Humalog

Product NDC: 0002-8213
11-digit product format: 000028213
Labeler code: 0002
Product ID: 0002-8213_d0a38a0f-9d29-44eb-bfd1-c83cbcba1008
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Insulin lispro
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Eli Lilly and Company
Application: BLA020563
Marketing category: BLA
Marketing start: 2017-06-06
Marketing end: 2027-04-04
Substance: INSULIN LISPRO
Active strength: 100 [iU]/mL
Pharmacologic classes: Insulin Analog [EPC], Insulin [Chemical/Ingredient]
NDC exclude flag: No
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Humalog
Brand name suffix: Tempo Pen

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
GFX7QIS1II	Internal UNII lookup
059QF0KO0R	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	Available on FDA.report

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
0002-8213-05	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
0002-8213-05	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	Strength	SPL version
0002-8213-01	Humalog Tempo Pen	3 mL in 1 SYRINGE	INJECTION, SOLUTION	3		86
0002-8213-05	Humalog Tempo Pen	5 in 1 CARTON	INJECTION, SOLUTION	5		86

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0002-8213-01	ML - Milliliter	0002-8213	6f786b57-b00a-4f62-8108-ef4db32ff3e2	1	2022-12-07
0002-8213-05	ML - Milliliter	0002-8213	772ea103-9ef7-4c2f-9c03-0e87765b1a7f	1	2022-12-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Insulin lispro	ACTIVE INGREDIENT	GFX7QIS1II	HUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]	49
Insulin lispro	ACTIVE MOIETY	GFX7QIS1II	HUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]	49
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	HUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]	49
Hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	HUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]	49
Metacresol	INACTIVE INGREDIENT	GGO4Y809LO	HUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]	49
Phenol	INACTIVE INGREDIENT	339NCG44TV	HUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]	49
Sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	HUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]	49
Sodium Phosphate, Dibasic	INACTIVE INGREDIENT	GR686LBA74	HUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]	49
Tromethamine	INACTIVE INGREDIENT	023C2WHX2V	HUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]	49
Water	INACTIVE INGREDIENT	059QF0KO0R	HUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]	49
Zinc	INACTIVE INGREDIENT	J41CSQ7QDS	HUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]	49

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0002-8213	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, 2 package rows	20250523_c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f.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 · 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 ndc (product): 0002-8213
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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0002-8213-01	00002821301	3 mL in 1 SYRINGE	3 ml					Historical
0002-8213-05	00002821305	5 SYRINGE in 1 CARTON (0002-8213-05) / 3 mL in 1 SYRINGE (0002-8213-01)	5 syringe	2019-11-15	2027-04-04	No	No	Current