DULOXETINE

Product NDC
48792-7895
11-digit product format
487927895
Labeler code
48792
Product ID
48792-7895_bbc151fd-32ab-5639-e053-2a95a90a3d0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine hydrochloride
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Sunshine Lake Pharma Co., Ltd.
Application
ANDA212328
Marketing category
ANDA
Marketing start
2021-02-11
Marketing end
0000-00-00
Substance
DULOXETINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct48792-7895DDiscontinued by firm2026-08-03
excluded packagepackage48792-789548792-7895-1DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage48792-7895-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage48792-7895-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage48792-7895-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage48792-7895-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage48792-7895-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage48792-7895-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage48792-7895-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage48792-7895-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage48792-7895-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage48792-7895-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage48792-7895-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage48792-7895-1557ba5c1ecfa…9c80585c8c6e…

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
A212328-001DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-11
A212328-002DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-11
A212328-003DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212328-001AB
A212328-002AB
A212328-003AB

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 3 · 102 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212328-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212328-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212328-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212328-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212328-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212328-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212328-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212328-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212328-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212328-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212328-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212328-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212328-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212328-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212328-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212328-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212328-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212328-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212328-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212328-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212328-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212328-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212328-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212328-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212328-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212328-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212328-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212328-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A212328-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A212328-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212328-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212328-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212328-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212328-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212328-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212328-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212328-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212328-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212328-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212328-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-02-118072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A212328-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212328-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212328-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212328-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212328-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212328-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212328-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212328-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212328-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212328-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212328-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212328-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212328-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212328-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212328-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212328-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212328-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212328-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212328-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212328-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212328-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212328-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212328-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212328-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212328-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212328-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212328-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212328-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212328-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212328-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212328-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212328-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212328-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212328-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212328-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212328-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212328-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212328-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212328-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212328-001AB18072bd15b7f6…

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
48792-7895-14879278950160 CAPSULE, DELAYED RELEASE in 1 BOTTLE (48792-7895-1) 2021-02-110000-00-00NoNoCurrent