OGIVRI

Product NDC: 67457-845
11-digit product format: 674570845
Labeler code: 67457
Product ID: 67457-845_476fea90-ea21-4542-80eb-e3cf13653ad9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: trastuzumab
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Mylan Institutional LLC
Application: BLA761074
Marketing category: BLA
Marketing start: 2019-11-29
Marketing end: 0000-00-00
Substance: TRASTUZUMAB
Active strength: 420 mg/20mL
Pharmacologic classes: HER2/neu Receptor Antagonist [EPC],HER2/Neu/cerbB2 Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	67457-845		D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
bd11614e-4776-4a92-aaca-2bcbb5f710ed	Product name	1	20210115
b914e981-d6dc-4748-bd51-accd6b85b817	Product name	1	20190618
9397f6d4-17a1-42b4-beda-fa2c0ea40c8c	Product name	1	20190610
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67457-845-20	2023-09-06	C162847	48780-1	f386c64a-3e12-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use OGIVRI safely and effectively. See full prescribing information for OGIVRI . OGIVRI ® (trastuzumab-dkst) for injection, for intravenous use Initial U.S. Approval: 2017 OGIVRI ® (trastuzumab-dkst) is biosimilar* to HERCEPTIN (trastuzumab).
67457-845-20	2023-02-01	C162847	48780-1	f386c64a-3e12-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use OGIVRI safely and effectively. See full prescribing information for OGIVRI . OGIVRI ® (trastuzumab-dkst) for injection, for intravenous use Initial U.S. Approval: 2017 OGIVRI ® (trastuzumab-dkst) is biosimilar* to HERCEPTIN (trastuzumab).

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67457-845-50	OGIVRI	20 mL in 1 VIAL, MULTI-DOSE	INJECTION, POWDER, LYOPHILIZED,	20 mL	420 mg in 20mL	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67457-845	OGIVRI (TRASTUZUMAB-DKST) KIT OGIVRI (TRASTUZUMAB-DKST) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC]	15	Legacy NDC	20240110_6b7938e6-14c7-4a65-9605-967542ecfb8f.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
OGIVRI	TRASTUZUMAB-DKST	Biocon Biologics Inc.	b6465b44-a6dd-f99c-d009-6851cf05169c	2024-11-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA761074

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761074	Ogivri	trastuzumab-dkst	351(k) Biosimilar	Rx	2026-07-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
P188ANX8CK	TRASTUZUMAB	180288-69-1	TRASTUZUMAB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2179758	OGIVRI 150 MG Injection	PSN	6b7938e6-14c7-4a65-9605-967542ecfb8f	15
2179763	OGIVRI 420 MG in 20 ML Injectable Solution	PSN	6b7938e6-14c7-4a65-9605-967542ecfb8f	15
2179753	trastuzumab-dkst 150 MG Injection	PSN	6b7938e6-14c7-4a65-9605-967542ecfb8f	15
2179760	trastuzumab-dkst 21 MG/ML Injectable Solution	PSN	6b7938e6-14c7-4a65-9605-967542ecfb8f	15
2179758	trastuzumab-dkst 150 MG Injection [Ogivri]	SBD	6b7938e6-14c7-4a65-9605-967542ecfb8f	15
2179763	trastuzumab-dkst 21 MG/ML Injectable Solution [Ogivri]	SBD	6b7938e6-14c7-4a65-9605-967542ecfb8f	15
2179753	trastuzumab-dkst 150 MG Injection	SCD	6b7938e6-14c7-4a65-9605-967542ecfb8f	15
2179760	trastuzumab-dkst 21 MG/ML Injectable Solution	SCD	6b7938e6-14c7-4a65-9605-967542ecfb8f	15
2179758	Ogivri 150 MG Injection	SY	6b7938e6-14c7-4a65-9605-967542ecfb8f	15
2179763	Ogivri 21 MG/ML Injectable Solution	SY	6b7938e6-14c7-4a65-9605-967542ecfb8f	15
2179763	Ogivri 420 MG per 20 ML Injectable Solution	SY	6b7938e6-14c7-4a65-9605-967542ecfb8f	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
67457-845-50	67457084550	20 mL in 1 VIAL, MULTI-DOSE	20 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OGIVRI - Mylan Institutional LLC	Mylan Institutional LLC	2021-02-08	HUMAN PRESCRIPTION DRUG LABEL	15