FDA.reportPublic FDA data

Duloxetine

Product NDC
31722-168
11-digit product format
317220168
Labeler code
31722
Product ID
31722-168_232a4dda-8bb0-52fa-e063-6394a90ab09e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA204343
Marketing category
ANDA
Marketing start
2020-12-30
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
31722-168-01Duloxetine100 in 1 BOTTLECAPSULE, DELAYED RELEASE1003
31722-168-05Duloxetine500 in 1 BOTTLECAPSULE, DELAYED RELEASE5003
31722-168-10Duloxetine1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10003
31722-168-30Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE303
31722-168-31Duloxetine7 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE73
31722-168-32Duloxetine105 in 1 CARTONCAPSULE, DELAYED RELEASE1053
31722-168-60Duloxetine60 in 1 BOTTLECAPSULE, DELAYED RELEASE603
31722-168-90Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-168-60EA - Each31722-16871a05f82-dc68-467b-bfe9-8c2166445ec712022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-168DULOXETINE (DULOXETINE) CAPSULE, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 8 package rows20240929_b14feecc-04c6-4b2d-ba55-2e1dbef6b0d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSNb14feecc-04c6-4b2d-ba55-2e1dbef6b0d73
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNb14feecc-04c6-4b2d-ba55-2e1dbef6b0d73
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNb14feecc-04c6-4b2d-ba55-2e1dbef6b0d73
596926duloxetine 20 MG Delayed Release Oral CapsuleSCDb14feecc-04c6-4b2d-ba55-2e1dbef6b0d73
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDb14feecc-04c6-4b2d-ba55-2e1dbef6b0d73
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDb14feecc-04c6-4b2d-ba55-2e1dbef6b0d73
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSYb14feecc-04c6-4b2d-ba55-2e1dbef6b0d73
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYb14feecc-04c6-4b2d-ba55-2e1dbef6b0d73
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYb14feecc-04c6-4b2d-ba55-2e1dbef6b0d73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-168-0131722016801100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-168-01) 2020-12-300000-00-00NoNoCurrent
31722-168-0531722016805500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-168-05) 2024-06-29NoNoCurrent
31722-168-10317220168101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-168-10) 2020-12-300000-00-00NoNoCurrent
31722-168-303172201683030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-168-30) 2020-12-300000-00-00NoNoCurrent
31722-168-31317220168317 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (31722-168-31) 2020-12-300000-00-00NoNoCurrent
31722-168-3231722016832105 CAPSULE, DELAYED RELEASE in 1 CARTON (31722-168-32) 2020-12-300000-00-00NoNoCurrent
31722-168-603172201686060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-168-60) 2020-12-300000-00-00NoNoCurrent
31722-168-903172201689090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-168-90) 2024-06-29NoNoCurrent