Lantus

Product NDC: 0088-2220
11-digit product format: 000882220
Labeler code: 0088
Product ID: 0088-2220_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
Listing expiration: 2026-12-31

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
285018	Internal RxNorm lookup
311041	Internal RxNorm lookup
847230	Internal RxNorm lookup
847232	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
d5e07a0c-7e14-4756-9152-9fea485d654a	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
0088-2220-33	Lantus	10 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	10	35
0088-2220-33	Lantus	1 in 1 CARTON	INJECTION, SOLUTION	1	35
0088-2220-34	Lantus	10 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	10	35
0088-2220-34	Lantus	1 in 1 CARTON	INJECTION, SOLUTION	1	35

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0088-2220-33	ML - Milliliter	0088-2220	0def01d8-523e-42f3-8e2e-19e1d71bb8c7	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 GLARGINE) INJECTION, SOLUTION [TYA PHARMACEUTICALS]	2
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 GLARGINE) INJECTION, SOLUTION [TYA PHARMACEUTICALS]	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 GLARGINE) INJECTION, SOLUTION [TYA PHARMACEUTICALS]	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
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [TYA PHARMACEUTICALS]	2
METACRESOL	INACTIVE INGREDIENT	GGO4Y809LO	LANTUS (INSULIN GLARGIN) INJECTION, SOLUTION LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
METACRESOL	INACTIVE INGREDIENT	GGO4Y809LO	LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [TYA PHARMACEUTICALS]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	LANTUS (INSULIN GLARGIN) INJECTION, SOLUTION LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [TYA PHARMACEUTICALS]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	LANTUS (INSULIN GLARGIN) INJECTION, SOLUTION LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [TYA PHARMACEUTICALS]	2
ZINC	INACTIVE INGREDIENT	J41CSQ7QDS	LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [TYA PHARMACEUTICALS]	2
ZINC	INACTIVE INGREDIENT	J41CSQ7QDS	LANTUS (INSULIN GLARGIN) INJECTION, SOLUTION LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
insulin glargine	ACTIVE INGREDIENT	2ZM8CX04RZ	LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]	1
insulin glargine	ACTIVE MOIETY	2ZM8CX04RZ	LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]	1
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]	1
METACRESOL	INACTIVE INGREDIENT	GGO4Y809LO	LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]	1
zinc	INACTIVE INGREDIENT	J41CSQ7QDS	LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0088-2220	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

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lantus Solostar	INSULIN GLARGINE	sanofi-aventis U.S. LLC	d5e07a0c-7e14-4756-9152-9fea485d654a	2025-06-02	Warnings, Adverse reactions	Exact identifier application number: BLA021081 ndc (product): 0088-2220
Insulin Glargine Solostar	INSULIN GLARGINE	A-S Medication Solutions	9835904f-64f5-42b3-9ac9-89e4aaa5182a	2023-11-01	Warnings, Adverse reactions	Exact identifier application number: BLA021081
LANTUS SOLOSTAR	INSULIN GLARGINE	A-S Medication Solutions	3a97c40f-0c83-42d7-a8ee-484b208db4e3	2023-07-22	Warnings, Adverse reactions	Exact identifier application number: BLA021081
Lantus Solostar	INSULIN GLARGINE	A-S Medication Solutions	632d9f68-f184-43d5-b184-a3af23f12ad9	2023-06-06	Warnings, Adverse reactions	Exact identifier application number: BLA021081
Lantus	INSULIN GLARGINE	A-S Medication Solutions	ae27bb66-5dbe-4f01-a89e-f4fa7cb09c99	2023-02-04	Warnings, Adverse reactions	Exact identifier application number: BLA021081

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
021081	Lantus	insulin glargine	351(a)	Rx	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
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
311041	insulin glargine 100 UNT/ML Injectable Solution	PSN	ae27bb66-5dbe-4f01-a89e-f4fa7cb09c99	12
285018	Lantus 100 UNT/ML Injectable Solution	PSN	ae27bb66-5dbe-4f01-a89e-f4fa7cb09c99	12
285018	insulin glargine 100 UNT/ML Injectable Solution [Lantus]	SBD	ae27bb66-5dbe-4f01-a89e-f4fa7cb09c99	12
311041	insulin glargine 100 UNT/ML Injectable Solution	SCD	ae27bb66-5dbe-4f01-a89e-f4fa7cb09c99	12
311041	insulin analog, glargine 100 UNT/ML Injectable Solution	SY	ae27bb66-5dbe-4f01-a89e-f4fa7cb09c99	12
285018	Lantus 100 UNT/ML Injectable Solution	SY	ae27bb66-5dbe-4f01-a89e-f4fa7cb09c99	12
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	6c81d894-67eb-4c68-8af1-8cc220adb6f5	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	6c81d894-67eb-4c68-8af1-8cc220adb6f5	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
285018	insulin glargine 100 UNT/ML Injectable Solution [Lantus]	SBD	6c81d894-67eb-4c68-8af1-8cc220adb6f5	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
311041	insulin glargine 100 UNT/ML Injectable Solution	SCD	6c81d894-67eb-4c68-8af1-8cc220adb6f5	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
311041	insulin analog, glargine 100 UNT/ML Injectable Solution	SY	6c81d894-67eb-4c68-8af1-8cc220adb6f5	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	6c81d894-67eb-4c68-8af1-8cc220adb6f5	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
311041	insulin glargine 100 UNT/ML Injectable Solution	PSN	f2149727-c2df-41b0-97f1-45ea75e0aa1a	1
285018	Lantus 100 UNT/ML Injectable Solution	PSN	f2149727-c2df-41b0-97f1-45ea75e0aa1a	1
285018	insulin glargine 100 UNT/ML Injectable Solution [Lantus]	SBD	f2149727-c2df-41b0-97f1-45ea75e0aa1a	1
311041	insulin glargine 100 UNT/ML Injectable Solution	SCD	f2149727-c2df-41b0-97f1-45ea75e0aa1a	1
311041	insulin analog, glargine 100 UNT/ML Injectable Solution	SY	f2149727-c2df-41b0-97f1-45ea75e0aa1a	1
285018	Lantus 100 UNT/ML Injectable Solution	SY	f2149727-c2df-41b0-97f1-45ea75e0aa1a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0088-2220-33	00088222033	1 VIAL, GLASS in 1 CARTON (0088-2220-33) / 10 mL in 1 VIAL, GLASS	2009-09-23	0000-00-00	No	No	Current
0088-2220-34	00088222034	1 VIAL, GLASS in 1 CARTON (0088-2220-34) / 10 mL in 1 VIAL, GLASS	2009-09-23	0000-00-00	Yes	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	A-S Medication Solutions	2023-02-04	HUMAN PRESCRIPTION DRUG LABEL	12
Lantus	REMEDYREPACK INC.	2019-02-14	HUMAN PRESCRIPTION DRUG LABEL	1
Lantus	TYA Pharmaceuticals	2014-01-09	HUMAN PRESCRIPTION DRUG LABEL	2
Lantus	Dispensing Solutions, Inc.	2011-09-20	HUMAN PRESCRIPTION DRUG LABEL	1
Lantus	Physicians Total Care, Inc.	2010-01-05	HUMAN PRESCRIPTION DRUG LABEL	2