Home NDC 52427-791 Duloxetine
Product NDC 52427-791
11-digit product format 524270791
Labeler code 52427
Product ID 52427-791_928a297f-2836-28d7-c820-ece5656c6b57
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Duloxetine
Dosage form CAPSULE, DELAYED RELEASE
Route ORAL
Labeler Almatica Pharma LLC
Application NDA219131
Marketing category NDA
Marketing start 2026-07-01
Substance DULOXETINE HYDROCHLORIDE
Active strength 120 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N219131-001 DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE, DELAYED REL PELLETS / ORAL RLD, RS 2026-02-27 N219131-002 DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE EQ 90MG BASE CAPSULE, DELAYED REL PELLETS / ORAL RLD 2026-02-27 N219131-003 DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE EQ 120MG BASE CAPSULE, DELAYED REL PELLETS / ORAL RLD 2026-02-27
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N219131-001 12721817 2046-01-13 Drug product 2026-09-01 N219131-002 12721817 2046-01-13 Drug product 2026-09-01 N219131-003 12721817 2046-01-13 Drug product 2026-09-01
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.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N219131-001 DULOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE, DELAYED REL PELLETS / ORAL RLD, RS 2026-02-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219131-002 DULOXETINE HYDROCHLORIDE EQ 90MG BASE CAPSULE, DELAYED REL PELLETS / ORAL RLD 2026-02-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219131-003 DULOXETINE HYDROCHLORIDE EQ 120MG BASE CAPSULE, DELAYED REL PELLETS / ORAL RLD 2026-02-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219131-001 DULOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE, DELAYED REL PELLETS / ORAL RLD, RS 2026-02-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219131-002 DULOXETINE HYDROCHLORIDE EQ 90MG BASE CAPSULE, DELAYED REL PELLETS / ORAL RLD 2026-02-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219131-003 DULOXETINE HYDROCHLORIDE EQ 120MG BASE CAPSULE, DELAYED REL PELLETS / ORAL RLD 2026-02-27 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219131-001 DULOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE, DELAYED REL PELLETS / ORAL RLD, RS 2026-02-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219131-002 DULOXETINE HYDROCHLORIDE EQ 90MG BASE CAPSULE, DELAYED REL PELLETS / ORAL RLD 2026-02-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219131-003 DULOXETINE HYDROCHLORIDE EQ 120MG BASE CAPSULE, DELAYED REL PELLETS / ORAL RLD 2026-02-27 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N219131-001 12721817 2046-01-13 Drug product 2026-09-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219131-002 12721817 2046-01-13 Drug product 2026-09-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219131-003 12721817 2046-01-13 Drug product 2026-09-01 84e616aacf4f…
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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DULOXETINE HYDROCHLORIDE 120 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9044SC542W Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2745865 Internal RxNorm lookup 2745867 Internal RxNorm lookup 2745869 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 52427-791-30 52427079130 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (52427-791-30) 2026-07-01 No No Current