Insulin lispro

Product NDC: 66733-773
11-digit product format: 667330773
Labeler code: 66733
Product ID: 66733-773_19e48f5d-011c-427c-ad08-1ec22626361f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Insulin Lispro
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: ImClone LLC
Application: BLA020563
Marketing category: BLA
Marketing start: 2019-03-04
Marketing end: 0000-00-00
Substance: INSULIN LISPRO
Active strength: 100 [iU]/mL
Pharmacologic classes: Insulin [Chemical/Ingredient],Insulin Analog [EPC]
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	66733-773		D	Discontinued by firm		2026-08-11
excluded package	package	66733-773	66733-773-01	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 · 24 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 package	package	66733-773-01	`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 package	package	66733-773-01	`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 package	package	66733-773-01	`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 package	package	66733-773-01	`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 package	package	66733-773-01	`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 package	package	66733-773-01	`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 package	package	66733-773-01	`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 package	package	66733-773-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66733-773-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66733-773-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66733-773-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66733-773-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66733-773-01	ML - Milliliter	66733-773	7835d321-742a-47e9-9524-1b7acb682ea1	1	2019-04-11

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Humalog KwikPen	INSULIN LISPRO	Eli Lilly and Company	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	2026-01-09	Warnings, Adverse reactions	Exact identifier application number: BLA020563
Insulin Lispro	INSULIN LISPRO	Eli Lilly and Company	97d5e596-aae1-42c9-ae89-c3780959c467	2025-06-17	Warnings, Adverse reactions	Exact identifier application number: BLA020563
HUMALOG	INSULIN LISPRO	A-S Medication Solutions	c6b8ff07-d3e2-457f-8a38-b60de60adf75	2025-04-01	Warnings, Adverse reactions	Exact identifier application number: BLA020563
Insulin Lispro	INSULIN LISPRO	A-S Medication Solutions	2be14cbb-197a-4da8-82c8-2443594e7f6f	2024-05-31	Warnings, Adverse reactions	Exact identifier application number: BLA020563
HUMALOG	INSULIN LISPRO	A-S Medication Solutions	6ee01d2e-3525-4aa9-8ec1-5fb0f63dd47c	2024-02-15	Warnings, Adverse reactions	Exact identifier application number: BLA020563
Humalog KwikPen	INSULIN LISPRO	A-S Medication Solutions	51d3dc11-52b9-4296-a2f4-58c770d4448d	2024-01-24	Warnings, Adverse reactions	Exact identifier application number: BLA020563

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
020563	Humalog	insulin lispro	351(a)	Rx	2026-07-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
GFX7QIS1II	INSULIN LISPRO	133107-64-9	INSULIN LISPRO

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66733-773-01	66733077301	1 VIAL in 1 CARTON (66733-773-01) > 10 mL in 1 VIAL	1 vial	2019-03-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Insulin lispro	REMEDYREPACK INC.	2021-08-06	HUMAN PRESCRIPTION DRUG LABEL	3
Insulin lispro	ImClone LLC	2020-06-11	HUMAN PRESCRIPTION DRUG LABEL	4