Levorphanol Tartrate

Product NDC
57664-762
11-digit product format
576640762
Labeler code
57664
Product ID
57664-762_48471dc2-bdd9-2263-e063-6294a90a9e03
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levorphanol Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA213906
Marketing category
ANDA
Marketing start
2022-04-26
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, 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
57664-762-88Levorphanol Tartrate100 in 1 BOTTLETABLET10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-762-88EA - Each57664-76290788347-3f39-4816-8fce-0c95ba60ce4e12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-762LEVORPHANOL TARTRATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]9Current NDC, Legacy NDC, 1 package rows20240831_438cf3ea-04fe-4626-9f0f-adcda7633651.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197873levorphanol tartrate 2 MG Oral TabletPSN438cf3ea-04fe-4626-9f0f-adcda763365110
2058845levorphanol tartrate 3 MG Oral TabletPSN438cf3ea-04fe-4626-9f0f-adcda763365110
197873levorphanol tartrate 2 MG Oral TabletSCD438cf3ea-04fe-4626-9f0f-adcda763365110
2058845levorphanol tartrate 3 MG Oral TabletSCD438cf3ea-04fe-4626-9f0f-adcda763365110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57664-762-8857664076288100 TABLET in 1 BOTTLE (57664-762-88) 100 tablet2022-04-260000-00-00NoNoCurrent