BASAGLAR

Product NDC: 0002-7715
Requested package NDC: 0002-7715-63
11-digit product format: 000027715
Labeler code: 0002
Product ID: 0002-7715_3c2283e6-2844-44d2-a447-579b07e77c27
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Insulin glargine
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Eli Lilly and Company
Application: BLA205692
Marketing category: BLA
Marketing start: 2015-12-16
Substance: INSULIN GLARGINE
Active strength: 100 [iU]/mL
Pharmacologic classes: Insulin Analog [EPC], Insulin [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0002-7715	0002-7715-63	D	Discontinued by firm		2026-08-17

Additional Listing Data#

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

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2ZM8CX04RZ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
847230	Internal RxNorm lookup
1736863	Internal RxNorm lookup
2268064	Internal RxNorm lookup
2268065	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a9e2da77-dd6b-4b0e-9065-a13f87955fe1	Product name	1	20220720
5f5c996a-6aad-4f9a-86a2-e09dc8b634cb	Product name	1	20220207
1c45812e-8815-4d17-83e9-a18ac8df9bad	Product name	1	20210105
256d5b66-c6d0-4302-bcdf-00cf53e72c3b	Product name	2	20200323
2e66a9ce-feca-49d1-97e2-3bec86a60bd8	Product name	2	20200323
e43198b7-315b-480b-8517-8809d5ca232a	Product name	2	20200323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0002-7715-01	BASAGLAR KwikPen	3 mL in 1 SYRINGE	INJECTION, SOLUTION	3	34
0002-7715-59	BASAGLAR KwikPen	5 in 1 CARTON	INJECTION, SOLUTION	5	34
0002-7715-63	BASAGLAR KwikPen	1 in 1 CARTON	INJECTION, SOLUTION	1	34
0002-7715-63	BASAGLAR KwikPen	3 mL in 1 SYRINGE	INJECTION, SOLUTION	3	34

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0002-7715-01	ML - Milliliter	0002-7715	f19d46e2-8a36-4216-84e6-fdc623fc462f	1	2016-12-07
0002-7715-59	ML - Milliliter	0002-7715	f559417a-8c83-4a9d-a058-9c2362cec1e4	1	2016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0002-7715	BASAGLAR KWIKPEN (INSULIN GLARGINE) INJECTION, SOLUTION BASAGLAR TEMPO PEN (INSULIN GLARGINE) INJECTION, SOLUTION [ELI LILLY AND COMPANY]	33	Current NDC, Legacy NDC, 4 package rows	20231214_0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae.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
BASAGLAR KwikPen	INSULIN GLARGINE	Eli Lilly and Company	0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae	2026-06-16	Warnings, Adverse reactions	Exact identifier application number: BLA205692 ndc (package): 0002-7715-63 ndc (product): 0002-7715 ndc11 (package): 00002771563

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
205692	Basaglar	insulin glargine	351(a)	Disc	2026-07-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2ZM8CX04RZ	INSULIN GLARGINE	160337-95-1	INSULIN GLARGINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1736863	Basaglar KwikPen 100 UNT/ML in 3 ML Pen Injector	PSN	0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae	34
2268065	Basaglar Tempo 100 UNT/ML in 3 ML Pen Injector	PSN	0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae	34
847230	insulin glargine 100 UNT/ML in 3 ML Pen Injector	PSN	0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae	34
2268064	insulin glargine 100 UNT/ML in 3 ML Pen Injector with Sensor	PSN	0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae	34
1736863	3 ML insulin glargine 100 UNT/ML Pen Injector [Basaglar]	SBD	0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae	34
2268065	Sensor 3 ML insulin glargine 100 UNT/ML Pen Injector [Basaglar]	SBD	0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae	34
847230	3 ML insulin glargine 100 UNT/ML Pen Injector	SCD	0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae	34
2268064	Sensor 3 ML insulin glargine 100 UNT/ML Pen Injector	SCD	0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae	34
1736863	3 ML Basaglar 100 UNT/ML Pen Injector	SY	0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae	34
847230	3 ML insulin analog, glargine 100 UNT/ML Pen Injector	SY	0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae	34
2268065	Basaglar 100 UNT/ML per 3 ML Pen Injector with Sensor	SY	0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae	34
1736863	Basaglar 300 UNT per 3 ML Pen Injector	SY	0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae	34
2268065	Basaglar 300 UNT per 3 ML Pen Injector with Sensor	SY	0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae	34
847230	insulin analog, glargine 300 UNT Pen Injector	SY	0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae	34
2268064	insulin glargine 100 UNT/ML per 3 ML Pen Injector with Sensor	SY	0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae	34
847230	insulin glargine 300 UNT per 3 ML Pen Injector	SY	0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae	34
2268064	insulin glargine 300 UNT per 3 ML Pen Injector with Sensor	SY	0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae	34

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0002-7715-63	00002771563	1 SYRINGE in 1 CARTON (0002-7715-63) / 3 mL in 1 SYRINGE	1 syringe	2016-07-15	0000-00-00	Yes	No	Current