Phytonadione

Product NDC: 69097-708
11-digit product format: 690970708
Labeler code: 69097
Product ID: 69097-708_b3dd9cac-1295-48b6-b9b1-48d36cb732b9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phytonadione
Dosage form: INJECTION, EMULSION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: Cipla USA Inc.
Application: ANDA214596
Marketing category: ANDA
Marketing start: 2022-04-27
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A214596-001	PHYTONADIONE	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	AB2	RS	2022-04-22
A214596-002	PHYTONADIONE	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214596-001	AB2

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 · 60 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
2026-08-18 06:07:40	2026-07	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	AB2	RS	2022-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	AB2		2022-04-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB2		2022-04-22	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A214596-001	AB2	1	`caaa826d4ba7…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214596-001	AB2	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214596-002	AB2	1	`5c6f7cd8ea54…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214596-001	AB2	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214596-002	AB2	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214596-001	AB2	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214596-001	CGT	2022-10-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214596-002	CGT	2022-10-30	`5c6f7cd8ea54…`
2023-01-26 05:58 UTC	2023-01	A214596-001	CGT	2022-10-30	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A214596-002	CGT	2022-10-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214596-001	CGT	2022-10-30	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214596-002	CGT	2022-10-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214596-001	CGT	2022-10-30	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A214596-002	CGT	2022-10-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214596-001	CGT	2022-10-30	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A214596-002	CGT	2022-10-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214596-001	CGT	2022-10-30	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214596-002	CGT	2022-10-30	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Phytonadione
Listing expiration: 2026-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312424	Internal RxNorm lookup
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
1add4de5-0f9c-453e-9dd5-abb8077b566a	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
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
081b54f0-4545-48b6-b854-03e1401f09ea	Product name	1	20230112
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
aead65a2-216e-4ff8-a178-44aab77c24ed	Product name	1	20180531
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69097-708-96	Phytonadione	1 mL in 1 VIAL	INJECTION, EMULSION	1		5
69097-708-96	Phytonadione	10 in 1 CARTON	INJECTION, EMULSION	10		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69097-708-96	ML - Milliliter	69097-708	e215400f-6f39-41bf-9404-4ac348edf55c	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69097-708	PHYTONADIONE INJECTION, EMULSION [CIPLA USA INC.]	5	Current NDC, Legacy NDC, 2 package rows	20240713_1add4de5-0f9c-453e-9dd5-abb8077b566a.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phytonadione	PHYTONADIONE	Cipla USA Inc.	1add4de5-0f9c-453e-9dd5-abb8077b566a	2024-07-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214596 application number: ANDA214596 ndc (product): 69097-708

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
312424	phytonadione 1 MG in 0.5 ML Injection	PSN	1add4de5-0f9c-453e-9dd5-abb8077b566a	5
1670192	phytonadione 10 MG in 1 ML Injection	PSN	1add4de5-0f9c-453e-9dd5-abb8077b566a	5
312424	0.5 ML vitamin K1 2 MG/ML Injection	SCD	1add4de5-0f9c-453e-9dd5-abb8077b566a	5
1670192	1 ML vitamin K1 10 MG/ML Injection	SCD	1add4de5-0f9c-453e-9dd5-abb8077b566a	5
312424	phytonadione 1 MG per 0.5 ML Injection	SY	1add4de5-0f9c-453e-9dd5-abb8077b566a	5
1670192	phytonadione 10 MG per 1 ML Injection	SY	1add4de5-0f9c-453e-9dd5-abb8077b566a	5
1670192	vitamin K 1 10 MG per 1 ML Injection	SY	1add4de5-0f9c-453e-9dd5-abb8077b566a	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69097-708-96	69097070896	10 VIAL in 1 CARTON (69097-708-96) / 1 mL in 1 VIAL	10 vial	2022-04-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phytonadione - Cipla USA Inc. \| Cipla Limited \| Immacule Lifesciences Private Limited	Cipla USA Inc. \| Cipla Limited \| Immacule Lifesciences Private Limited	2024-07-12	HUMAN PRESCRIPTION DRUG LABEL	5