FDA.reportPublic FDA data

NDC 0088-2219-01 - Lantus

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0088-2219
Requested NDC
0088-2219-01
Package NDCs from labels
0088-2219-00, 0088-2219-01, 0088-2219-05
Manufacturer
sanofi-aventis U.S. LLC | Sanofi S.r.l. | Sanofi-Aventis Deutschland GmbH
Effective date
2025-06-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ZINC - sanofi-aventis U.S. LLC | Sanofi S.r.l. | Sanofi-Aventis Deutschland GmbHsanofi-aventis U.S. LLC | Sanofi S.r.l. | Sanofi-Aventis Deutschland GmbH2025-06-02HUMAN PRESCRIPTION DRUG LABEL
LANTUS SOLOSTAR - A-S Medication SolutionsA-S Medication Solutions2023-07-22HUMAN PRESCRIPTION DRUG LABEL
Lantus Solostar - A-S Medication SolutionsA-S Medication Solutions2023-06-06HUMAN PRESCRIPTION DRUG LABEL
Lantus Solostar - REMEDYREPACK INC.REMEDYREPACK INC.2021-05-17HUMAN PRESCRIPTION DRUG LABEL
Lantus - Physicians Total Care, Inc.Physicians Total Care, Inc.2010-01-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0088-2219-00Lantus Solostar1 in 1 CARTONINJECTION, SOLUTION135
0088-2219-00Lantus Solostar3 mL in 1 SYRINGEINJECTION, SOLUTION335
0088-2219-01Lantus Solostar3 mL in 1 SYRINGEINJECTION, SOLUTION335
0088-2219-05Lantus Solostar5 in 1 CARTONINJECTION, SOLUTION535

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0088-2219LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION LANTUS SOLOSTAR (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]34Current NDC, Legacy NDC, 4 package rows20240530_d5e07a0c-7e14-4756-9152-9fea485d654a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0088-2219-00ML - Milliliter0088-2219dba3e89a-e1c2-49eb-b845-f8e856d9090412017-08-11
0088-2219-01ML - Milliliter0088-22190d4e9964-b8a1-4e06-b6e0-6623b98ca46d12020-04-20
0088-2219-05ML - Milliliter0088-2219bfcea8f5-d6d3-4363-81f1-a247cd66747012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
insulin glargineACTIVE INGREDIENT2ZM8CX04RZLANTUS (INSULIN GLARGINE) INJECTION, SOLUTION LANTUS SOLOSTAR (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]22
insulin glargineACTIVE MOIETY2ZM8CX04RZLANTUS (INSULIN GLARGINE) INJECTION, SOLUTION LANTUS SOLOSTAR (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]22
glycerinINACTIVE INGREDIENTPDC6A3C0OXLANTUS (INSULIN GLARGINE) INJECTION, SOLUTION LANTUS SOLOSTAR (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]22
hydrochloric acidINACTIVE INGREDIENTQTT17582CBLANTUS (INSULIN GLARGINE) INJECTION, SOLUTION LANTUS SOLOSTAR (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]22
METACRESOLINACTIVE INGREDIENTGGO4Y809LOLANTUS (INSULIN GLARGINE) INJECTION, SOLUTION LANTUS SOLOSTAR (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]22
sodium hydroxideINACTIVE INGREDIENT55X04QC32ILANTUS (INSULIN GLARGINE) INJECTION, SOLUTION LANTUS SOLOSTAR (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]22
waterINACTIVE INGREDIENT059QF0KO0RLANTUS (INSULIN GLARGINE) INJECTION, SOLUTION LANTUS SOLOSTAR (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]22
zincINACTIVE INGREDIENTJ41CSQ7QDSLANTUS (INSULIN GLARGINE) INJECTION, SOLUTION LANTUS SOLOSTAR (INSULIN GLARGINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]22
INSULIN GLARGINEACTIVE INGREDIENT2ZM8CX04RZLANTUS (INSULIN GLARGIN) INJECTION, SOLUTION LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
INSULIN GLARGINEACTIVE MOIETY2ZM8CX04RZLANTUS (INSULIN GLARGIN) INJECTION, SOLUTION LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLANTUS (INSULIN GLARGIN) INJECTION, SOLUTION LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLANTUS (INSULIN GLARGIN) INJECTION, SOLUTION LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
METACRESOLINACTIVE INGREDIENTGGO4Y809LOLANTUS (INSULIN GLARGIN) INJECTION, SOLUTION LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILANTUS (INSULIN GLARGIN) INJECTION, SOLUTION LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RLANTUS (INSULIN GLARGIN) INJECTION, SOLUTION LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
ZINCINACTIVE INGREDIENTJ41CSQ7QDSLANTUS (INSULIN GLARGIN) INJECTION, SOLUTION LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]2

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 9 of 37 · 731 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Formula II Drops 2090PAIN FORMULA II DROPSProfessional Complementary Health Formulasb395d69b-8e6b-4ffc-9d6e-2ecd503aa1772026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Endotoxin Terrain Drops 2143ENDOTOXIN TERRAIN DROPSProfessional Complementary Health Formulas58842566-005a-48b5-973d-20cde2fbd7012026-01-08WarningsExact identifier
unii: QTT17582CB
Adrenal Liquescence 3001ADRENAL LIQUESCENCEProfessional Complementary Health Formulas0388d3c7-4b3b-4e74-8c1b-9a2af2a4377d2026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Hysteria Drops 2119HYSTERIA DROPSProfessional Complementary Health Formulas7fe11cce-22f4-47e8-8006-ff5b2b2b23712026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Memory Drops 2043MEMORY DROPSProfessional Complementary Health Formulasa9b8897b-e5a1-4db3-94dd-8012aded6ed72026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Preparation H Rapid ReliefGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC49a93cfc-4ccd-4ef3-928f-901b9926f7942026-01-08WarningsExact identifier
unii: PDC6A3C0OX
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
LemonGLYCERINSion Biotext Medical Ltddbd7ed86-1b92-4471-827a-89f3afa1b0dc2026-01-08WarningsExact identifier
unii: PDC6A3C0OX
Male Endocrine Axis Drops 5019MALE ENDOCRINE AXIS DROPSProfessional Complementary Health Formulas607dd42d-5b41-4c0a-8499-83763dc04ad12026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Epilepsy Drops 2020EPILEPSY DROPSProfessional Complementary Health Formulasb5cc19d2-5200-498c-9742-5967d90479282026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Mycotoxin Inhibitor 6020MYCOTOXIN INHIBITORProfessional Complementary Health Formulasb9e7062b-f5e0-462a-8192-215c5a6472202026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Cataract Drops 2085CATARACT DROPSProfessional Complementary Health Formulas6040a096-ccdb-4e1e-a242-be29c3127f272026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Insomnia Drops 2035INSOMNIA DROPSProfessional Complementary Health Formulas49dcc73f-2a20-4938-8671-0fa9dd39d5b82026-01-08WarningsExact identifier
unii: J41CSQ7QDS
RET Thyroid/Adrenal 7011RET THYROID/ADRENALProfessional Complementary Health Formulaseb313eb9-4dfc-402e-92b3-14f09f4ba8692026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Neuro Relax Drops 2055NEURO RELAX DROPSProfessional Complementary Health Formulas50cf1c24-4ae9-42e8-a2a3-4d83cc5bfb5a2026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Glycerin Combination 9304GLYCERIN COMBINATIONProfessional Complementary Health Formulas391d8517-9b89-4b62-97b5-5102b35bec462026-01-08WarningsExact identifier
unii: PDC6A3C0OX
Echinacea Combination 9222ECHINACEA COMBINATIONProfessional Complementary Health Formulas430cc9f6-5565-4345-ac5f-d948fb3b14bd2026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Libido Stim Liquescence 3014LIBIDO STIM LIQUESCENCEProfessional Complementary Health Formulas3d59b77d-817b-4021-a6dd-75d3b4b608662026-01-08WarningsExact identifier
unii: PDC6A3C0OX
Insulin 1556INSULINProfessional Complementary Health Formulas88170080-374d-456e-90bc-48e873878ce72026-01-08WarningsExact identifier
unii: 2ZM8CX04RZ

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.