PEGINTRON

Product NDC: 0085-1297
11-digit product format: 000851297
Labeler code: 0085
Product ID: 0085-1297_519a40d2-566f-4d64-8ffb-35813db6c6ae
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Peginterferon alfa-2b
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: SUBCUTANEOUS
Labeler: Merck Sharp & Dohme Corp.
Application: BLA103949
Marketing category: BLA
Marketing start: 2001-01-19
Marketing end: 0000-00-00
Substance: PEGINTERFERON ALFA-2B
Active strength: 120 ug/.5mL
Pharmacologic classes: Interferon-alpha [CS],Interferon alpha [EPC],Interferon-alpha [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0085-1297		D	Discontinued by firm	2026-08-10
excluded product	product	0085-1297		D	Discontinued by firm	2026-08-10
excluded package	package	0085-1297	0085-1297-01	D	Discontinued by firm	2026-08-10
excluded package	package	0085-1297	0085-1297-02	D	Discontinued by firm	2026-08-10
excluded package	package	0085-1297	0085-1297-03	D	Discontinued by firm	2026-08-10
excluded package	package	0085-1297	0085-1297-01	D	Discontinued by firm	2026-08-10
excluded package	package	0085-1297	0085-1297-02	D	Discontinued by firm	2026-08-10
excluded package	package	0085-1297	0085-1297-03	D	Discontinued by firm	2026-08-10

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 2 · 96 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0085-1297-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0085-1297-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0085-1297-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0085-1297-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0085-1297-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0085-1297-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0085-1297-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0085-1297-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0085-1297-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0085-1297-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0085-1297-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0085-1297-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0085-1297-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0085-1297-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0085-1297-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0085-1297-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0085-1297-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0085-1297-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0085-1297-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0085-1297-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0085-1297-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0085-1297-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0085-1297-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0085-1297-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0085-1297-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0085-1297-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0085-1297-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0085-1297-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0085-1297-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0085-1297-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0085-1297-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0085-1297-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0085-1297-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0085-1297-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0085-1297-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0085-1297-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0085-1297-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0085-1297-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0085-1297-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0085-1297-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0085-1297-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0085-1297-02	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0085-1297-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0085-1297-02	`ed331223b511…`	`672a5bd82f5f…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0085-1297-01	EA - Each	0085-1297	a781271e-8358-497d-a159-3bd31671d45a	1	2012-07-24
0085-1297-02	EA - Each	0085-1297	207c49ec-389e-4976-acb7-9e2ee7369c19	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Peginterferon alfa-2b	ACTIVE INGREDIENT	G8RGG88B68	PEGINTRON (PEGINTERFERON ALFA-2B) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PEGINTRON (PEGINTERFERON ALFA-2B) KIT [MERCK SHARP & DOHME CORP.]	5
interferon alfa-2b	ACTIVE MOIETY	43K1W2T1M6	PEGINTRON (PEGINTERFERON ALFA-2B) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PEGINTRON (PEGINTERFERON ALFA-2B) KIT [MERCK SHARP & DOHME CORP.]	5
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	PEGINTRON (PEGINTERFERON ALFA-2B) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PEGINTRON (PEGINTERFERON ALFA-2B) KIT [MERCK SHARP & DOHME CORP.]	5
sodium phosphate, dibasic, anhydrous	INACTIVE INGREDIENT	22ADO53M6F	PEGINTRON (PEGINTERFERON ALFA-2B) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PEGINTRON (PEGINTERFERON ALFA-2B) KIT [MERCK SHARP & DOHME CORP.]	5
sodium phosphate, monobasic, dihydrate	INACTIVE INGREDIENT	5QWK665956	PEGINTRON (PEGINTERFERON ALFA-2B) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PEGINTRON (PEGINTERFERON ALFA-2B) KIT [MERCK SHARP & DOHME CORP.]	5
sucrose	INACTIVE INGREDIENT	C151H8M554	PEGINTRON (PEGINTERFERON ALFA-2B) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PEGINTRON (PEGINTERFERON ALFA-2B) KIT [MERCK SHARP & DOHME CORP.]	5

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
103949	Pegintron	peginterferon alfa-2b	351(a)	Disc	2026-06-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G8RGG88B68	PEGINTERFERON ALFA-2B	215647-85-1	PEGINTERFERON ALFA-2B

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0085-1297-01	00085129701	1 CARTRIDGE in 1 CARTON (0085-1297-01) > .5 mL in 1 CARTRIDGE	1 cartridge	2001-01-19	0000-00-00	No	No	Current
0085-1297-02	00085129702	4 CARTRIDGE in 1 CARTON (0085-1297-02) > .5 mL in 1 CARTRIDGE	4 cartridge	2001-01-19	0000-00-00	No	No	Current
0085-1297-03	00085129703	1 CARTRIDGE in 1 CARTON (0085-1297-03) > .5 mL in 1 CARTRIDGE	1 cartridge	2001-01-19	0000-00-00	No	No	Current