Duloxetine

Product NDC: 68180-296
11-digit product format: 681800296
Labeler code: 68180
Product ID: 68180-296_7efa28f3-0b15-4e1c-835f-2f1dff37bee8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Duloxetine
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA090694
Marketing category: ANDA
Marketing start: 2013-12-11
Substance: DULOXETINE HYDROCHLORIDE
Active strength: 60 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090694-001	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11
A090694-002	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11
A090694-003	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11
A090694-004	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A090694-001	AB
A090694-002	AB
A090694-003	AB
A090694-004	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 5 · 164 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	A090694-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090694-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090694-003	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090694-004	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090694-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090694-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090694-003	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090694-004	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090694-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090694-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090694-003	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090694-004	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090694-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090694-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090694-003	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090694-004	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090694-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090694-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090694-003	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090694-004	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090694-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090694-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090694-003	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090694-004	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090694-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090694-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090694-003	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090694-004	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090694-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090694-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090694-003	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090694-004	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090694-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090694-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090694-003	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090694-004	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090694-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090694-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090694-003	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090694-004	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A090694-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090694-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090694-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090694-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090694-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090694-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090694-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090694-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090694-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090694-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090694-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090694-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090694-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090694-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090694-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090694-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090694-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090694-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090694-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090694-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090694-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090694-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090694-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090694-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090694-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090694-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090694-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090694-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090694-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090694-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090694-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090694-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090694-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090694-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090694-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090694-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090694-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090694-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090694-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090694-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Duloxetine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DULOXETINE HYDROCHLORIDE	60 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
596926	Internal RxNorm lookup
596930	Internal RxNorm lookup
596934	Internal RxNorm lookup
616402	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
829a4f51-c882-4b64-81f3-abfb03a52ebe	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
68180-296-03	Duloxetine	1000 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	1000	25
68180-296-06	Duloxetine	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	25
68180-296-09	Duloxetine	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-296-03	EA - Each	68180-296	b060f109-38d7-4554-b63b-fb7ce4d07383	1	2014-01-04
68180-296-06	EA - Each	68180-296	cad1816b-4a32-4d85-a69d-e258d8a52f6b	1	2014-01-04
68180-296-09	EA - Each	68180-296	dcfe392a-e6f8-43b9-9fd7-de01bb03d9dc	1	2014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DULOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	9044SC542W	DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	13
DULOXETINE	ACTIVE MOIETY	O5TNM5N07U	DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	13
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	13
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	13
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	13
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	13
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	13
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	13
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)	INACTIVE INGREDIENT	G4U024CQK6	DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	13
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	13
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	13
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	13
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	13
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	13
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	13
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	13
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	13
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	13
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	13
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	13
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	13
DULOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	9044SC542W	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
DULOXETINE	ACTIVE MOIETY	O5TNM5N07U	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)	INACTIVE INGREDIENT	G4U024CQK6	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68180-296	DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	24	Current NDC, Legacy NDC, 3 package rows	20250124_829a4f51-c882-4b64-81f3-abfb03a52ebe.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 2 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Duloxetine	DULOXETINE	REMEDYREPACK INC.	461d769c-b787-4bc7-b4a6-7a5f33ae9d45	2026-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	Bryant Ranch Prepack	79e1a9b1-e084-48b6-a252-97bbd2f55a79	2026-08-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	Golden State Medical Supply, Inc.	569582d5-cb6d-735e-e063-6394a90abfb6	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	REMEDYREPACK INC.	c66fb2ee-f64a-4d28-a692-e8dc7b61fbc9	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	REMEDYREPACK INC.	1d3a45f3-3854-4d0c-9241-770aa24063fd	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	Lupin Pharmaceuticals, Inc.	829a4f51-c882-4b64-81f3-abfb03a52ebe	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694 ndc (product): 68180-296
Duloxetine	DULOXETINE	Bryant Ranch Prepack	c877bb68-759f-4d45-8bef-872554da4551	2026-05-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	QPharma, Inc.	4f205401-39ac-7009-e063-6394a90aaa8c	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	Preferred Pharmaceuticals Inc.	9141b9d3-8d4d-43ec-acf9-e1b620590c4b	2026-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	A-S Medication Solutions	3424a326-9543-44f7-b31c-f84e12509238	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	A-S Medication Solutions	cdd870a9-3bed-42fc-b175-48aed5321969	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	Preferred Pharmaceuticals Inc.	ae381859-be09-43e1-8b56-d0d8f4b49020	2026-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	Coupler LLC	3edce3bd-1102-5951-e063-6394a90ae6c5	2026-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	Coupler LLC	3f649b01-0969-cc71-e063-6394a90a9df5	2026-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	A-S Medication Solutions	e2352870-3582-4d92-8712-87ad8bdccb87	2025-11-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	A-S Medication Solutions	e0381ead-d8bc-43fa-9f12-e0fefcaf7f3d	2025-11-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	Aphena Pharma Solutions - Tennessee, LLC	41c54fb7-03f8-2326-e063-6394a90a6352	2025-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine D/R	DULOXETINE D/R	Direct_Rx	3ac53025-8a99-31de-e063-6294a90a53d2	2025-07-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	Bryant Ranch Prepack	5584c5ed-cab6-4c8b-8307-41e5d77704d0	2025-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694
Duloxetine	DULOXETINE	Bryant Ranch Prepack	be0261c7-fb5e-4ba6-b7fb-13a1fecb5f75	2025-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090694 application number: ANDA090694

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	829a4f51-c882-4b64-81f3-abfb03a52ebe	25
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	829a4f51-c882-4b64-81f3-abfb03a52ebe	25
616402	DULoxetine 40 MG Delayed Release Oral Capsule	PSN	829a4f51-c882-4b64-81f3-abfb03a52ebe	25
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	829a4f51-c882-4b64-81f3-abfb03a52ebe	25
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	829a4f51-c882-4b64-81f3-abfb03a52ebe	25
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	829a4f51-c882-4b64-81f3-abfb03a52ebe	25
616402	duloxetine 40 MG Delayed Release Oral Capsule	SCD	829a4f51-c882-4b64-81f3-abfb03a52ebe	25
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	829a4f51-c882-4b64-81f3-abfb03a52ebe	25
596926	duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	829a4f51-c882-4b64-81f3-abfb03a52ebe	25
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	829a4f51-c882-4b64-81f3-abfb03a52ebe	25
616402	duloxetine 40 MG (as duloxetine HCl 44.9 MG) Delayed Release Oral Capsule	SY	829a4f51-c882-4b64-81f3-abfb03a52ebe	25
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	829a4f51-c882-4b64-81f3-abfb03a52ebe	25
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	461d769c-b787-4bc7-b4a6-7a5f33ae9d45	14
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	461d769c-b787-4bc7-b4a6-7a5f33ae9d45	14
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	461d769c-b787-4bc7-b4a6-7a5f33ae9d45	14
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	3424a326-9543-44f7-b31c-f84e12509238	13
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	3424a326-9543-44f7-b31c-f84e12509238	13
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	3424a326-9543-44f7-b31c-f84e12509238	13
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	cdd870a9-3bed-42fc-b175-48aed5321969	10
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	cdd870a9-3bed-42fc-b175-48aed5321969	10
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	cdd870a9-3bed-42fc-b175-48aed5321969	10
596926	DULoxetine 20 MG Delayed Release Oral Capsule	PSN	54749431-430e-4532-97f7-4b1cd8dd252e	3
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	54749431-430e-4532-97f7-4b1cd8dd252e	3
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	54749431-430e-4532-97f7-4b1cd8dd252e	3
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	2bd76155-709b-86ad-e063-6294a90aa1c5	3
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	54749431-430e-4532-97f7-4b1cd8dd252e	3
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	54749431-430e-4532-97f7-4b1cd8dd252e	3
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	54749431-430e-4532-97f7-4b1cd8dd252e	3
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	2bd76155-709b-86ad-e063-6294a90aa1c5	3
596926	duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	54749431-430e-4532-97f7-4b1cd8dd252e	3
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	54749431-430e-4532-97f7-4b1cd8dd252e	3
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	54749431-430e-4532-97f7-4b1cd8dd252e	3
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	2bd76155-709b-86ad-e063-6294a90aa1c5	3
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	19afed24-39ad-daf1-e063-6394a90ad737	2
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	19afed24-39ad-daf1-e063-6394a90ad737	2
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	c877bb68-759f-4d45-8bef-872554da4551	2
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	71256b03-867f-4c5e-aa5d-75d1bb705fcb	2
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	3f649b01-0969-cc71-e063-6394a90a9df5	2
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	19afed24-39ad-daf1-e063-6394a90ad737	2
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	3f649b01-0969-cc71-e063-6394a90a9df5	2
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	c877bb68-759f-4d45-8bef-872554da4551	2
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	19afed24-39ad-daf1-e063-6394a90ad737	2
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	71256b03-867f-4c5e-aa5d-75d1bb705fcb	2
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	19afed24-39ad-daf1-e063-6394a90ad737	2
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	3f649b01-0969-cc71-e063-6394a90a9df5	2
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	71256b03-867f-4c5e-aa5d-75d1bb705fcb	2
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	c877bb68-759f-4d45-8bef-872554da4551	2
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	19afed24-39ad-daf1-e063-6394a90ad737	2
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	2c288791-2d8f-84bb-e063-6294a90a7e1e	1
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	5584c5ed-cab6-4c8b-8307-41e5d77704d0	1
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	4f205401-39ac-7009-e063-6394a90aaa8c	1
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	2c288791-2d8f-84bb-e063-6294a90a7e1e	1
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	4f205401-39ac-7009-e063-6394a90aaa8c	1
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	5584c5ed-cab6-4c8b-8307-41e5d77704d0	1
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	2c288791-2d8f-84bb-e063-6294a90a7e1e	1
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	4f205401-39ac-7009-e063-6394a90aaa8c	1
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	5584c5ed-cab6-4c8b-8307-41e5d77704d0	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68180-296-03	68180029603	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68180-296-03)	2013-12-11	0000-00-00	No	No	Current
68180-296-06	68180029606	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68180-296-06)	2013-12-11	0000-00-00	No	No	Current
68180-296-09	68180029609	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68180-296-09)	2014-06-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Duloxetine	REMEDYREPACK INC.	2026-08-10	HUMAN PRESCRIPTION DRUG LABEL	19
Duloxetine	Golden State Medical Supply, Inc.	2026-08-10	HUMAN PRESCRIPTION DRUG LABEL	2
Duloxetine	Bryant Ranch Prepack	2026-08-03	HUMAN PRESCRIPTION DRUG LABEL	1
Duloxetine	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2026-05-20	HUMAN PRESCRIPTION DRUG LABEL	26
Duloxetine	Bryant Ranch Prepack	2026-05-08	HUMAN PRESCRIPTION DRUG LABEL	2
Duloxetine	QPharma, Inc. \| LUPIN LIMITED \| Northwind Health Company, LLC	2026-04-10	HUMAN PRESCRIPTION DRUG LABEL	1
Duloxetine	A-S Medication Solutions	2026-02-17	HUMAN PRESCRIPTION DRUG LABEL	13
Duloxetine	A-S Medication Solutions	2026-02-17	HUMAN PRESCRIPTION DRUG LABEL	10
Duloxetine	Coupler LLC \| LUPIN LIMITED	2026-01-09	HUMAN PRESCRIPTION DRUG LABEL	2
Duloxetine	Bryant Ranch Prepack	2025-06-02	HUMAN PRESCRIPTION DRUG LABEL	1
Duloxetine	Preferred Pharmaceuticals Inc.	2025-04-04	HUMAN PRESCRIPTION DRUG LABEL	2
Duloxetine D/R	Direct_Rx	2025-02-25	HUMAN PRESCRIPTION DRUG LABEL	3
Duloxetine	NuCare Pharmaceuticals, Inc.	2025-01-20	HUMAN PRESCRIPTION DRUG LABEL	1
Duloxetine	NCS HealthCare of KY, LLC dba Vangard Labs	2025-01-03	HUMAN PRESCRIPTION DRUG LABEL	3
Duloxetine	Quality Care Products, LLC	2024-12-19	HUMAN PRESCRIPTION DRUG LABEL	4
Duloxetine	Advanced Rx of Tennessee, LLC	2024-10-22	HUMAN PRESCRIPTION DRUG LABEL	2