Levorphanol Tartrate

Product NDC
69543-417
11-digit product format
695430417
Labeler code
69543
Product ID
69543-417_42f6d390-228a-4790-8372-2e822b5d7e9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levorphanol Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Virtus Pharmaceuticals, LLC
Application
ANDA211484
Marketing category
ANDA
Marketing start
2020-09-01
Marketing end
2027-07-31
Substance
LEVORPHANOL TARTRATE
Active strength
2 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levorphanol Tartrate

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVORPHANOL TARTRATE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04WQU6T9QI
Rxcui197873

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
34ec43f3-43ad-c434-04a6-9d47021af3a1Product name520220118

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69543-417-10Levorphanol Tartrate100 in 1 BOTTLETABLET1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69543-417-10EA - Each69543-417b46d0cf6-beb4-417b-9a21-a31dd8f08d1912020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69543-417LEVORPHANOL TARTRATE TABLET [VIRTUS PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 1 package rows20240905_6e7ca993-c8b9-4510-a2b0-5bcc678d2571.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197873levorphanol tartrate 2 MG Oral TabletPSNdeed8652-9b9d-48b4-8c3e-9fdd7c46237e102
197873levorphanol tartrate 2 MG Oral TabletSCDdeed8652-9b9d-48b4-8c3e-9fdd7c46237e102
197873levorphanol tartrate 2 MG Oral TabletPSN6e7ca993-c8b9-4510-a2b0-5bcc678d25714
197873levorphanol tartrate 2 MG Oral TabletSCD6e7ca993-c8b9-4510-a2b0-5bcc678d25714

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69543-417-1069543041710100 TABLET in 1 BOTTLE (69543-417-10) 100 tablet2020-09-012027-07-31NoNoCurrent