Levorphanol Tartrate

Product NDC
0527-3237
11-digit product format
005273237
Labeler code
0527
Product ID
0527-3237_a0edf042-6bef-434f-bd7e-ca4a899c1841
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levorphanol Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA213479
Marketing category
ANDA
Marketing start
2020-01-12
Substance
LEVORPHANOL TARTRATE
Active strength
3 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 TARTRATE3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04WQU6T9QI
Rxcui197873, 2058845

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
0527-3237-37Levorphanol Tartrate100 in 1 BOTTLETABLET1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-3237-37EA - Each0527-3237b64e24c9-977f-48a2-b9ee-ac8df91899c212021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-3237LEVORPHANOL TARTRATE TABLET [LANNETT COMPANY, INC.]6Current NDC, Legacy NDC, 1 package rows20240615_a50debe1-90b3-4931-9ec0-67e88dd21b04.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197873levorphanol tartrate 2 MG Oral TabletPSNa50debe1-90b3-4931-9ec0-67e88dd21b047
2058845levorphanol tartrate 3 MG Oral TabletPSNa50debe1-90b3-4931-9ec0-67e88dd21b047
197873levorphanol tartrate 2 MG Oral TabletSCDa50debe1-90b3-4931-9ec0-67e88dd21b047
2058845levorphanol tartrate 3 MG Oral TabletSCDa50debe1-90b3-4931-9ec0-67e88dd21b047

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-3237-3700527323737100 TABLET in 1 BOTTLE (0527-3237-37) 100 tablet2021-01-120000-00-00NoNoCurrent