Levorphanol Tartrate

Product NDC
72989-417
11-digit product format
729890417
Labeler code
72989
Product ID
72989-417_13e399bd-0f7e-46d8-89fe-cc2c5854f3c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levorphanol Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
ACERTIS PHARMACEUTICALS, LLC
Application
ANDA211484
Marketing category
ANDA
Marketing start
2025-07-14
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levorphanol Tartrate
Listing expiration
2026-12-31

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
72989-417-10Levorphanol Tartrate100 in 1 BOTTLETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72989-417-10EA - Each72989-417234bc8c9-d85d-4c7c-aedd-a25b3cd9ee3e12025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197873levorphanol tartrate 2 MG Oral TabletPSN113a713f-830b-481c-bfa6-d44e3ac27f801
197873levorphanol tartrate 2 MG Oral TabletSCD113a713f-830b-481c-bfa6-d44e3ac27f801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72989-417-1072989041710100 TABLET in 1 BOTTLE (72989-417-10) 100 tablet2025-07-14NoNoCurrent