DULOXETINE

Product NDC
43547-381
11-digit product format
435470381
Labeler code
43547
Product ID
43547-381_1b037cb5-9db9-44a6-89dd-1cf1dcf895fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Solco Healthcare US, LLC
Application
ANDA206653
Marketing category
ANDA
Marketing start
2016-01-20
Substance
DULOXETINE HYDROCHLORIDE
Active strength
60 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
A206653-001DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-18
A206653-002DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-18
A206653-003DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206653-001AB
A206653-002AB
A206653-003AB

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 UTC2026-02A206653-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206653-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206653-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206653-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206653-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206653-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A206653-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206653-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206653-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206653-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206653-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206653-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206653-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206653-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206653-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206653-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206653-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206653-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206653-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206653-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206653-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206653-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206653-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206653-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206653-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206653-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206653-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206653-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A206653-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A206653-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206653-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206653-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206653-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206653-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206653-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206653-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206653-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206653-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206653-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206653-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-05-188072bd15b7f6…

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 UTC2026-02A206653-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206653-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206653-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206653-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206653-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206653-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206653-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206653-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206653-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206653-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206653-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206653-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206653-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206653-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206653-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206653-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206653-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206653-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206653-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206653-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206653-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206653-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206653-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206653-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206653-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206653-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206653-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206653-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206653-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206653-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206653-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206653-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206653-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206653-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206653-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206653-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206653-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206653-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206653-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206653-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DULOXETINE HYDROCHLORIDE60 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
a105a648-6a97-4151-b9de-d7eac90a8f79Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88Product name920210727
7dd29e28-6b69-499b-9257-12a3b46ca283Product name120191120
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43547-381-03DULOXETINE30 in 1 BOTTLECAPSULE, DELAYED RELEASE3010
43547-381-09DULOXETINE90 in 1 BOTTLECAPSULE, DELAYED RELEASE9010
43547-381-11DULOXETINE1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-381-03EA - Each43547-381ed272d4e-5319-433c-a38b-c78267b0345e12017-09-11
43547-381-09EA - Each43547-38198e7ab8d-386b-45a0-a33b-0c74449576af12017-09-11
43547-381-11EA - Each43547-38140921d57-1763-4b96-8349-e4eb7ff41b1012017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-381DULOXETINE CAPSULE, DELAYED RELEASE [SOLCO HEALTHCARE US, LLC]10Current NDC, Legacy NDC, 3 package rows20230715_a105a648-6a97-4151-b9de-d7eac90a8f79.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DULOXETINEDULOXETINEBryant Ranch Prepack9a8cb289-0332-4835-960f-32d273092d152024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206653
application number: ANDA206653
DULOXETINEDULOXETINESolco Healthcare US, LLCa105a648-6a97-4151-b9de-d7eac90a8f792023-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206653
application number: ANDA206653
ndc (product): 43547-381

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596926DULoxetine 20 MG Delayed Release Oral CapsulePSNa105a648-6a97-4151-b9de-d7eac90a8f7910
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNa105a648-6a97-4151-b9de-d7eac90a8f7910
596934DULoxetine 60 MG Delayed Release Oral CapsulePSNa105a648-6a97-4151-b9de-d7eac90a8f7910
596926duloxetine 20 MG Delayed Release Oral CapsuleSCDa105a648-6a97-4151-b9de-d7eac90a8f7910
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDa105a648-6a97-4151-b9de-d7eac90a8f7910
596934duloxetine 60 MG Delayed Release Oral CapsuleSCDa105a648-6a97-4151-b9de-d7eac90a8f7910
596926duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral CapsuleSYa105a648-6a97-4151-b9de-d7eac90a8f7910
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYa105a648-6a97-4151-b9de-d7eac90a8f7910
596934duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral CapsuleSYa105a648-6a97-4151-b9de-d7eac90a8f7910

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43547-381-034354703810330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-381-03) 2016-01-200000-00-00NoNoCurrent
43547-381-094354703810990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-381-09) 2016-01-200000-00-00NoNoCurrent
43547-381-11435470381111000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-381-11) 2016-01-200000-00-00NoNoCurrent