Levorphanol Tartrate

Product NDC
0406-2224
11-digit product format
004062224
Labeler code
0406
Product ID
0406-2224_72cc6b5a-55a3-405c-bf1d-c8810077aa21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levorphanol Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
SpecGx LLC
Application
ANDA212024
Marketing category
ANDA
Marketing start
2019-12-13
Substance
LEVORPHANOL TARTRATE
Active strength
2 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levorphanol Tartrate
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0406-2224-01Levorphanol Tartrate100 in 1 BOTTLE, PLASTICTABLET10018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-2224-01EA - Each0406-22249294750f-f242-4d56-b7e2-c8aa82e0bf6512020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0406-2224LEVORPHANOL TARTRATE TABLET [SPECGX LLC]15Current NDC, Legacy NDC, 1 package rows20240815_759c7040-0be0-4d17-be97-e467e423eaa8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197873levorphanol tartrate 2 MG Oral TabletPSN759c7040-0be0-4d17-be97-e467e423eaa818
197873levorphanol tartrate 2 MG Oral TabletSCD759c7040-0be0-4d17-be97-e467e423eaa818

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0406-2224-0100406222401100 TABLET in 1 BOTTLE, PLASTIC (0406-2224-01) 100 tablet2019-12-130000-00-00NoNoCurrent