Phytonadione Tablets, USP

Manufacturer: Zydus Lifesciences Limited
Effective date: 2022-11-01
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-05-31 20:44:49

Label at a glance#

ProductPhytonadione

Active ingredientPHYTONADIONE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Phytonadione Tablets USP, 5 mg

100 tablets

NDC 70771-1318-1

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198102	phytonadione 5 MG Oral Tablet	PSN	6
198102	vitamin K1 5 MG Oral Tablet	SCD	6
198102	phytonadione 5 MG Oral Tablet	SY	6

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
PHYTONADIONE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

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
70771-1318-1	Phytonadione	1 in 1 CARTON	TABLET	1	6
70771-1318-1	Phytonadione	100 in 1 BOTTLE	TABLET	100	6
70771-1318-2	Phytonadione	10 in 1 BLISTER PACK	TABLET	10	6
70771-1318-3	Phytonadione	30 in 1 BOTTLE	TABLET	30	6
70771-1318-4	Phytonadione	10 in 1 CARTON	TABLET	10	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1318	PHYTONADIONE TABLET [ZYDUS LIFESCIENCES LIMITED]	6	Current NDC, Legacy NDC, 5 package rows	20221107_fa26f747-c64e-4090-a0cf-de3d3d9b004c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

Phytonadione
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE (110000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SILICON DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1318	70771-1318-1, 70771-1318-2, 70771-1318-4, 70771-1318-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PHYTONADIONE	A034SE7857	ACTIB
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)	5Y0974F5PW	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phytonadione	PHYTONADIONE	Zydus Lifesciences Limited	fa26f747-c64e-4090-a0cf-de3d3d9b004c	2022-11-01		Exact identifier ndc (package): 70771-1318-4 ndc (package): 70771-1318-2 ndc (package): 70771-1318-1 ndc (package): 70771-1318-3 ndc (product): 70771-1318 ndc11 (package): 70771131803 ndc11 (package): 70771131801 ndc11 (package): 70771131804 ndc11 (package): 70771131802 spl id: 40070531-4723-48f2-89b4-9efde4d1c71f spl set id: fa26f747-c64e-4090-a0cf-de3d3d9b004c

Reported adverse events (FAERS/openFDA)#

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