FDA.reportPublic FDA data

Humalog

Product NDC
55045-3602
11-digit product format
550453602
Labeler code
55045
Product ID
55045-3602_0b67b87e-09b2-4469-846e-52ea3f962018
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Insulin lispro
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Dispensing Solutions, Inc.
Application
NDA020563
Marketing category
NDA
Marketing start
1996-07-24
Marketing end
0000-00-00
Substance
INSULIN LISPRO
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
a42609d2-d76b-4c21-bc65-ace5fa0da69dProduct name120210105
0c5ba5d1-c81f-5bcc-49a8-b8e264edfb14Product name320200325
4477e8cc-8057-4880-8829-dfea528a2efaProduct name220200325

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55045-3602-12019-11-13C16284748780-197449f38-d163-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use HUMALOG safely and effectively. See full prescribing information for HUMALOG. Humalog (insulin lispro injection, USP [rDNA origin]) for injection Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55045-3602-1Humalog1 in 1 CARTONINJECTION, SOLUTION12
55045-3602-1Humalog10 mL in 1 VIALINJECTION, SOLUTION102

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Insulin lisproACTIVE INGREDIENTGFX7QIS1IIHUMALOG (INSULIN LISPRO) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]2
Insulin lisproACTIVE MOIETYGFX7QIS1IIHUMALOG (INSULIN LISPRO) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]2
GlycerinINACTIVE INGREDIENTPDC6A3C0OXHUMALOG (INSULIN LISPRO) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]2
Hydrochloric acidINACTIVE INGREDIENTQTT17582CBHUMALOG (INSULIN LISPRO) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]2
MetacresolINACTIVE INGREDIENTGGO4Y809LOHUMALOG (INSULIN LISPRO) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]2
PhenolINACTIVE INGREDIENT339NCG44TVHUMALOG (INSULIN LISPRO) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]2
Sodium hydroxideINACTIVE INGREDIENT55X04QC32IHUMALOG (INSULIN LISPRO) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]2
Sodium Phosphate, DibasicINACTIVE INGREDIENTGR686LBA74HUMALOG (INSULIN LISPRO) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RHUMALOG (INSULIN LISPRO) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]2
ZincINACTIVE INGREDIENTJ41CSQ7QDSHUMALOG (INSULIN LISPRO) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55045-3602HUMALOG (INSULIN LISPRO) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]2Legacy NDC, 2 package rows20120928_c5f75765-86b8-4926-b8c3-b42133ca7ac8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
865098HumaLOG 100 UNT/ML Injectable SolutionPSNc5f75765-86b8-4926-b8c3-b42133ca7ac82
242120insulin lispro 100 UNT/ML Injectable SolutionPSNc5f75765-86b8-4926-b8c3-b42133ca7ac82
865098insulin lispro 100 UNT/ML Injectable Solution [Humalog]SBDc5f75765-86b8-4926-b8c3-b42133ca7ac82
242120insulin lispro 100 UNT/ML Injectable SolutionSCDc5f75765-86b8-4926-b8c3-b42133ca7ac82
865098Humalog 100 UNT/ML Injectable SolutionSYc5f75765-86b8-4926-b8c3-b42133ca7ac82
242120insulin, analog lispro 100 UNT/ML Injectable SolutionSYc5f75765-86b8-4926-b8c3-b42133ca7ac82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55045-3602-1550453602011 in 1 CARTONHistorical