Levemir

Product NDC
68258-8977
11-digit product format
682588977
Labeler code
68258
Product ID
68258-8977_082bc713-cea6-4af8-b2be-65622cb897d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin detemir
Dosage form
IMPLANT
Route
SOFT TISSUE
Labeler
Dispensing Solutions, Inc.
Application
NDA021536
Marketing category
NDA
Marketing start
2006-03-27
Marketing end
0000-00-00
Substance
INSULIN DETEMIR
Active strength
14 mg/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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68258-8977-12019-10-29C16284748780-1960f7f55-cfec-8e05-e053-dbdaa90a074aLevemir ® (insulin detemir [rDNA origin] injection)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68258-8977-1Levemir10 mL in 1 VIALIMPLANT101
68258-8977-1Levemir1 in 1 CARTONIMPLANT11

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68258-8977LEVEMIR (INSULIN DETEMIR) IMPLANT [DISPENSING SOLUTIONS, INC.]1Legacy NDC, 2 package rows20110930_2b8d9730-686b-444b-9941-7b5877255924.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484322insulin detemir 100 UNT/ML Injectable SolutionPSN2b8d9730-686b-444b-9941-7b58772559241
616238Levemir 100 UNT/ML Injectable SolutionPSN2b8d9730-686b-444b-9941-7b58772559241
616238insulin detemir 100 UNT/ML Injectable Solution [Levemir]SBD2b8d9730-686b-444b-9941-7b58772559241
484322insulin detemir 100 UNT/ML Injectable SolutionSCD2b8d9730-686b-444b-9941-7b58772559241
484322insulin analog, detemir 100 UNT/ML Injectable SolutionSY2b8d9730-686b-444b-9941-7b58772559241
616238Levemir 100 UNT/ML Injectable SolutionSY2b8d9730-686b-444b-9941-7b58772559241
616238Levemir 14.2 MG/ML Injectable SolutionSY2b8d9730-686b-444b-9941-7b58772559241

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
68258-8977-16825889770110 mL in 1 VIAL10 mlHistorical