FDA.reportPublic FDA data

Lantus

Product NDC
64725-2220
11-digit product format
647252220
Labeler code
64725
Product ID
64725-2220_7d9b3b09-2b30-40a4-8b37-38d2e6af3abf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin glargine
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
TYA Pharmaceuticals
Application
NDA021081
Marketing category
NDA
Marketing start
2009-09-23
Marketing end
0000-00-00
Substance
INSULIN GLARGINE
Active strength
100 [iU]/mL
Pharmacologic classes
Insulin [Chemical/Ingredient],Insulin Analog [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a9e2da77-dd6b-4b0e-9065-a13f87955fe1Product name120220720
5f5c996a-6aad-4f9a-86a2-e09dc8b634cbProduct name120220207
1c45812e-8815-4d17-83e9-a18ac8df9badProduct name120210105
256d5b66-c6d0-4302-bcdf-00cf53e72c3bProduct name220200323
2e66a9ce-feca-49d1-97e2-3bec86a60bd8Product name220200323
e43198b7-315b-480b-8517-8809d5ca232aProduct name220200323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64725-2220-12019-11-27C16284748780-19855e2a2-470d-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine [rDNA origin] injection) solution for subcutaneous injection Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-2220-1Lantus10 mL in 1 VIAL, GLASSINJECTION, SOLUTION102

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
insulin glargineACTIVE INGREDIENT2ZM8CX04RZLANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [TYA PHARMACEUTICALS]2
insulin glargineACTIVE MOIETY2ZM8CX04RZLANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [TYA PHARMACEUTICALS]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [TYA PHARMACEUTICALS]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [TYA PHARMACEUTICALS]2
METACRESOLINACTIVE INGREDIENTGGO4Y809LOLANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [TYA PHARMACEUTICALS]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [TYA PHARMACEUTICALS]2
WATERINACTIVE INGREDIENT059QF0KO0RLANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [TYA PHARMACEUTICALS]2
ZINCINACTIVE INGREDIENTJ41CSQ7QDSLANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-2220LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20140927_6c81d894-67eb-4c68-8af1-8cc220adb6f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311041insulin glargine 100 UNT/ML Injectable SolutionPSN6c81d894-67eb-4c68-8af1-8cc220adb6f52
285018Lantus 100 UNT/ML Injectable SolutionPSN6c81d894-67eb-4c68-8af1-8cc220adb6f52
285018insulin glargine 100 UNT/ML Injectable Solution [Lantus]SBD6c81d894-67eb-4c68-8af1-8cc220adb6f52
311041insulin glargine 100 UNT/ML Injectable SolutionSCD6c81d894-67eb-4c68-8af1-8cc220adb6f52
311041insulin analog, glargine 100 UNT/ML Injectable SolutionSY6c81d894-67eb-4c68-8af1-8cc220adb6f52
285018Lantus 100 UNT/ML Injectable SolutionSY6c81d894-67eb-4c68-8af1-8cc220adb6f52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
64725-2220-16472522200110 mL in 1 VIAL, GLASS10 mlHistorical