Duloxetine Hydrochloride

Product NDC
63187-181
11-digit product format
631870181
Labeler code
63187
Product ID
63187-181_58a38000-a494-41ed-9491-a39e589f59b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine Hydrochloride
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA202045
Marketing category
ANDA
Marketing start
2014-06-13
Marketing end
0000-00-00
Substance
DULOXETINE HYDROCHLORIDE
Active strength
60 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
2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63187-181DDiscontinued by firm2026-08-11
excluded packagepackage63187-18163187-181-30DDiscontinued by firm2026-08-11
excluded packagepackage63187-18163187-181-60DDiscontinued by firm2026-08-11

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 · 6 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 packagepackage63187-181-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-181-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-181-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-181-60f5e01cc5f278…a2eaf40c39c3…

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
A202045-001DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-11
A202045-002DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-11
A202045-003DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-11

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 UTC2026-02A202045-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202045-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202045-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202045-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202045-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202045-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202045-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202045-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202045-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202045-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202045-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202045-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202045-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202045-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202045-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202045-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202045-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202045-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202045-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202045-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202045-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202045-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202045-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202045-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202045-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202045-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202045-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202045-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A202045-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A202045-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202045-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202045-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202045-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202045-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202045-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202045-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202045-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202045-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202045-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202045-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2014-06-118072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 69 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202045-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202045-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202045-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202045-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202045-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202045-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202045-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202045-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202045-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202045-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202045-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202045-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202045-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202045-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202045-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202045-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202045-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202045-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202045-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202045-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202045-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A202045-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A202045-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A202045-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202045-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A202045-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A202045-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202045-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A202045-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A202045-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202045-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A202045-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A202045-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A202045-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A202045-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A202045-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202045-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A202045-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A202045-003AB1ea99ee380514…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202045-001AB1a72a2bbeb626…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-181-30EA - Each63187-18183104a3d-d18a-4d51-84eb-cc59f3a5288b12015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]2
DULOXETINEACTIVE MOIETYO5TNM5N07UDULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XDULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]2
DIBUTYL SEBACATEINACTIVE INGREDIENT4W5IH7FLNYDULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]2
GELATININACTIVE INGREDIENT2G86QN327LDULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]2
METHYLCELLULOSE (15 MPA.S)INACTIVE INGREDIENTNPU9M2E6L8DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]2
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]2
POLYVINYL ACETATE PHTHALATEINACTIVE INGREDIENT58QVG85GW3DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TDULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EDULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]2
PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE)INACTIVE INGREDIENT9Q5W5G6461DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]2
SHELLACINACTIVE INGREDIENT46N107B71ODULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]2
TALCINACTIVE INGREDIENT7SEV7J4R1UDULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-181DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]4Legacy NDC20191121_b3c1561b-dd87-4338-a09f-ff4be5800cee.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-181-306318701813030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-181-30) 2018-12-010000-00-00NoNoCurrent
63187-181-606318701816060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-181-60) 2018-12-010000-00-00NoNoCurrent