Duloxetine

Product NDC
31722-168
Requested package NDC
31722-168-31
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204343-001DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-03
A204343-002DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-03
A204343-003DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A204343-001AB
A204343-002AB
A204343-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204343-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204343-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204343-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204343-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204343-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204343-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A204343-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204343-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204343-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204343-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204343-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204343-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204343-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204343-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204343-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204343-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204343-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204343-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204343-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204343-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204343-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204343-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204343-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204343-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204343-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204343-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204343-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204343-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A204343-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A204343-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204343-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204343-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204343-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204343-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204343-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204343-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204343-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204343-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204343-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204343-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-08-038072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204343-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204343-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204343-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204343-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204343-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204343-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204343-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204343-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204343-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204343-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204343-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204343-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204343-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204343-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204343-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204343-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204343-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204343-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204343-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204343-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204343-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204343-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204343-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204343-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204343-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204343-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204343-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204343-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204343-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204343-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204343-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204343-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204343-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204343-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204343-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204343-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204343-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204343-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204343-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204343-001AB18072bd15b7f6…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9044SC542WInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
596926Internal RxNorm lookup
596930Internal RxNorm lookup
596934Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b14feecc-04c6-4b2d-ba55-2e1dbef6b0d7Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DuloxetineDULOXETINECamber Pharmaceuticals, Inc.b14feecc-04c6-4b2d-ba55-2e1dbef6b0d72024-09-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204343
application number: ANDA204343
ndc (package): 31722-168-31
ndc (product): 31722-168
ndc11 (package): 31722016831

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
31722-168-31317220168317 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (31722-168-31) 2020-12-300000-00-00NoNoCurrent