Lantus Solostar

Product NDC: 0088-2219
11-digit product format: 000882219
Labeler code: 0088
Product ID: 0088-2219_4e220385-b760-4a64-a1ca-84bd2bebe448
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: insulin glargine
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: sanofi-aventis U.S. LLC
Application: BLA021081
Marketing category: BLA
Marketing start: 2009-09-23
Substance: INSULIN GLARGINE
Active strength: 100 [iU]/mL
Pharmacologic classes: Insulin Analog [EPC], Insulin [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Lantus Solostar
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	2ZM8CX04RZ
Rxcui	285018, 311041, 847230, 847232

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
0088-2219-00	Lantus Solostar	1 in 1 CARTON	INJECTION, SOLUTION	1	35
0088-2219-00	Lantus Solostar	3 mL in 1 SYRINGE	INJECTION, SOLUTION	3	35
0088-2219-01	Lantus Solostar	3 mL in 1 SYRINGE	INJECTION, SOLUTION	3	35
0088-2219-05	Lantus Solostar	5 in 1 CARTON	INJECTION, SOLUTION	5	35

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0088-2219-00	ML - Milliliter	0088-2219	dba3e89a-e1c2-49eb-b845-f8e856d90904	1	2017-08-11
0088-2219-01	ML - Milliliter	0088-2219	0d4e9964-b8a1-4e06-b6e0-6623b98ca46d	1	2020-04-20
0088-2219-05	ML - Milliliter	0088-2219	bfcea8f5-d6d3-4363-81f1-a247cd667470	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
insulin glargine	ACTIVE INGREDIENT	2ZM8CX04RZ	LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION LANTUS SOLOSTAR (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]	22
insulin glargine	ACTIVE MOIETY	2ZM8CX04RZ	LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION LANTUS SOLOSTAR (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]	22
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION LANTUS SOLOSTAR (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]	22
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION LANTUS SOLOSTAR (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]	22
METACRESOL	INACTIVE INGREDIENT	GGO4Y809LO	LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION LANTUS SOLOSTAR (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]	22
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION LANTUS SOLOSTAR (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]	22
water	INACTIVE INGREDIENT	059QF0KO0R	LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION LANTUS SOLOSTAR (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]	22
zinc	INACTIVE INGREDIENT	J41CSQ7QDS	LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION LANTUS SOLOSTAR (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]	22
INSULIN GLARGINE	ACTIVE INGREDIENT	2ZM8CX04RZ	LANTUS (INSULIN GLARGIN) INJECTION, SOLUTION LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
INSULIN GLARGINE	ACTIVE MOIETY	2ZM8CX04RZ	LANTUS (INSULIN GLARGIN) INJECTION, SOLUTION LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	LANTUS (INSULIN GLARGIN) INJECTION, SOLUTION LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	LANTUS (INSULIN GLARGIN) INJECTION, SOLUTION LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
METACRESOL	INACTIVE INGREDIENT	GGO4Y809LO	LANTUS (INSULIN GLARGIN) INJECTION, SOLUTION LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	LANTUS (INSULIN GLARGIN) INJECTION, SOLUTION LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	LANTUS (INSULIN GLARGIN) INJECTION, SOLUTION LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
ZINC	INACTIVE INGREDIENT	J41CSQ7QDS	LANTUS (INSULIN GLARGIN) INJECTION, SOLUTION LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0088-2219	LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION LANTUS SOLOSTAR (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]	34	Current NDC, Legacy NDC, 4 package rows	20240530_d5e07a0c-7e14-4756-9152-9fea485d654a.zip

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
847230	insulin glargine 100 UNT/ML in 3 ML Pen Injector	PSN	d5e07a0c-7e14-4756-9152-9fea485d654a	35
311041	insulin glargine 100 UNT/ML Injectable Solution	PSN	d5e07a0c-7e14-4756-9152-9fea485d654a	35
847232	Lantus 100 UNT/ML in 3 ML Pen Injector	PSN	d5e07a0c-7e14-4756-9152-9fea485d654a	35
285018	Lantus 100 UNT/ML Injectable Solution	PSN	d5e07a0c-7e14-4756-9152-9fea485d654a	35
847232	3 ML insulin glargine 100 UNT/ML Pen Injector [Lantus]	SBD	d5e07a0c-7e14-4756-9152-9fea485d654a	35
285018	insulin glargine 100 UNT/ML Injectable Solution [Lantus]	SBD	d5e07a0c-7e14-4756-9152-9fea485d654a	35
847230	3 ML insulin glargine 100 UNT/ML Pen Injector	SCD	d5e07a0c-7e14-4756-9152-9fea485d654a	35
311041	insulin glargine 100 UNT/ML Injectable Solution	SCD	d5e07a0c-7e14-4756-9152-9fea485d654a	35
847230	3 ML insulin analog, glargine 100 UNT/ML Pen Injector	SY	d5e07a0c-7e14-4756-9152-9fea485d654a	35
847232	3 ML Lantus 100 UNT/ML Pen Injector	SY	d5e07a0c-7e14-4756-9152-9fea485d654a	35
311041	insulin analog, glargine 100 UNT/ML Injectable Solution	SY	d5e07a0c-7e14-4756-9152-9fea485d654a	35
847230	insulin analog, glargine 300 UNT Pen Injector	SY	d5e07a0c-7e14-4756-9152-9fea485d654a	35
847230	insulin glargine 300 UNT per 3 ML Pen Injector	SY	d5e07a0c-7e14-4756-9152-9fea485d654a	35
285018	Lantus 100 UNT/ML Injectable Solution	SY	d5e07a0c-7e14-4756-9152-9fea485d654a	35
847232	Lantus 300 UNT per 3 ML OptiClik Pen	SY	d5e07a0c-7e14-4756-9152-9fea485d654a	35
847232	Lantus 300 UNT per 3 ML Pen Injector	SY	d5e07a0c-7e14-4756-9152-9fea485d654a	35
847232	Lantus 300 UNT per 3 ML SoloStar Pen	SY	d5e07a0c-7e14-4756-9152-9fea485d654a	35
847230	insulin glargine 100 UNT/ML in 3 ML Pen Injector	PSN	632d9f68-f184-43d5-b184-a3af23f12ad9	13
847232	Lantus 100 UNT/ML in 3 ML Pen Injector	PSN	632d9f68-f184-43d5-b184-a3af23f12ad9	13
847232	3 ML insulin glargine 100 UNT/ML Pen Injector [Lantus]	SBD	632d9f68-f184-43d5-b184-a3af23f12ad9	13
847230	3 ML insulin glargine 100 UNT/ML Pen Injector	SCD	632d9f68-f184-43d5-b184-a3af23f12ad9	13
847230	3 ML insulin analog, glargine 100 UNT/ML Pen Injector	SY	632d9f68-f184-43d5-b184-a3af23f12ad9	13
847232	3 ML Lantus 100 UNT/ML Pen Injector	SY	632d9f68-f184-43d5-b184-a3af23f12ad9	13
847230	insulin analog, glargine 300 UNT Pen Injector	SY	632d9f68-f184-43d5-b184-a3af23f12ad9	13
847230	insulin glargine 300 UNT per 3 ML Pen Injector	SY	632d9f68-f184-43d5-b184-a3af23f12ad9	13
847232	Lantus 300 UNT per 3 ML OptiClik Pen	SY	632d9f68-f184-43d5-b184-a3af23f12ad9	13
847232	Lantus 300 UNT per 3 ML Pen Injector	SY	632d9f68-f184-43d5-b184-a3af23f12ad9	13
847232	Lantus 300 UNT per 3 ML SoloStar Pen	SY	632d9f68-f184-43d5-b184-a3af23f12ad9	13
847230	insulin glargine 100 UNT/ML in 3 ML Pen Injector	PSN	3a97c40f-0c83-42d7-a8ee-484b208db4e3	6
847232	Lantus 100 UNT/ML in 3 ML Pen Injector	PSN	3a97c40f-0c83-42d7-a8ee-484b208db4e3	6
847232	3 ML insulin glargine 100 UNT/ML Pen Injector [Lantus]	SBD	3a97c40f-0c83-42d7-a8ee-484b208db4e3	6
847230	3 ML insulin glargine 100 UNT/ML Pen Injector	SCD	3a97c40f-0c83-42d7-a8ee-484b208db4e3	6
847230	3 ML insulin analog, glargine 100 UNT/ML Pen Injector	SY	3a97c40f-0c83-42d7-a8ee-484b208db4e3	6
847232	3 ML Lantus 100 UNT/ML Pen Injector	SY	3a97c40f-0c83-42d7-a8ee-484b208db4e3	6
847230	insulin analog, glargine 300 UNT Pen Injector	SY	3a97c40f-0c83-42d7-a8ee-484b208db4e3	6
847230	insulin glargine 300 UNT per 3 ML Pen Injector	SY	3a97c40f-0c83-42d7-a8ee-484b208db4e3	6
847232	Lantus 300 UNT per 3 ML OptiClik Pen	SY	3a97c40f-0c83-42d7-a8ee-484b208db4e3	6
847232	Lantus 300 UNT per 3 ML Pen Injector	SY	3a97c40f-0c83-42d7-a8ee-484b208db4e3	6
847232	Lantus 300 UNT per 3 ML SoloStar Pen	SY	3a97c40f-0c83-42d7-a8ee-484b208db4e3	6
847230	insulin glargine 100 UNT/ML in 3 ML Pen Injector	PSN	b861fdd9-e134-436e-8c0c-a60dd0006dd3	2
311041	insulin glargine 100 UNT/ML Injectable Solution	PSN	b861fdd9-e134-436e-8c0c-a60dd0006dd3	2
847232	Lantus 100 UNT/ML in 3 ML Pen Injector	PSN	b861fdd9-e134-436e-8c0c-a60dd0006dd3	2
285018	Lantus 100 UNT/ML Injectable Solution	PSN	b861fdd9-e134-436e-8c0c-a60dd0006dd3	2
847232	3 ML insulin glargine 100 UNT/ML Pen Injector [Lantus]	SBD	b861fdd9-e134-436e-8c0c-a60dd0006dd3	2
285018	insulin glargine 100 UNT/ML Injectable Solution [Lantus]	SBD	b861fdd9-e134-436e-8c0c-a60dd0006dd3	2
847230	3 ML insulin glargine 100 UNT/ML Pen Injector	SCD	b861fdd9-e134-436e-8c0c-a60dd0006dd3	2
311041	insulin glargine 100 UNT/ML Injectable Solution	SCD	b861fdd9-e134-436e-8c0c-a60dd0006dd3	2
847230	3 ML insulin analog, glargine 100 UNT/ML Pen Injector	SY	b861fdd9-e134-436e-8c0c-a60dd0006dd3	2
847232	3 ML Lantus 100 UNT/ML Pen Injector	SY	b861fdd9-e134-436e-8c0c-a60dd0006dd3	2
311041	insulin analog, glargine 100 UNT/ML Injectable Solution	SY	b861fdd9-e134-436e-8c0c-a60dd0006dd3	2
847230	insulin analog, glargine 300 UNT Pen Injector	SY	b861fdd9-e134-436e-8c0c-a60dd0006dd3	2
847230	insulin glargine 300 UNT per 3 ML Pen Injector	SY	b861fdd9-e134-436e-8c0c-a60dd0006dd3	2
285018	Lantus 100 UNT/ML Injectable Solution	SY	b861fdd9-e134-436e-8c0c-a60dd0006dd3	2
847232	Lantus 300 UNT per 3 ML OptiClik Pen	SY	b861fdd9-e134-436e-8c0c-a60dd0006dd3	2
847232	Lantus 300 UNT per 3 ML Pen Injector	SY	b861fdd9-e134-436e-8c0c-a60dd0006dd3	2
847232	Lantus 300 UNT per 3 ML SoloStar Pen	SY	b861fdd9-e134-436e-8c0c-a60dd0006dd3	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0088-2219-00	00088221900	1 SYRINGE in 1 CARTON (0088-2219-00) / 3 mL in 1 SYRINGE	1 syringe	2009-09-23	0000-00-00	Yes	No	Current
0088-2219-01	00088221901	3 mL in 1 SYRINGE	3 ml					Historical
0088-2219-05	00088221905	5 SYRINGE in 1 CARTON (0088-2219-05) / 3 mL in 1 SYRINGE (0088-2219-01)	5 syringe	2009-09-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lantus	sanofi-aventis U.S. LLC \| Sanofi S.r.l. \| Sanofi-Aventis Deutschland GmbH	2025-06-02	HUMAN PRESCRIPTION DRUG LABEL	35
LANTUS SOLOSTAR	A-S Medication Solutions	2023-07-22	HUMAN PRESCRIPTION DRUG LABEL	6
Lantus Solostar	A-S Medication Solutions	2023-06-06	HUMAN PRESCRIPTION DRUG LABEL	13
Lantus	Physicians Total Care, Inc.	2010-01-05	HUMAN PRESCRIPTION DRUG LABEL	2

Lantus Solostar

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#