Duloxetine

Product NDC: 51991-746
11-digit product format: 519910746
Labeler code: 51991
Product ID: 51991-746_32327581-bdab-41ac-9adc-bf208e1c4e42
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DULOXETINE HYDROCHLORIDE
Dosage form: CAPSULE, DELAYED RELEASE PELLETS
Route: ORAL
Labeler: Breckenridge Pharmaceutical, Inc.
Application: ANDA203088
Marketing category: ANDA
Marketing start: 2014-06-11
Substance: DULOXETINE HYDROCHLORIDE
Active strength: 20 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
A203088-001	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11
A203088-002	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11
A203088-003	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11
A203088-004	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-05-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203088-001	AB
A203088-002	AB
A203088-003	AB
A203088-004	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	A203088-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203088-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203088-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203088-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203088-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203088-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203088-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203088-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203088-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203088-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203088-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203088-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203088-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203088-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203088-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203088-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203088-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203088-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203088-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203088-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203088-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203088-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203088-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203088-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203088-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203088-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203088-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203088-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203088-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203088-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203088-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203088-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203088-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203088-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203088-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203088-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203088-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203088-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203088-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-06-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203088-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-05-18	`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	A203088-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203088-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203088-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203088-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203088-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203088-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203088-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203088-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203088-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203088-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203088-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203088-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203088-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203088-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203088-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203088-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203088-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203088-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203088-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203088-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203088-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203088-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203088-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203088-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203088-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203088-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203088-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203088-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203088-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203088-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203088-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203088-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203088-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203088-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203088-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203088-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203088-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203088-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203088-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203088-004	AB	1	`d06236e962d9…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DULOXETINE HYDROCHLORIDE	20 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
caef6f50-1571-4ec7-8f8c-42b924d323ee	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
51991-746-05	Duloxetine Delayed-Release	500 in 1 BOTTLE	CAPSULE, DELAYED RELEASE PELLETS	500	26
51991-746-06	Duloxetine Delayed-Release	60 in 1 BOTTLE	CAPSULE, DELAYED RELEASE PELLETS	60	26
51991-746-90	Duloxetine Delayed-Release	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE PELLETS	90	26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51991-746-05	EA - Each	51991-746	5ab1071a-03f6-4051-9488-aaba31e1cfbc	1	2014-07-02
51991-746-90	EA - Each	51991-746	af9e7f1f-194f-4b67-a757-ebc4bc04ae7f	1	2014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DULOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	9044SC542W	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]	8
DULOXETINE	ACTIVE MOIETY	O5TNM5N07U	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]	8
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]	8
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]	8
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]	8
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]	8
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]	8
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]	8
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]	8
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]	8
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]	8
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]	8
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]	8
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]	8
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]	8
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]	8
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]	8
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]	8
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]	8
DULOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	9044SC542W	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
DULOXETINE	ACTIVE MOIETY	O5TNM5N07U	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51991-746	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.]	26	Current NDC, Legacy NDC, 3 package rows	20250209_caef6f50-1571-4ec7-8f8c-42b924d323ee.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 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	REMEDYREPACK INC.	b9f20917-9529-4c62-bafe-baae7f8d6c77	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	29eacc40-cbec-4cc9-8556-773346617e85	2026-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine	DULOXETINE HYDROCHLORIDE	Quallent Pharmaceuticals Health, LLC	31362045-201f-45f3-99f2-a5e322a0c30b	2025-11-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	f535fcd2-a50a-4423-85d9-705fd2d9a470	2025-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3bae1317-4cc8-4d86-b1b6-15edee733a6d	2025-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	2c233b3f-83de-40c4-9f1d-81f901f89459	2025-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	f66f63c8-51db-4183-a452-78205cf3a263	2025-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	276ca221-354c-484d-93d5-0698cb2cfd56	2025-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	a23e79b3-7bd3-4b83-beb0-dc23d4830e9e	2025-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	a5804a0b-ceae-4ebd-bba0-bfc10e21b90d	2025-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	a891f20f-83ff-4960-81ef-9e74d01a452e	2025-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	c934cc41-b40b-4c5c-b019-a749eec52d88	2025-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	00628e5e-4c5b-2573-e063-6294a90a0e3b	2025-03-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	ca36f94c-2215-436f-ada8-7319f4f3e054	2025-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	b25c01e0-273a-4f8f-a37e-9b17e5cf378f	2025-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Breckenridge Pharmaceutical, Inc.	caef6f50-1571-4ec7-8f8c-42b924d323ee	2025-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088 ndc (product): 51991-746
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	df61b895-c358-827b-e053-2995a90a9b60	2024-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	41876761-9d5b-4190-a200-6a822c54582e	2024-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	0c82422a-d493-4dda-8626-0d9baa25db8c	2024-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	ca376622-d32c-4e6e-8af4-8e24a8d20d83	2024-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203088 application number: ANDA203088

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9044SC542W	DULOXETINE HYDROCHLORIDE	136434-34-9	DULOXETINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
596926	DULoxetine 20 MG Delayed Release Oral Capsule	PSN	b25c01e0-273a-4f8f-a37e-9b17e5cf378f	105
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	b25c01e0-273a-4f8f-a37e-9b17e5cf378f	105
596926	duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	b25c01e0-273a-4f8f-a37e-9b17e5cf378f	105
596926	DULoxetine 20 MG Delayed Release Oral Capsule	PSN	a5804a0b-ceae-4ebd-bba0-bfc10e21b90d	102
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	a5804a0b-ceae-4ebd-bba0-bfc10e21b90d	102
596926	duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	a5804a0b-ceae-4ebd-bba0-bfc10e21b90d	102
596926	DULoxetine 20 MG Delayed Release Oral Capsule	PSN	caef6f50-1571-4ec7-8f8c-42b924d323ee	26
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	caef6f50-1571-4ec7-8f8c-42b924d323ee	26
616402	DULoxetine 40 MG Delayed Release Oral Capsule	PSN	caef6f50-1571-4ec7-8f8c-42b924d323ee	26
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	caef6f50-1571-4ec7-8f8c-42b924d323ee	26
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	caef6f50-1571-4ec7-8f8c-42b924d323ee	26
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	caef6f50-1571-4ec7-8f8c-42b924d323ee	26
616402	duloxetine 40 MG Delayed Release Oral Capsule	SCD	caef6f50-1571-4ec7-8f8c-42b924d323ee	26
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	caef6f50-1571-4ec7-8f8c-42b924d323ee	26
596926	duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	caef6f50-1571-4ec7-8f8c-42b924d323ee	26
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	caef6f50-1571-4ec7-8f8c-42b924d323ee	26
616402	duloxetine 40 MG (as duloxetine HCl 44.9 MG) Delayed Release Oral Capsule	SY	caef6f50-1571-4ec7-8f8c-42b924d323ee	26
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	caef6f50-1571-4ec7-8f8c-42b924d323ee	26
596926	DULoxetine 20 MG Delayed Release Oral Capsule	PSN	a891f20f-83ff-4960-81ef-9e74d01a452e	20
596926	DULoxetine 20 MG Delayed Release Oral Capsule	PSN	f535fcd2-a50a-4423-85d9-705fd2d9a470	20
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	f535fcd2-a50a-4423-85d9-705fd2d9a470	20
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	f535fcd2-a50a-4423-85d9-705fd2d9a470	20
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	f535fcd2-a50a-4423-85d9-705fd2d9a470	20
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	a891f20f-83ff-4960-81ef-9e74d01a452e	20
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	f535fcd2-a50a-4423-85d9-705fd2d9a470	20
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	f535fcd2-a50a-4423-85d9-705fd2d9a470	20
596926	duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	a891f20f-83ff-4960-81ef-9e74d01a452e	20
596926	duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	f535fcd2-a50a-4423-85d9-705fd2d9a470	20
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	f535fcd2-a50a-4423-85d9-705fd2d9a470	20
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	f535fcd2-a50a-4423-85d9-705fd2d9a470	20
596926	DULoxetine 20 MG Delayed Release Oral Capsule	PSN	29eacc40-cbec-4cc9-8556-773346617e85	6
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	29eacc40-cbec-4cc9-8556-773346617e85	6
596926	duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	29eacc40-cbec-4cc9-8556-773346617e85	6
596926	DULoxetine 20 MG Delayed Release Oral Capsule	PSN	be33f3cb-6fd1-4377-816e-84bd49370e9e	5
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	be33f3cb-6fd1-4377-816e-84bd49370e9e	5
596926	duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	be33f3cb-6fd1-4377-816e-84bd49370e9e	5
596926	DULoxetine 20 MG Delayed Release Oral Capsule	PSN	9078217c-16f4-a543-e053-2a95a90a31f2	4
596926	DULoxetine 20 MG Delayed Release Oral Capsule	PSN	7000c48f-77f3-4447-b223-fde99886ed30	4
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	9078217c-16f4-a543-e053-2a95a90a31f2	4
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	7000c48f-77f3-4447-b223-fde99886ed30	4
596926	duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	9078217c-16f4-a543-e053-2a95a90a31f2	4
596926	duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	7000c48f-77f3-4447-b223-fde99886ed30	4
596926	DULoxetine 20 MG Delayed Release Oral Capsule	PSN	407b62b9-5b32-4bac-a2b0-7df499279248	3
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	407b62b9-5b32-4bac-a2b0-7df499279248	3
596926	duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	407b62b9-5b32-4bac-a2b0-7df499279248	3
596926	DULoxetine 20 MG Delayed Release Oral Capsule	PSN	df61b895-c358-827b-e053-2995a90a9b60	2
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	df61b895-c358-827b-e053-2995a90a9b60	2
596926	duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	df61b895-c358-827b-e053-2995a90a9b60	2
596926	DULoxetine 20 MG Delayed Release Oral Capsule	PSN	7dc9638a-dbba-c190-e053-2a91aa0a1be9	1
596926	DULoxetine 20 MG Delayed Release Oral Capsule	PSN	441a46f0-ecc7-4448-e054-00144ff88e88	1
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	7dc9638a-dbba-c190-e053-2a91aa0a1be9	1
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	441a46f0-ecc7-4448-e054-00144ff88e88	1
596926	duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	441a46f0-ecc7-4448-e054-00144ff88e88	1
596926	duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	7dc9638a-dbba-c190-e053-2a91aa0a1be9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
51991-746-05	51991074605	500 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51991-746-05)	2014-06-11	0000-00-00	No	No	Current
51991-746-06	51991074606	60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51991-746-06)	2014-06-11	0000-00-00	No	No	Current
51991-746-90	51991074690	90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51991-746-90)	2014-06-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Duloxetine Delayed-Release	Preferred Pharmaceuticals Inc.	2026-04-08	HUMAN PRESCRIPTION DRUG LABEL	6
Duloxetine Delayed-Release	Golden State Medical Supply, Inc.	2025-07-22	HUMAN PRESCRIPTION DRUG LABEL	20
Duloxetine Delayed-Release	Bryant Ranch Prepack	2025-04-01	HUMAN PRESCRIPTION DRUG LABEL	102
Duloxetine Delayed-Release	Bryant Ranch Prepack	2025-03-28	HUMAN PRESCRIPTION DRUG LABEL	20
Duloxetine Delayed-Release	Bryant Ranch Prepack	2025-03-19	HUMAN PRESCRIPTION DRUG LABEL	105
Duloxetine Delayed-Release	Breckenridge Pharmaceutical, Inc. \| Towa Pharmaceutical Europe, S.L. \| Apace Packaging LLC	2025-01-31	HUMAN PRESCRIPTION DRUG LABEL	26
Duloxetine Delayed-Release - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2024-12-26	HUMAN PRESCRIPTION DRUG LABEL	2
Duloxetine Delayed-Release	A-S Medication Solutions	2024-06-10	HUMAN PRESCRIPTION DRUG LABEL	5
DULOXETINE D/R	Direct_Rx	2023-01-12	HUMAN PRESCRIPTION DRUG LABEL	4
DULOXETINE DELAYED-RELEASE	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	3
DULOXETINE DELAYED-RELEASE	Preferred Pharmaceuticals Inc.	2019-09-03	HUMAN PRESCRIPTION DRUG LABEL	4
Duloxetine Delayed-Release	medsource pharmaceuticals	2018-12-24	HUMAN PRESCRIPTION DRUG LABEL	1
DULOXETINE D/R	DIRECT RX	2016-12-20	HUMAN PRESCRIPTION DRUG LABEL	1