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 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
0088-2220-33	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

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	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

Lantus

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#