Novolin

Product NDC: 50090-0498
Requested package NDC: 50090-0498-0
11-digit product format: 500900498
Labeler code: 50090
Product ID: 50090-0498_247ca1c3-2541-4653-917c-01941fe11af9
Type: HUMAN OTC DRUG
Nonproprietary name: Human Insulin
Dosage form: INJECTION, SUSPENSION
Route: SUBCUTANEOUS
Labeler: A-S Medication Solutions
Application: BLA019959
Marketing category: BLA
Marketing start: 1991-07-01
Marketing end: 0000-00-00
Substance: INSULIN HUMAN
Active strength: 100 [iU]/mL
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 package	package	50090-0498	50090-0498-0	D	Discontinued by firm		2026-11-06

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 · 9 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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-0498-0	2023-02-07	C162847	48780-1	f386c64a-2d4f-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use NOVOLIN N safely and effectively. See full prescribing information for NOVOLIN N. NOVOLIN ® N (insulin isophane human) injectable suspension, for subcutaneous use Initial U.S. Approval: 1991
50090-0498-0	2023-01-30	C162847	48780-1	f386c64a-2d4f-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use NOVOLIN N safely and effectively. See full prescribing information for NOVOLIN N. NOVOLIN ® N (insulin isophane human) injectable suspension, for subcutaneous use Initial U.S. Approval: 1991

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-0498-0	ML - Milliliter	50090-0498	be53b882-a8d1-44b1-b237-6c52832d5bca	1	2018-09-05

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
019959	Novolin N	insulin isophane human	351(a)	OTC	2026-10-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1Y17CTI5SR	INSULIN HUMAN	11061-68-0	INSULIN HUMAN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-0498-0	50090049800	1 VIAL in 1 CARTON (50090-0498-0) > 10 mL in 1 VIAL	1 vial	2014-11-28	0000-00-00	No	No	Current