Duloxetine

Product NDC: 67877-264
11-digit product format: 678770264
Labeler code: 67877
Product ID: 67877-264_958fae45-5e7a-4f8b-80b7-5934222747b5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Duloxetine
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Ascend Laboratories, LLC
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203197-001	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26
A203197-002	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26
A203197-003	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203197-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203197-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203197-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203197-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203197-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203197-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203197-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203197-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203197-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203197-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203197-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203197-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203197-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203197-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203197-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203197-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203197-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203197-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203197-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203197-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203197-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203197-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203197-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203197-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203197-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203197-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203197-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203197-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203197-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203197-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203197-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203197-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203197-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203197-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203197-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203197-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203197-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203197-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203197-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203197-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-26	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203197-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203197-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203197-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203197-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203197-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203197-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203197-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203197-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203197-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203197-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203197-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203197-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203197-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203197-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203197-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203197-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203197-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203197-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203197-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203197-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203197-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203197-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203197-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203197-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203197-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203197-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203197-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203197-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203197-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203197-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203197-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203197-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203197-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203197-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203197-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203197-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203197-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203197-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203197-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203197-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DULOXETINE HYDROCHLORIDE	30 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
596926	Internal RxNorm lookup
596930	Internal RxNorm lookup
596934	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
e6477c41-97a2-45a7-94b5-487aa65199f6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88	Product name	9	20210727
7dd29e28-6b69-499b-9257-12a3b46ca283	Product name	1	20191120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67877-264-01	Duloxetine	100 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	100	24
67877-264-10	Duloxetine	1000 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	1000	24
67877-264-30	Duloxetine	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	24
67877-264-90	Duloxetine	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67877-264-10	EA - Each	67877-264	07b8d468-112a-42ca-9ca4-0ca9726b37ae	1	2019-10-07
67877-264-30	EA - Each	67877-264	5a49d906-ea56-424d-b556-f287a1acb74e	1	2019-10-07
67877-264-90	EA - Each	67877-264	10869b85-5d41-4ccb-8d5d-6eeef6dfeb32	1	2019-10-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DULOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	9044SC542W	DULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]	8
DULOXETINE	ACTIVE MOIETY	O5TNM5N07U	DULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]	8
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]	8
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]	8
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	DULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]	8
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	DULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]	8
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]	8
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]	8
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]	8
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]	8
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	DULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]	8
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)	INACTIVE INGREDIENT	87Y6436BKR	DULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]	8
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]	8
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	DULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]	8
METHYLENE CHLORIDE	INACTIVE INGREDIENT	588X2YUY0A	DULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]	8
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	DULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]	8
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]	8
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]	8
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]	8
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]	8
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]	8
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	DULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67877-264	DULOXETINE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]	22	Current NDC, Legacy NDC, 4 package rows	20231130_e6477c41-97a2-45a7-94b5-487aa65199f6.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Duloxetine	DULOXETINE	Bryant Ranch Prepack	c52fc4ad-7bda-4824-8edf-117d3d8d6b3d	2025-09-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203197 application number: ANDA203197
Duloxetine	DULOXETINE	Ascend Laboratories, LLC	e6477c41-97a2-45a7-94b5-487aa65199f6	2025-08-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203197 application number: ANDA203197 ndc (product): 67877-264
Duloxetine HCL DR	DULOXETINE HCL	Advanced Rx of Tennessee, LLC	af6f8abd-19ec-69e4-e053-2a95a90ab69e	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203197 application number: ANDA203197
Duloxetine	DULOXETINE	Proficient Rx LP	d0a48dfd-af34-470b-9e1f-7678203e9ae5	2020-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203197 application number: ANDA203197

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9044SC542W	DULOXETINE HYDROCHLORIDE	136434-34-9	DULOXETINE HYDROCHLORIDE
O5TNM5N07U	DULOXETINE	116539-59-4	Duloxetine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
596926	DULoxetine 20 MG Delayed Release Oral Capsule	PSN	e6477c41-97a2-45a7-94b5-487aa65199f6	24
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	e6477c41-97a2-45a7-94b5-487aa65199f6	24
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	e6477c41-97a2-45a7-94b5-487aa65199f6	24
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	e6477c41-97a2-45a7-94b5-487aa65199f6	24
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	e6477c41-97a2-45a7-94b5-487aa65199f6	24
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	e6477c41-97a2-45a7-94b5-487aa65199f6	24
596926	duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	e6477c41-97a2-45a7-94b5-487aa65199f6	24
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	e6477c41-97a2-45a7-94b5-487aa65199f6	24
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	e6477c41-97a2-45a7-94b5-487aa65199f6	24
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	af6f8abd-19ec-69e4-e053-2a95a90ab69e	11
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	af6f8abd-19ec-69e4-e053-2a95a90ab69e	11
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	af6f8abd-19ec-69e4-e053-2a95a90ab69e	11
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	c52fc4ad-7bda-4824-8edf-117d3d8d6b3d	6
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	c52fc4ad-7bda-4824-8edf-117d3d8d6b3d	6
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	c52fc4ad-7bda-4824-8edf-117d3d8d6b3d	6
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	d0a48dfd-af34-470b-9e1f-7678203e9ae5	1
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	d0a48dfd-af34-470b-9e1f-7678203e9ae5	1
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	d0a48dfd-af34-470b-9e1f-7678203e9ae5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67877-264-01	67877026401	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-264-01)	2012-05-01	0000-00-00	No	No	Current
67877-264-10	67877026410	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-264-10)	2012-05-01	0000-00-00	No	No	Current
67877-264-30	67877026430	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-264-30)	2012-05-01	0000-00-00	No	No	Current
67877-264-90	67877026490	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-264-90)	2012-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Duloxetine	Bryant Ranch Prepack	2025-09-24	HUMAN PRESCRIPTION DRUG LABEL	6
Duloxetine	Ascend Laboratories, LLC \| Alkem Laboratories Limited	2025-08-11	Human Prescription Drug Label	24
Duloxetine HCL DR Capsule	Advanced Rx of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	11
Duloxetine	REMEDYREPACK INC.	2023-09-08	HUMAN PRESCRIPTION DRUG LABEL	4
Duloxetine	Preferred Pharmaceuticals Inc.	2022-05-10	HUMAN PRESCRIPTION DRUG LABEL	2
Duloxetine	Proficient Rx LP	2020-05-01	HUMAN PRESCRIPTION DRUG LABEL	1