FDA.reportPublic FDA data

NovoLog

Product NDC
64725-0750
11-digit product format
647250750
Labeler code
64725
Product ID
64725-0750_f92b7a9d-49f8-4b5e-9598-7d2c606ff62f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin aspart
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
TYA Pharmaceuticals
Application
NDA020986
Marketing category
NDA
Marketing start
2001-08-27
Marketing end
0000-00-00
Substance
INSULIN ASPART
Active strength
100 [iU]/mL
Pharmacologic classes
Insulin [CS],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
24eab60a-55c8-40c1-8c86-7ed01a7a8befProduct name120240227
09fb02dd-baf0-4f67-b464-599bf26324b6Product name220200323
6a6ef80c-37d6-4e02-aa78-fce7b811234eProduct name220200323
91ae268d-ee0f-6988-629d-5065a4376a50Product name220200323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64725-0750-12019-11-27C16284748780-19855e2a2-4bae-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use NovoLog safely and effectively. See full prescribing information for NovoLog. NovoLog (insulin aspart [rDNA origin] injection) solution for subcutaneous use Initial U.S. Approval: 2000 ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-0750-1NovoLog10 mL in 1 VIAL, GLASSINJECTION, SOLUTION102

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INSULIN ASPARTACTIVE INGREDIENTD933668QVXNOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [TYA PHARMACEUTICALS]2
INSULIN ASPARTACTIVE MOIETYD933668QVXNOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [TYA PHARMACEUTICALS]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [TYA PHARMACEUTICALS]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBNOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [TYA PHARMACEUTICALS]2
METACRESOLINACTIVE INGREDIENTGGO4Y809LONOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [TYA PHARMACEUTICALS]2
PHENOLINACTIVE INGREDIENT339NCG44TVNOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [TYA PHARMACEUTICALS]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [TYA PHARMACEUTICALS]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [TYA PHARMACEUTICALS]2
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2TNOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [TYA PHARMACEUTICALS]2
ZINCINACTIVE INGREDIENTJ41CSQ7QDSNOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-0750NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20140927_66472b3d-32c1-4803-aff4-b621aa5430b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311040insulin aspart 100 UNT/ML Injectable SolutionPSN66472b3d-32c1-4803-aff4-b621aa5430b32
351926NovoLOG 100 UNT/ML Injectable SolutionPSN66472b3d-32c1-4803-aff4-b621aa5430b32
351926insulin aspart, human 100 UNT/ML Injectable Solution [NovoLog]SBD66472b3d-32c1-4803-aff4-b621aa5430b32
311040insulin aspart, human 100 UNT/ML Injectable SolutionSCD66472b3d-32c1-4803-aff4-b621aa5430b32
311040insulin analog, aspart 100 UNT/ML Injectable SolutionSY66472b3d-32c1-4803-aff4-b621aa5430b32
351926NovoLog 100 UNT/ML Injectable SolutionSY66472b3d-32c1-4803-aff4-b621aa5430b32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
64725-0750-16472507500110 mL in 1 VIAL, GLASS10 mlHistorical