INTRON A

Product NDC
0085-4351
11-digit product format
000854351
Labeler code
0085
Product ID
0085-4351_1353cc19-005b-4bb0-ba0c-eeacedeb1ca1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
interferon alfa-2b
Dosage form
KIT
Labeler
Merck Sharp & Dohme LLC
Application
BLA103132
Marketing category
BLA
Marketing start
2014-08-11
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0085-4351DDiscontinued by firm2026-08-10
excluded packagepackage0085-43510085-4351-01DDiscontinued by firm2026-08-10

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0085-4351-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0085-4351-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0085-4351-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0085-4351-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0085-4351-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0085-4351-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0085-4351-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0085-4351-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0085-4351-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0085-4351-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0085-4351-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0085-4351-01557ba5c1ecfa…9c80585c8c6e…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0085-4351-01EA - Each0085-4351890db838-0c23-4ef4-8a3b-a3eae6d9710812014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
interferon alfa-2bACTIVE INGREDIENT43K1W2T1M6INTRON A (INTERFERON ALFA-2B) KIT INTRON A (INTERFERON ALFA-2B) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.]3
Interferon alfa-2bACTIVE MOIETY43K1W2T1M6INTRON A (INTERFERON ALFA-2B) KIT INTRON A (INTERFERON ALFA-2B) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.]3
Albumin (Human)INACTIVE INGREDIENTZIF514RVZRINTRON A (INTERFERON ALFA-2B) KIT INTRON A (INTERFERON ALFA-2B) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.]3
edetate disodiumINACTIVE INGREDIENT7FLD91C86KINTRON A (INTERFERON ALFA-2B) KIT INTRON A (INTERFERON ALFA-2B) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.]3
GlycineINACTIVE INGREDIENTTE7660XO1CINTRON A (INTERFERON ALFA-2B) KIT INTRON A (INTERFERON ALFA-2B) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.]3
metacresolINACTIVE INGREDIENTGGO4Y809LOINTRON A (INTERFERON ALFA-2B) KIT INTRON A (INTERFERON ALFA-2B) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.]3
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HINTRON A (INTERFERON ALFA-2B) KIT INTRON A (INTERFERON ALFA-2B) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.]3
sodium chlorideINACTIVE INGREDIENT451W47IQ8XINTRON A (INTERFERON ALFA-2B) KIT INTRON A (INTERFERON ALFA-2B) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.]3
Sodium Phosphate, DibasicINACTIVE INGREDIENTGR686LBA74INTRON A (INTERFERON ALFA-2B) KIT INTRON A (INTERFERON ALFA-2B) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.]3
Sodium Phosphate, MonobasicINACTIVE INGREDIENT3980JIH2SWINTRON A (INTERFERON ALFA-2B) KIT INTRON A (INTERFERON ALFA-2B) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.]3

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103132Intron Ainterferon alfa-2b351(a)Disc2026-06-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0085-4351-01000854351011 KIT in 1 CARTON (0085-4351-01) * 1.25 mL in 1 VIAL * 5 mL in 1 VIAL (0085-4346-01) 1 kit2014-08-110000-00-00NoNoCurrent