Duloxetine

Product NDC
71335-1672
11-digit product format
713351672
Labeler code
71335
Product ID
71335-1672_a5fa1183-35f7-41b9-8452-5d00ccd868a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203197
Marketing category
ANDA
Marketing start
2012-05-01
Substance
DULOXETINE HYDROCHLORIDE
Active strength
30 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
A203197-001DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-26
A203197-002DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-26
A203197-003DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203197-001AB
A203197-002AB
A203197-003AB

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 UTC2026-02A203197-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203197-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203197-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203197-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203197-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203197-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A203197-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203197-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203197-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203197-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203197-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203197-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203197-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203197-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203197-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203197-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203197-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203197-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203197-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203197-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203197-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203197-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203197-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203197-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203197-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203197-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203197-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203197-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A203197-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A203197-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203197-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203197-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203197-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203197-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203197-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203197-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203197-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203197-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203197-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203197-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-08-268072bd15b7f6…

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 UTC2026-02A203197-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203197-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203197-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203197-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203197-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203197-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203197-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203197-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203197-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203197-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203197-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203197-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203197-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203197-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203197-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203197-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203197-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203197-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203197-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203197-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203197-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203197-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203197-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203197-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203197-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203197-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203197-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203197-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203197-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203197-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203197-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203197-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203197-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203197-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203197-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203197-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203197-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203197-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203197-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203197-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DULOXETINE HYDROCHLORIDE30 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
596930Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c52fc4ad-7bda-4824-8edf-117d3d8d6b3dAvailable 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
71335-1672-1Duloxetine30 in 1 BOTTLECAPSULE, DELAYED RELEASE306
71335-1672-2Duloxetine60 in 1 BOTTLECAPSULE, DELAYED RELEASE606
71335-1672-3Duloxetine28 in 1 BOTTLECAPSULE, DELAYED RELEASE286
71335-1672-4Duloxetine6 in 1 BOTTLECAPSULE, DELAYED RELEASE66
71335-1672-5Duloxetine90 in 1 BOTTLECAPSULE, DELAYED RELEASE906
71335-1672-6Duloxetine15 in 1 BOTTLECAPSULE, DELAYED RELEASE156
71335-1672-7Duloxetine180 in 1 BOTTLECAPSULE, DELAYED RELEASE1806
71335-1672-8Duloxetine120 in 1 BOTTLECAPSULE, DELAYED RELEASE1206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1672-1EA - Each71335-1672c74b3b85-e5d8-4064-ad3e-2d16cfc4424f12021-02-05
71335-1672-2EA - Each71335-167267a083f5-1d6f-4e2d-8d39-06df451214f012021-02-05
71335-1672-5EA - Each71335-16721764c6dc-dc4b-40fb-b80c-6dd1a4df1d8312021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1672DULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 8 package rows20240410_c52fc4ad-7bda-4824-8edf-117d3d8d6b3d.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DuloxetineDULOXETINEBryant Ranch Prepackc52fc4ad-7bda-4824-8edf-117d3d8d6b3d2025-09-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203197
application number: ANDA203197
ndc (product): 71335-1672
DuloxetineDULOXETINEAscend Laboratories, LLCe6477c41-97a2-45a7-94b5-487aa65199f62025-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203197
application number: ANDA203197
Duloxetine HCL DRDULOXETINE HCLAdvanced Rx of Tennessee, LLCaf6f8abd-19ec-69e4-e053-2a95a90ab69e2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203197
application number: ANDA203197
DuloxetineDULOXETINEProficient Rx LPd0a48dfd-af34-470b-9e1f-7678203e9ae52020-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203197
application number: ANDA203197

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596930DULoxetine 30 MG Delayed Release Oral CapsulePSNc52fc4ad-7bda-4824-8edf-117d3d8d6b3d6
596930duloxetine 30 MG Delayed Release Oral CapsuleSCDc52fc4ad-7bda-4824-8edf-117d3d8d6b3d6
596930duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral CapsuleSYc52fc4ad-7bda-4824-8edf-117d3d8d6b3d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1672-17133516720130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1672-1) 2020-07-270000-00-00NoNoCurrent
71335-1672-27133516720260 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1672-2) 2020-08-280000-00-00NoNoCurrent
71335-1672-37133516720328 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1672-3) 2024-04-040000-00-00NoNoCurrent
71335-1672-4713351672046 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1672-4) 2024-04-040000-00-00NoNoCurrent
71335-1672-57133516720590 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1672-5) 2020-12-220000-00-00NoNoCurrent
71335-1672-67133516720615 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1672-6) 2021-01-070000-00-00NoNoCurrent
71335-1672-771335167207180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1672-7) 2021-02-010000-00-00NoNoCurrent
71335-1672-871335167208120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1672-8) 2024-04-040000-00-00NoNoCurrent