Humulin 70/30 Purple Book BLA 019717

BLA number: 019717
Proprietary names: Humulin 70/30
Proper names: insulin isophane human and insulin human
Applicant: Eli Lilly and Company
Center: CDER
First observed release: 2020-05-01
Latest observed release: 2026-06-01
Newest archive release: 2026-06-01
FDA patent list: No patents listed in the captured FDA patent list; source updated 2025-06-11
Coverage: Present in newest release

Latest Known Product Presentations#

Product, Proprietary name, Proper name table
Product	Proprietary name	Proper name	License type	Strength	Dosage form	Route	Presentation	Marketing	Licensure	Approval	Patent list provided
001	Humulin 70/30	insulin isophane human and insulin human	351(a)	700UNITS/10ML (70UNITS/ML); 300UNITS/10ML (30UNITS/ML)	Injectable Suspension	Subcutaneous	Multi-Dose Vial	OTC	Licensed	1989-04-25
002	Humulin 70/30	insulin isophane human and insulin human	351(a)	210UNITS/3ML (70UNITS/ML); 90UNITS/3ML (30UNITS/ML)	Injectable Suspension	Subcutaneous	Multi-Dose Vial	OTC	Licensed	1989-04-25
003	Humulin 70/30	insulin isophane human and insulin human	351(a)	210UNITS/3ML (70UNITS/ML); 90UNITS/3ML (30UNITS/ML)	Injectable Suspension	Subcutaneous	Autoinjector	OTC	Licensed	2013-11-07

Published Patent List#

No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.

NDC, Proprietary name, Nonproprietary name table
NDC	Proprietary name	Nonproprietary name	Labeler	Source
0002-8715	Humulin	Insulin human	Eli Lilly and Company	current
0002-8803	Humulin	Insulin human	Eli Lilly and Company	current

Label, Manufacturer, Effective table
Label	Manufacturer	Effective
Humulin 70/30	Eli Lilly and Company	2024-12-10
Humulin 70/30	A-S Medication Solutions	2017-10-12
Humalog 70/30 - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2010-11-05

Official Monthly Change Events#

Release, Event, Product table
Release	Event	Product	Name	License type	Status	Applicant
2021-07-01	U	003	Humulin 70/30	351(a)	OTC	Eli Lilly and Company
2020-05-01	R	001	Humulin 70/30	351(a)	OTC	Eli Lilly and Company
2020-05-01	R	002	Humulin 70/30	351(a)	OTC	Eli Lilly and Company
2020-05-01	R	003	Humulin 70/30	351(a)	OTC	Eli Lilly and Company

Observed Product State History#

Release, Product, Name table
Release	Product	Name	License type	Marketing	Licensure	Approval
2020-05-01	001	Humulin 70/30	351(a)	OTC	Licensed	1989-04-25
2020-05-01	002	Humulin 70/30	351(a)	OTC	Licensed	1989-04-25
2020-05-01	003	Humulin 70/30	351(a)	OTC	Licensed	2013-11-07