Novolin

Product NDC: 68071-1701
Requested package NDC: 68071-1701-1
11-digit product format: 680711701
Labeler code: 68071
Product ID: 68071-1701_bb12818d-d70a-b501-e053-2a95a90a7c61
Type: HUMAN OTC DRUG
Nonproprietary name: Human Insulin
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: NuCare Pharmaceuticals,Inc.
Application: BLA019938
Marketing category: BLA
Marketing start: 1991-06-25
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	68071-1701	68071-1701-1	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 · 15 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-1701-1	2024-07-15	C162847	48780-1	ba0f9c33-4033-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use NOVOLIN R safely and effectively. See full prescribing information for NOVOLIN R. NOVOLIN ® R (insulin human injection), for subcutaneous or intravenous use Initial U.S. Approval: 1991
68071-1701-1	2023-01-30	C162847	48780-1	ba0f9c33-4033-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use NOVOLIN R safely and effectively. See full prescribing information for NOVOLIN R. NOVOLIN ® R (insulin human injection), for subcutaneous or intravenous use Initial U.S. Approval: 1991
68071-1701-1	2021-02-11	C162847	48780-1	ba0f9c33-4033-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use NOVOLIN R safely and effectively. See full prescribing information for NOVOLIN R. NOVOLIN ® R (insulin human injection), for subcutaneous or intravenous use Initial U.S. Approval: 1991

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
Novolin R	HUMAN INSULIN	Novo Nordisk	aee7f1f3-612c-4027-8ce9-4fd1f41eed71	2022-11-23	Warnings, Adverse reactions	Exact identifier application number: BLA019938

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
019938	Novolin R	insulin human	351(a)	OTC	2026-07-01

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
68071-1701-1	68071170101	10 mL in 1 BOX (68071-1701-1)	10 ml	2019-02-07	0000-00-00	No	No	Current