FDA.reportPublic FDA data

EXTAVIA

Product NDC
0078-0569
Requested package NDC
0078-0569-12
11-digit product format
000780569
Labeler code
0078
Product ID
0078-0569_4e7c467e-e094-4687-9c49-87d4f4de61df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Interferon beta-1b
Dosage form
KIT
Labeler
Novartis Pharmaceuticals Corporation
Application
BLA125290
Marketing category
BLA
Marketing start
2009-08-14
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2023-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0078-05690078-0569-12DDiscontinued by firm2026-08-03

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0078-0569-122023-08-01C16284748780-10191ceaa-6972-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use EXTAVIA safely and effectively. See full prescribing information for EXTAVIA. EXTAVIA ® (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993
0078-0569-122023-07-28C16284748780-10191ceaa-6972-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use EXTAVIA safely and effectively. See full prescribing information for EXTAVIA. EXTAVIA ® (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0569-12EA - Each0078-05699ed9ad4c-8ea1-4feb-8c0a-c54bea28808412012-07-24
0078-0569-61EA - Each0078-0569a7e19574-f491-42ff-81fd-b7a43b8322e612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INTERFERON BETA-1BACTIVE INGREDIENTTTD90R31WZEXTAVIA (INTERFERON BETA-1B) KIT [NOVARTIS PHARMACEUTICALS CORPORATION]11
INTERFERON BETA-1BACTIVE MOIETYTTD90R31WZEXTAVIA (INTERFERON BETA-1B) KIT [NOVARTIS PHARMACEUTICALS CORPORATION]11
ALBUMIN (HUMAN)INACTIVE INGREDIENTZIF514RVZREXTAVIA (INTERFERON BETA-1B) KIT [NOVARTIS PHARMACEUTICALS CORPORATION]11
MANNITOLINACTIVE INGREDIENT3OWL53L36AEXTAVIA (INTERFERON BETA-1B) KIT [NOVARTIS PHARMACEUTICALS CORPORATION]11
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XEXTAVIA (INTERFERON BETA-1B) KIT [NOVARTIS PHARMACEUTICALS CORPORATION]11

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125290Extaviainterferon beta-1b351(a)Disc2026-06-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0569-120007805691215 BLISTER PACK in 1 CARTON (0078-0569-12) > 1 KIT in 1 BLISTER PACK (0078-0569-61) * 3 mL in 1 VIAL, SINGLE-USE * 1.2 mL in 1 SYRINGE15 blister pack2009-08-140000-00-00NoNoCurrent