LYUMJEV

Product NDC: 0002-8351
11-digit product format: 000028351
Labeler code: 0002
Product ID: 0002-8351_567d0b77-239e-4a05-9d84-8364e0e1ef7a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Insulin lispro-aabc
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Eli Lilly and Company
Application: BLA761109
Marketing category: BLA
Marketing start: 2020-06-15
Substance: INSULIN LISPRO
Active strength: 100 [iU]/mL
Pharmacologic classes: Insulin Analog [EPC], Insulin [Chemical/Ingredient]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 4 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
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	0002-8351-05	`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	0002-8351-05	`557ba5c1ecfa…`	`9c80585c8c6e…`

Additional Listing Data#

Finished product: Yes
Brand name base: LYUMJEV
Brand name suffix: Junior KwikPen
Listing expiration: 2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
GFX7QIS1II	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
c5a056e2-b568-4ca6-9ed8-79c010942d00	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d31d7280-9cbd-4e8c-ad8c-a830d9d6c4bf	Product name	1	20260309
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
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
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0002-8351-01	LYUMJEVJunior KwikPen	3 mL in 1 SYRINGE	INJECTION, SOLUTION	3		11
0002-8351-05	LYUMJEVJunior KwikPen	5 in 1 CARTON	INJECTION, SOLUTION	5		11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0002-8351	LYUMJEV (INSULIN LISPRO-AABC) INJECTION, SOLUTION LYUMJEV KWIKPEN (INSULIN LISPRO-AABC) INJECTION, SOLUTION LYUMJEV JUNIOR KWIKPEN (INSULIN LISPRO-AABC) INJECTION, SOLUTION LYUMJEV TEMPO PEN (INSULIN LISPRO-AABC) INJECTION, SOLUTION LYUMJEV KWIKPEN (INSULIN LISPRO-AABC) INJECTION, SOLUTION [ELI LILLY AND COMPANY]	10	Current NDC, Legacy NDC, 2 package rows	20241027_c5a056e2-b568-4ca6-9ed8-79c010942d00.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LYUMJEV	INSULIN LISPRO-AABC	A-S Medication Solutions	616daea1-0b79-4970-a141-6f99f2072f02	2026-04-13	Warnings, Adverse reactions	Exact identifier application number: BLA761109
LYUMJEV	INSULIN LISPRO-AABC	Eli Lilly and Company	c5a056e2-b568-4ca6-9ed8-79c010942d00	2025-12-30	Warnings, Adverse reactions	Exact identifier application number: BLA761109 ndc (product): 0002-8351

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761109	Lyumjev	insulin lispro-aabc	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
2380248	insulin lispro-aabc 100 UNT in 3 ML Cartridge	PSN	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380259	insulin lispro-aabc 100 UNT/ML in 3 ML Pen Injector	PSN	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380267	insulin lispro-aabc 100 UNT/ML in 3 ML Pen Injector with Sensor	PSN	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380265	insulin lispro-aabc 100 UNT/ML in 3 ML Pen Injector, 0.5 UNT Doses	PSN	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380231	insulin lispro-aabc 100 UNT/ML Injectable Solution	PSN	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380254	insulin lispro-aabc 200 UNT/ML in 3 ML Pen Injector	PSN	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380250	LYUMJEV 100 UNT/ML in 3 ML Cartridge	PSN	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380260	LYUMJEV 100 UNT/ML in 3 ML Pen Injector	PSN	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380266	LYUMJEV 100 UNT/ML in 3 ML Pen Injector, 0.5 UNT Doses	PSN	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380236	LYUMJEV 100 UNT/ML Injectable Solution	PSN	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380256	LYUMJEV 200 UNT/ML in 3 ML Pen Injector	PSN	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380268	LYUMJEV Tempo 100 UNT/ML in 3 ML Pen Injector	PSN	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380266	0.5 UNT Doses 3 ML insulin lispro-aabc 100 UNT/ML Pen Injector [Lyumjev]	SBD	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380250	3 ML insulin lispro-aabc 100 UNT/ML Cartridge [Lyumjev]	SBD	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380260	3 ML insulin lispro-aabc 100 UNT/ML Pen Injector [Lyumjev]	SBD	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380256	3 ML insulin lispro-aabc 200 UNT/ML Pen Injector [Lyumjev]	SBD	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380236	insulin lispro-aabc 100 UNT/ML Injectable Solution [Lyumjev]	SBD	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380268	Sensor 3 ML insulin lispro-aabc 100 UNT/ML Pen Injector [Lyumjev]	SBD	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380265	0.5 UNT Doses 3 ML insulin lispro-aabc 100 UNT/ML Pen Injector	SCD	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380248	3 ML insulin lispro-aabc 100 UNT/ML Cartridge	SCD	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380259	3 ML insulin lispro-aabc 100 UNT/ML Pen Injector	SCD	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380254	3 ML insulin lispro-aabc 200 UNT/ML Pen Injector	SCD	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380231	insulin lispro-aabc 100 UNT/ML Injectable Solution	SCD	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380267	Sensor 3 ML insulin lispro-aabc 100 UNT/ML Pen Injector	SCD	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380250	3 ML Lyumjev 100 UNT/ML Cartridge	SY	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380260	3 ML Lyumjev 100 UNT/ML Pen Injector	SY	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380256	3 ML Lyumjev 200 UNT/ML Pen Injector	SY	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380248	insulin lispro-aabc 100 UNT per 3 ML Cartridge	SY	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380259	insulin lispro-aabc 100 UNT/ML per 3 ML Pen Injector	SY	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380267	insulin lispro-aabc 100 UNT/ML per 3 ML Pen Injector with Sensor	SY	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380265	insulin lispro-aabc 100 UNT/ML per 3 ML Pen Injector, 0.5 UNT Doses	SY	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380254	insulin lispro-aabc 200 UNT/ML per 3 ML Pen Injector	SY	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380236	Lyumjev 100 UNT/ML Injectable Solution	SY	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380250	Lyumjev 100 UNT/ML per 3 ML Cartridge	SY	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380260	LYUMJEV 100 UNT/ML per 3 ML Pen Injector	SY	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380266	LYUMJEV 100 UNT/ML per 3 ML Pen Injector, 0.5 UNT Doses	SY	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380256	Lyumjev 200 UNT/ML per 3 ML Pen Injector	SY	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380268	Lyumjev Tempo 100 UNT/ML per 3 ML Pen Injector	SY	c5a056e2-b568-4ca6-9ed8-79c010942d00	11
2380268	Sensor 3 ML Lyumjev 100 UNT/ML Pen Injector	SY	c5a056e2-b568-4ca6-9ed8-79c010942d00	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0002-8351-01	00002835101	3 mL in 1 SYRINGE	3 ml					Historical
0002-8351-05	00002835105	5 SYRINGE in 1 CARTON (0002-8351-05) / 3 mL in 1 SYRINGE (0002-8351-01)	5 syringe	2020-06-15	0000-00-00	No	No	Current