Home NDC 69097-003 Phytonadione
Product NDC 69097-003
11-digit product format 690970003
Labeler code 69097
Product ID 69097-003_d0d625e2-d304-4382-bd6a-e714de668f13
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phytonadione
Dosage form INJECTION, EMULSION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Cipla USA Inc.
Application ANDA214966
Marketing category ANDA
Marketing start 2025-01-15
Substance PHYTONADIONE
Active strength 1 mg/.5mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214966-001 PHYTONADIONE PHYTONADIONE 1MG/0.5ML INJECTABLE / INJECTION AB1 2025-01-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214966-001 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.
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 A214966-001 PHYTONADIONE 1MG/0.5ML INJECTABLE / INJECTION AB1 2025-01-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214966-001 PHYTONADIONE 1MG/0.5ML INJECTABLE / INJECTION AB 2025-01-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214966-001 PHYTONADIONE 1MG/0.5ML INJECTABLE / INJECTION AB 2025-01-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214966-001 PHYTONADIONE 1MG/0.5ML INJECTABLE / INJECTION AB 2025-01-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214966-001 PHYTONADIONE 1MG/0.5ML INJECTABLE / INJECTION AB 2025-01-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214966-001 PHYTONADIONE 1MG/0.5ML INJECTABLE / INJECTION AB 2025-01-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214966-001 PHYTONADIONE 1MG/0.5ML INJECTABLE / INJECTION AB 2025-01-03 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214966-001 PHYTONADIONE 1MG/0.5ML INJECTABLE / INJECTION AB1 2025-01-03 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214966-001 CGT 2025-09-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214966-001 CGT 2025-09-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214966-001 CGT 2025-09-06 fd3edfee7708…
Additional Listing Data#
Finished product Yes
Brand name base Phytonadione
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHYTONADIONE 1 mg/.5mL
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 727625 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69097-003-67 Phytonadione 0.5 mL in 1 SYRINGE INJECTION, EMULSION 0.5 2 69097-003-96 Phytonadione 10 in 1 CARTON INJECTION, EMULSION 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69097-003 PHYTONADIONE INJECTION, EMULSION [CIPLA USA INC.] 2 Current NDC, 2 package rows 20250115_4bc2de7b-6564-4d77-8a65-6be57b706093.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69097-003-67 69097000367 0.5 mL in 1 SYRINGE 0.5 ml Historical 69097-003-96 69097000396 10 SYRINGE in 1 CARTON (69097-003-96) / .5 mL in 1 SYRINGE (69097-003-67) 10 syringe 2025-01-15 No No Current