Humalog

Product NDC: 0002-7516
11-digit product format: 000027516
Labeler code: 0002
Product ID: 0002-7516_d0a38a0f-9d29-44eb-bfd1-c83cbcba1008
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Insulin lispro
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: Eli Lilly and Company
Application: BLA020563
Marketing category: BLA
Marketing start: 1998-02-20
Substance: INSULIN LISPRO
Active strength: 100 [iU]/mL
Pharmacologic classes: Insulin Analog [EPC], Insulin [Chemical/Ingredient]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Humalog
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
INSULIN LISPRO	100 [iU]/mL

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	059QF0KO0R, GFX7QIS1II
Rxcui	242120, 865098, 1652239, 1652242, 1652639, 1652640, 1652644, 1652646, 1926331, 1926332, 2621571, 2621572

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75	Product name	2	20250814
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0002-7516-59	2024-01-30	C162847	48780-1	1030e365-4515-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use HUMALOG safely and effectively. See full prescribing information for HUMALOG. HUMALOG (insulin lispro) injection, for subcutaneous or intravenous use Initial U.S. Approval: 1996
0002-7516-99	2024-01-30	C162847	48780-1	1030e365-4515-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use HUMALOG safely and effectively. See full prescribing information for HUMALOG. HUMALOG (insulin lispro) injection, for subcutaneous or intravenous use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0002-7516-01	Humalog	3 mL in 1 CARTRIDGE	INJECTION, SOLUTION	3	86
0002-7516-59	Humalog	5 in 1 CARTON	INJECTION, SOLUTION	5	86
0002-7516-99	Humalog	3 mL in 1 CARTRIDGE	INJECTION, SOLUTION	3	86
0002-7516-99	Humalog	5 in 1 CARTON	INJECTION, SOLUTION	5	86

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0002-7516	HUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG JUNIOR KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG TEMPO PEN (INSULIN LISPRO) INJECTION, SOLUTION STERILE DILUENT (DILUENT) INJECTION, SOLUTION HUMALOG TEMPO PEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]	84	Current NDC, Legacy NDC, 4 package rows	20250523_c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f.zip

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
1652646	HumaLOG 100 UNT/ML in 3 ML Cartridge	PSN	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
1652640	HumaLOG 100 UNT/ML in 3 ML Pen Injector	PSN	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
865098	HumaLOG 100 UNT/ML Injectable Solution	PSN	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
1652242	HumaLOG 200 UNT/ML in 3 ML Pen Injector	PSN	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
1926332	HumaLOG Junior 100 UNT/ML in 3 ML Pen Injector	PSN	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
2621572	HumaLOG Tempo 100 UNT/ML in 3 ML Pen Injector	PSN	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
1652644	insulin lispro 100 UNT/ML in 3 ML Cartridge	PSN	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
1652639	insulin lispro 100 UNT/ML in 3 ML Pen Injector	PSN	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
2621571	insulin lispro 100 UNT/ML in 3 ML Pen Injector with Sensor	PSN	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
1926331	insulin lispro 100 UNT/ML in 3 ML Pen Injector, 0.5 UNT Doses	PSN	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
242120	insulin lispro 100 UNT/ML Injectable Solution	PSN	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
1652239	insulin lispro 200 UNT/ML in 3 ML Pen Injector	PSN	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
1926332	0.5 UNT Doses 3 ML insulin lispro 100 UNT/ML Pen Injector [Humalog]	SBD	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
1652646	3 ML insulin lispro 100 UNT/ML Cartridge [Humalog]	SBD	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
1652640	3 ML insulin lispro 100 UNT/ML Pen Injector [Humalog]	SBD	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
1652242	3 ML insulin lispro 200 UNT/ML Pen Injector [Humalog]	SBD	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
865098	insulin lispro 100 UNT/ML Injectable Solution [Humalog]	SBD	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
2621572	Sensor 3 ML insulin lispro 100 UNT/ML Pen Injector [Humalog]	SBD	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
1926331	0.5 UNT Doses 3 ML insulin lispro 100 UNT/ML Pen Injector	SCD	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
1652644	3 ML insulin lispro 100 UNT/ML Cartridge	SCD	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
1652639	3 ML insulin lispro 100 UNT/ML Pen Injector	SCD	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
1652239	3 ML insulin lispro 200 UNT/ML Pen Injector	SCD	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
242120	insulin lispro 100 UNT/ML Injectable Solution	SCD	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
2621571	Sensor 3 ML insulin lispro 100 UNT/ML Pen Injector	SCD	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
1926332	0.5 UNT Doses 3 ML Humalog 100 UNT/ML Pen Injector	SY	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
1652646	3 ML Humalog 100 UNT/ML Cartridge	SY	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
1652640	3 ML Humalog 100 UNT/ML Pen Injector	SY	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
1652242	3 ML Humalog 200 UNT/ML Pen Injector	SY	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
865098	Humalog 100 UNT/ML Injectable Solution	SY	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
1652646	Humalog 100 UNT/ML per 3 ML Cartridge	SY	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
2621572	Humalog 100 UNT/ML per 3 ML Pen Injector with Sensor	SY	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
2621572	Humalog 300 UNT per 3 ML Pen Injector with Sensor	SY	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
1652242	Humalog 600 UNT per 3 ML KwikPen	SY	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
1926332	Humalog Junior KwikPen 100 UNT/ML per 3 ML Pen Injector	SY	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
1652640	Humalog KwikPen 100 UNT/ML per 3 ML Pen Injector	SY	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
1652644	insulin lispro 100 UNT/ML per 3 ML Cartridge	SY	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
1652639	insulin lispro 100 UNT/ML per 3 ML Pen Injector	SY	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
2621571	insulin lispro 100 UNT/ML per 3 ML Pen Injector with Sensor	SY	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
1926331	insulin lispro 100 UNT/ML per 3 ML Pen Injector, 0.5 UNT Doses	SY	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
2621571	insulin lispro 300 UNT per 3 ML Pen Injector with Sensor	SY	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
242120	insulin, analog lispro 100 UNT/ML Injectable Solution	SY	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	86
1652646	HumaLOG 100 UNT/ML in 3 ML Cartridge	PSN	ce8354f4-bf07-4923-8755-47f3163662e4	3
1652640	HumaLOG 100 UNT/ML in 3 ML Pen Injector	PSN	ce8354f4-bf07-4923-8755-47f3163662e4	3
865098	HumaLOG 100 UNT/ML Injectable Solution	PSN	ce8354f4-bf07-4923-8755-47f3163662e4	3
1652644	insulin lispro 100 UNT/ML in 3 ML Cartridge	PSN	ce8354f4-bf07-4923-8755-47f3163662e4	3
1652639	insulin lispro 100 UNT/ML in 3 ML Pen Injector	PSN	ce8354f4-bf07-4923-8755-47f3163662e4	3
242120	insulin lispro 100 UNT/ML Injectable Solution	PSN	ce8354f4-bf07-4923-8755-47f3163662e4	3
1652646	3 ML insulin lispro 100 UNT/ML Cartridge [Humalog]	SBD	ce8354f4-bf07-4923-8755-47f3163662e4	3
1652640	3 ML insulin lispro 100 UNT/ML Pen Injector [Humalog]	SBD	ce8354f4-bf07-4923-8755-47f3163662e4	3
865098	insulin lispro 100 UNT/ML Injectable Solution [Humalog]	SBD	ce8354f4-bf07-4923-8755-47f3163662e4	3
1652644	3 ML insulin lispro 100 UNT/ML Cartridge	SCD	ce8354f4-bf07-4923-8755-47f3163662e4	3
1652639	3 ML insulin lispro 100 UNT/ML Pen Injector	SCD	ce8354f4-bf07-4923-8755-47f3163662e4	3
242120	insulin lispro 100 UNT/ML Injectable Solution	SCD	ce8354f4-bf07-4923-8755-47f3163662e4	3
1652646	3 ML Humalog 100 UNT/ML Cartridge	SY	ce8354f4-bf07-4923-8755-47f3163662e4	3
1652640	3 ML Humalog 100 UNT/ML Pen Injector	SY	ce8354f4-bf07-4923-8755-47f3163662e4	3
865098	Humalog 100 UNT/ML Injectable Solution	SY	ce8354f4-bf07-4923-8755-47f3163662e4	3
1652646	Humalog 100 UNT/ML per 3 ML Cartridge	SY	ce8354f4-bf07-4923-8755-47f3163662e4	3
1652640	Humalog KwikPen 100 UNT/ML per 3 ML Pen Injector	SY	ce8354f4-bf07-4923-8755-47f3163662e4	3
1652644	insulin lispro 100 UNT/ML per 3 ML Cartridge	SY	ce8354f4-bf07-4923-8755-47f3163662e4	3
1652639	insulin lispro 100 UNT/ML per 3 ML Pen Injector	SY	ce8354f4-bf07-4923-8755-47f3163662e4	3
242120	insulin, analog lispro 100 UNT/ML Injectable Solution	SY	ce8354f4-bf07-4923-8755-47f3163662e4	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0002-7516-01	00002751601	3 mL in 1 CARTRIDGE	3 ml					Historical
0002-7516-59	00002751659	5 CARTRIDGE in 1 CARTON (0002-7516-59) / 3 mL in 1 CARTRIDGE (0002-7516-01)	5 cartridge	2000-07-26	0000-00-00	No	No	Current
0002-7516-99	00002751699	5 CARTRIDGE in 1 CARTON (0002-7516-99) / 3 mL in 1 CARTRIDGE	5 cartridge	2000-07-26	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Humalog	Eli Lilly and Company	2026-01-09	HUMAN PRESCRIPTION DRUG LABEL	86
Humalog	Physicians Total Care, Inc.	2012-05-22	HUMAN PRESCRIPTION DRUG LABEL	3

Humalog

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#