FDA.reportPublic FDA data

duloxetine

Product NDC
70247-012
11-digit product format
702470012
Labeler code
70247
Product ID
70247-012_435c56f7-5995-3906-e063-6394a90af073
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Qingdao BAHEAL Pharmaceutical Co., Ltd.
Application
ANDA210599
Marketing category
ANDA
Marketing start
2018-05-05
Substance
DULOXETINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DULOXETINE HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9044SC542W
Rxcui596926, 596930, 596934

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88Product name920210727
7dd29e28-6b69-499b-9257-12a3b46ca283Product name120191120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70247-012-06duloxetine60 in 1 BOTTLECAPSULE, DELAYED RELEASE6010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70247-012NA (DULOXETINE DELAYED-RELEASE CAPSULES) CAPSULE, DELAYED RELEASE [QINGDAO BAHEAL PHARMACEUTICAL CO., LTD.]9Current NDC, Legacy NDC, 1 package rows20241222_e428429e-e1ea-40e1-870f-134533dc3aa1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSNe428429e-e1ea-40e1-870f-134533dc3aa110
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNe428429e-e1ea-40e1-870f-134533dc3aa110
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNe428429e-e1ea-40e1-870f-134533dc3aa110
596926duloxetine 20 MG Delayed Release Oral CapsuleSCDe428429e-e1ea-40e1-870f-134533dc3aa110
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDe428429e-e1ea-40e1-870f-134533dc3aa110
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDe428429e-e1ea-40e1-870f-134533dc3aa110
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSYe428429e-e1ea-40e1-870f-134533dc3aa110
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYe428429e-e1ea-40e1-870f-134533dc3aa110
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYe428429e-e1ea-40e1-870f-134533dc3aa110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70247-012-067024700120660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70247-012-06) 2018-05-080000-00-00NoNoCurrent