB	2019-05-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB	2019-05-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB	2019-05-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB	2019-05-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB	2019-05-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB	2019-05-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB	2019-05-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB	2019-05-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB1	2019-05-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB1	2019-05-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB1	2019-05-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB1	2019-05-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB1	2019-05-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB1	2019-05-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB1	2019-05-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB1	2019-05-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB1	2019-05-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB1	2019-05-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207719-001	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB1	2019-05-22	`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	A207719-001	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207719-001	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207719-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207719-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207719-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207719-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207719-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207719-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207719-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207719-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207719-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207719-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207719-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207719-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207719-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207719-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207719-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207719-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207719-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207719-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207719-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207719-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207719-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207719-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207719-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207719-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207719-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207719-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207719-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207719-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207719-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207719-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207719-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207719-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207719-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207719-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207719-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207719-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207719-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207719-001	AB1	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	10 mg/mL

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
1670192	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
5686f34b-446a-00ae-e063-6394a90a6029	Available on FDA.report

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	HF Acquisition Co LLC, DBA HealthFirst	5686f34b-446a-00ae-e063-6394a90a6029	2026-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207719 application number: ANDA207719 ndc (product): 51662-1698
PHYTONADIONE	PHYTONADIONE	Henry Schein, Inc.	1cf90be3-a744-4db5-999d-a84c67372304	2025-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207719 application number: ANDA207719
PHYTONADIONE PHYTONADIONE	PHYTONADIONE	Dr.Reddy's Laboratories Inc	02445c07-7b4b-cd70-54e8-ebefc814f547	2019-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207719 application number: ANDA207719

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
51662-1698-3	51662169803	25 POUCH in 1 CASE (51662-1698-3) / 1 AMPULE in 1 POUCH (51662-1698-2) / 1 mL in 1 AMPULE	25 pouch	2019-05-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PHYTONADIONE - HF Acquisition Co LLC, DBA HealthFirst	HF Acquisition Co LLC, DBA HealthFirst	2026-08-19	HUMAN PRESCRIPTION DRUG LABEL	2