Humalog

Product NDC: 0002-7512
11-digit product format: 000027512
Labeler code: 0002
Product ID: 0002-7512_b2e34993-838d-4e33-bf5e-c9fa4920a536
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Insulin lispro
Dosage form: INJECTION, SUSPENSION
Route: SUBCUTANEOUS
Labeler: Eli Lilly and Company
Application: BLA021018
Marketing category: BLA
Marketing start: 1999-12-22
Marketing end: 0000-00-00
Substance: INSULIN LISPRO
Active strength: 100 [iU]/mL
Pharmacologic classes: Insulin Analog [EPC], Insulin [Chemical/Ingredient]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0002-7512		D	Discontinued by firm	2026-08-11
excluded package	package	0002-7512	0002-7512-01	D	Discontinued by firm	2026-08-11
excluded package	package	0002-7512	0002-7512-99	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 · 36 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	0002-7512-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0002-7512-99	`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	0002-7512-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0002-7512-99	`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	0002-7512-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0002-7512-99	`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	0002-7512-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0002-7512-99	`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	0002-7512-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0002-7512-99	`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	0002-7512-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0002-7512-99	`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	0002-7512-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0002-7512-99	`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	0002-7512-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0002-7512-99	`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	0002-7512-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0002-7512-99	`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	0002-7512-99	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0002-7512-01	`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	0002-7512-99	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0002-7512-01	`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	0002-7512-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0002-7512-99	`557ba5c1ecfa…`	`9c80585c8c6e…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a42609d2-d76b-4c21-bc65-ace5fa0da69d	Product name	1	20210105
0c5ba5d1-c81f-5bcc-49a8-b8e264edfb14	Product name	3	20200325
4477e8cc-8057-4880-8829-dfea528a2efa	Product name	2	20200325

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0002-7512-01	Humalog Mix50/50	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SUSPENSION	10	54
0002-7512-01	Humalog Mix50/50	1 in 1 CARTON	INJECTION, SUSPENSION	1	54
0002-7512-99	Humalog Mix50/50	1 in 1 CARTON	INJECTION, SUSPENSION	1	54
0002-7512-99	Humalog Mix50/50	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SUSPENSION	10	54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0002-7512-01	ML - Milliliter	0002-7512	de85e37d-ca0d-4ba8-8577-37dd18bea033	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Insulin lispro	ACTIVE INGREDIENT	GFX7QIS1II	HUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]	32
Insulin lispro	ACTIVE MOIETY	GFX7QIS1II	HUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]	32
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	HUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]	32
Hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	HUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]	32
Metacresol	INACTIVE INGREDIENT	GGO4Y809LO	HUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]	32
Phenol	INACTIVE INGREDIENT	339NCG44TV	HUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]	32
Protamine sulfate	INACTIVE INGREDIENT	0DE9724IHC	HUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]	32
Sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	HUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]	32
Sodium Phosphate, Dibasic	INACTIVE INGREDIENT	GR686LBA74	HUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]	32
Water	INACTIVE INGREDIENT	059QF0KO0R	HUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]	32
Zinc	INACTIVE INGREDIENT	J41CSQ7QDS	HUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]	32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0002-7512	HUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]	53	Legacy NDC, 4 package rows	20241215_b34cd3ff-d0af-4852-b4ef-2a8b4a93aeae.zip

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
Humalog Mix50/50 KwikPen	INSULIN LISPRO	Eli Lilly and Company	b34cd3ff-d0af-4852-b4ef-2a8b4a93aeae	2026-01-13	Warnings, Adverse reactions	Exact identifier application number: BLA021018 ndc (product): 0002-7512

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
021018	Humalog Mix 50/50	insulin lispro protamine and insulin lispro	351(a)	Disc	2026-07-01

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
847213	HumaLOG Mix 50/50 in 3 ML Pen Injector	PSN	b34cd3ff-d0af-4852-b4ef-2a8b4a93aeae	54
731281	HumaLOG Mix 50/50 Injectable Suspension	PSN	b34cd3ff-d0af-4852-b4ef-2a8b4a93aeae	54
847211	insulin lispro protamine / insulin lispro 50/50 in 3 ML Pen Injector	PSN	b34cd3ff-d0af-4852-b4ef-2a8b4a93aeae	54
260265	insulin lispro protamine / insulin lispro 50/50 Injectable Suspension	PSN	b34cd3ff-d0af-4852-b4ef-2a8b4a93aeae	54
847213	3 ML insulin lispro 50 UNT/ML / insulin lispro protamine, human 50 UNT/ML Pen Injector [Humalog Mix]	SBD	b34cd3ff-d0af-4852-b4ef-2a8b4a93aeae	54
731281	insulin lispro 50 UNT/ML / insulin lispro protamine, human 50 UNT/ML Injectable Suspension [Humalog Mix]	SBD	b34cd3ff-d0af-4852-b4ef-2a8b4a93aeae	54
847211	3 ML insulin lispro 50 UNT/ML / insulin lispro protamine, human 50 UNT/ML Pen Injector	SCD	b34cd3ff-d0af-4852-b4ef-2a8b4a93aeae	54
260265	insulin lispro 50 UNT/ML / insulin lispro protamine, human 50 UNT/ML Injectable Suspension	SCD	b34cd3ff-d0af-4852-b4ef-2a8b4a93aeae	54
731281	Humalog Mix 50/50 100 UNT/ML Injectable Suspension	SY	b34cd3ff-d0af-4852-b4ef-2a8b4a93aeae	54
847213	Humalog Mix 50/50 300 UNT per 3 ML KwikPen	SY	b34cd3ff-d0af-4852-b4ef-2a8b4a93aeae	54
847213	Humalog Mix 50/50 300 UNT per 3 ML Prefilled Pen	SY	b34cd3ff-d0af-4852-b4ef-2a8b4a93aeae	54
260265	insulin analog, lispro mixed 50/50 100 UNT/ML Injectable Suspension	SY	b34cd3ff-d0af-4852-b4ef-2a8b4a93aeae	54
847211	insulin lispro protamine 150 UNT / insulin lispro 150 UNT per 3 ML Pen Injector	SY	b34cd3ff-d0af-4852-b4ef-2a8b4a93aeae	54

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0002-7512-01	00002751201	1 VIAL, MULTI-DOSE in 1 CARTON (0002-7512-01) > 10 mL in 1 VIAL, MULTI-DOSE	2006-02-07	0000-00-00	No	No	Current
0002-7512-99	00002751299	1 VIAL, MULTI-DOSE in 1 CARTON (0002-7512-99) > 10 mL in 1 VIAL, MULTI-DOSE	2006-10-19	0000-00-00	Yes	No	Current