LEVORPHANOL TARTRATE

Product NDC
0054-0438
11-digit product format
000540438
Labeler code
0054
Product ID
0054-0438_0bfc1a93-9279-415f-8510-9eaa522c0a5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVORPHANOL TARTRATE
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA074278
Marketing category
ANDA
Marketing start
2000-03-31
Substance
LEVORPHANOL TARTRATE
Active strength
2 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0054-0438-25LEVORPHANOL TARTRATE100 in 1 BOTTLE, PLASTICTABLET10017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0438-25EA - Each0054-04380f48e528-c87a-4d02-b4f2-1916346943e912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVORPHANOL TARTRATEACTIVE INGREDIENT04WQU6T9QILEVORPHANOL TARTRATE TABLET [ROXANE LABORATORIES, INC]7
LEVORPHANOLACTIVE MOIETY27618J1N2XLEVORPHANOL TARTRATE TABLET [ROXANE LABORATORIES, INC]7
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLEVORPHANOL TARTRATE TABLET [ROXANE LABORATORIES, INC]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVORPHANOL TARTRATE TABLET [ROXANE LABORATORIES, INC]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLEVORPHANOL TARTRATE TABLET [ROXANE LABORATORIES, INC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-0438LEVORPHANOL TARTRATE TABLET [HIKMA PHARMACEUTICALS USA INC.]14Current NDC, 1 package rows20240202_b2ab70e4-ca0c-4a73-9c98-974bf94e890c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197873levorphanol tartrate 2 MG Oral TabletPSNb2ab70e4-ca0c-4a73-9c98-974bf94e890c17
197873levorphanol tartrate 2 MG Oral TabletSCDb2ab70e4-ca0c-4a73-9c98-974bf94e890c17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0054-0438-2500054043825100 TABLET in 1 BOTTLE, PLASTIC (0054-0438-25) 100 tablet2023-02-02NoNoHistorical