Duloxetine

Product NDC
82804-024
11-digit product format
828040024
Labeler code
82804
Product ID
82804-024_f5e7503a-b28f-4cd0-a4ee-47bdca88d54b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DULOXETINE HYDROCHLORIDE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA203088
Marketing category
ANDA
Marketing start
2018-05-21
Substance
DULOXETINE HYDROCHLORIDE
Active strength
40 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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203088-001DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2014-06-11
A203088-002DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2014-06-11
A203088-003DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2014-06-11
A203088-004DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-05-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A203088-001AB
A203088-002AB
A203088-003AB
A203088-004AB

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A203088-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2014-06-1184e616aacf4f…
2026-09-14 22:38:342026-08A203088-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2014-06-1184e616aacf4f…
2026-09-14 22:38:342026-08A203088-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2014-06-1184e616aacf4f…
2026-09-14 22:38:342026-08A203088-004DULOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-05-1884e616aacf4f…
2026-08-18 06:07:402026-07A203088-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2014-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07A203088-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2014-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07A203088-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2014-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07A203088-004DULOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-05-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203088-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2014-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203088-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2014-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203088-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2014-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203088-004DULOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-05-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203088-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2014-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203088-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2014-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203088-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2014-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203088-004DULOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-05-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A203088-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2014-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203088-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2014-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203088-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2014-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203088-004DULOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-05-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203088-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2014-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203088-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2014-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203088-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2014-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203088-004DULOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-05-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203088-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2014-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203088-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2014-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203088-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2014-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203088-004DULOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-05-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203088-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2014-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203088-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2014-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203088-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2014-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203088-004DULOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-05-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203088-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2014-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203088-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2014-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203088-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2014-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203088-004DULOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-05-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203088-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2014-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203088-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2014-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203088-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2014-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203088-004DULOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-05-185bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A203088-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A203088-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A203088-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A203088-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A203088-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203088-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203088-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203088-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203088-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203088-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203088-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203088-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203088-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203088-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203088-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203088-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203088-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203088-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203088-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203088-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203088-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203088-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203088-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203088-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203088-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203088-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203088-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203088-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203088-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203088-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203088-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203088-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203088-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203088-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203088-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203088-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203088-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203088-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203088-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203088-004AB15bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Duloxetine
Brand name suffix
Delayed-Release
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DULOXETINE HYDROCHLORIDE40 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
616402Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f5e7503a-b28f-4cd0-a4ee-47bdca88d54bAvailable 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
82804-024-30DuloxetineDelayed-Release30 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS301
82804-024-60DuloxetineDelayed-Release60 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS601
82804-024-90DuloxetineDelayed-Release90 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-024-30EA - Each82804-0245b79153a-5535-4a57-919c-aba151a656a312023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-024DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [PROFICIENT RX LP]1Current NDC, 3 package rows20231027_f5e7503a-b28f-4cd0-a4ee-47bdca88d54b.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 2 of 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepack675f999d-46b2-45da-b17e-58cc2ba180b12024-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203088
application number: ANDA203088
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCb1f1345c-3b7f-4228-b7b7-b9a4648050e52024-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203088
application number: ANDA203088
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBluePoint Laboratoriesa95cc04c-58e9-487f-8992-ef30df03a3cd2024-02-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203088
application number: ANDA203088
DULOXETINE DELAYED-RELEASEDULOXETINE HYDROCHLORIDEProficient Rx LP41c86c02-68c0-4db5-af1a-941b0d2ffe112024-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203088
application number: ANDA203088
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEProficient Rx LPf5e7503a-b28f-4cd0-a4ee-47bdca88d54b2023-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203088
application number: ANDA203088
ndc (product): 82804-024
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCdcfd62c7-1687-4e9b-9ae4-5a44929ac7652023-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203088
application number: ANDA203088
DULOXETINE DELAYED-RELEASEDULOXETINE HYDROCHLORIDEProficient Rx LP22a8cc15-17fb-4c4e-8d2a-de5755ed60312022-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203088
application number: ANDA203088
DULOXETINE DELAYED-RELEASEDULOXETINE HYDROCHLORIDEProficient Rx LP407b62b9-5b32-4bac-a2b0-7df4992792482019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203088
application number: ANDA203088
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCdb686a0a-9b2a-4017-8bd1-b981da47c2f32019-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203088
application number: ANDA203088

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616402DULoxetine 40 MG Delayed Release Oral CapsulePSNf5e7503a-b28f-4cd0-a4ee-47bdca88d54b1
616402duloxetine 40 MG Delayed Release Oral CapsuleSCDf5e7503a-b28f-4cd0-a4ee-47bdca88d54b1
616402duloxetine 40 MG (as duloxetine HCl 44.9 MG) Delayed Release Oral CapsuleSYf5e7503a-b28f-4cd0-a4ee-47bdca88d54b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82804-024-308280400243030 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82804-024-30) 2023-10-16NoNoCurrent
82804-024-608280400246060 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82804-024-60) 2023-10-16NoNoCurrent
82804-024-908280400249090 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82804-024-90) 2023-10-16NoNoCurrent