Levorphanol Tartrate

Product NDC
63629-2093
11-digit product format
636292093
Labeler code
63629
Product ID
63629-2093_46b0156b-828d-4997-bc71-e4e5471b9883
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levorphanol Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA213479
Marketing category
ANDA
Marketing start
2019-05-20
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
63629-2093-1Levorphanol Tartrate100 in 1 BOTTLETABLET100106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2093-1EA - Each63629-2093a39af356-0226-494d-bd5c-e6b2ac9f040312021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2093LEVORPHANOL TARTRATE TABLET [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 1 package rows20240816_d7587868-561c-4e04-b02c-36a4b653a762.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197873levorphanol tartrate 2 MG Oral TabletPSNd7587868-561c-4e04-b02c-36a4b653a762106
197873levorphanol tartrate 2 MG Oral TabletSCDd7587868-561c-4e04-b02c-36a4b653a762106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2093-163629209301100 TABLET in 1 BOTTLE (63629-2093-1) 100 tablet2024-08-080000-00-00NoNoCurrent