Duloxetine

Product NDC: 51991-747
11-digit product format: 519910747
Labeler code: 51991
Product ID: 51991-747_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: 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

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	30 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	9044SC542W
Rxcui	596926, 596930, 596934, 616402

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
51991-747-10	Duloxetine Delayed-Release	1000 in 1 BOTTLE	CAPSULE, DELAYED RELEASE PELLETS	1000	26
51991-747-33	Duloxetine Delayed-Release	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE PELLETS	30	26
51991-747-90	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
51991-747-10	EA - Each	51991-747	5395a3cc-ddb7-4f3f-95ec-d0ab5fd59ca9	1	2014-07-02
51991-747-90	EA - Each	51991-747	24ccc90a-3164-432a-a512-8b0508e144e0	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 HYDROCHLORIDE	ACTIVE INGREDIENT	9044SC542W	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [TYA PHARMACEUTICALS]	2
DULOXETINE	ACTIVE MOIETY	O5TNM5N07U	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 [TYA PHARMACEUTICALS]	2
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	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 [TYA PHARMACEUTICALS]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	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 [TYA PHARMACEUTICALS]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [TYA PHARMACEUTICALS]	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 [TYA PHARMACEUTICALS]	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 [TYA PHARMACEUTICALS]	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
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [TYA PHARMACEUTICALS]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	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 [TYA PHARMACEUTICALS]	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
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [TYA PHARMACEUTICALS]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	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 [TYA PHARMACEUTICALS]	2
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [TYA PHARMACEUTICALS]	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 [TYA PHARMACEUTICALS]	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
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [TYA PHARMACEUTICALS]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	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 [TYA PHARMACEUTICALS]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [TYA PHARMACEUTICALS]	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 [TYA PHARMACEUTICALS]	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 [TYA PHARMACEUTICALS]	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 [TYA PHARMACEUTICALS]	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
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [TYA PHARMACEUTICALS]	2
DULOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	9044SC542W	DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
DULOXETINE	ACTIVE MOIETY	O5TNM5N07U	DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51991-747	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

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
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	ca36f94c-2215-436f-ada8-7319f4f3e054	105
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	ca36f94c-2215-436f-ada8-7319f4f3e054	105
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	ca36f94c-2215-436f-ada8-7319f4f3e054	105
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	41876761-9d5b-4190-a200-6a822c54582e	104
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	41876761-9d5b-4190-a200-6a822c54582e	104
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	41876761-9d5b-4190-a200-6a822c54582e	104
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	276ca221-354c-484d-93d5-0698cb2cfd56	101
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	276ca221-354c-484d-93d5-0698cb2cfd56	101
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	276ca221-354c-484d-93d5-0698cb2cfd56	101
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	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
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	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
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	3eb24fa9-921b-4bdb-9e0a-c82cb600df0f	15
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	3eb24fa9-921b-4bdb-9e0a-c82cb600df0f	15
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	3eb24fa9-921b-4bdb-9e0a-c82cb600df0f	15
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	b07dc470-5899-40e8-9af2-559ddc75a4be	9
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	b07dc470-5899-40e8-9af2-559ddc75a4be	9
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	b07dc470-5899-40e8-9af2-559ddc75a4be	9
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	41c86c02-68c0-4db5-af1a-941b0d2ffe11	5
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	903d337f-494a-398f-e053-2a95a90a866e	5
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	903d337f-494a-398f-e053-2a95a90a866e	5
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	41c86c02-68c0-4db5-af1a-941b0d2ffe11	5
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	903d337f-494a-398f-e053-2a95a90a866e	5
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	41c86c02-68c0-4db5-af1a-941b0d2ffe11	5
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	c49f4fe2-1a2f-46fd-9dd1-45d54fdd1d75	4
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	c49f4fe2-1a2f-46fd-9dd1-45d54fdd1d75	4
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	c49f4fe2-1a2f-46fd-9dd1-45d54fdd1d75	4
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	c49f4fe2-1a2f-46fd-9dd1-45d54fdd1d75	4
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	c49f4fe2-1a2f-46fd-9dd1-45d54fdd1d75	4
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	c49f4fe2-1a2f-46fd-9dd1-45d54fdd1d75	4
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	dbd00f99-d190-48cd-85f4-b217b767aa1a	3
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	dbd00f99-d190-48cd-85f4-b217b767aa1a	3
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	dbd00f99-d190-48cd-85f4-b217b767aa1a	3
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	dbd00f99-d190-48cd-85f4-b217b767aa1a	3
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	dbd00f99-d190-48cd-85f4-b217b767aa1a	3
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	dbd00f99-d190-48cd-85f4-b217b767aa1a	3
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	ec5c1e56-bc06-46a5-a208-cc8186aca85b	2
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	ec5c1e56-bc06-46a5-a208-cc8186aca85b	2
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	ec5c1e56-bc06-46a5-a208-cc8186aca85b	2
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	db686a0a-9b2a-4017-8bd1-b981da47c2f3	1
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	c9f3b4f4-31ec-8c06-e053-2a95a90a962e	1
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	a853356e-fffe-5273-e053-2995a90a0f10	1
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	a853356e-fffe-5273-e053-2995a90a0f10	1
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	db686a0a-9b2a-4017-8bd1-b981da47c2f3	1
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	c9f3b4f4-31ec-8c06-e053-2a95a90a962e	1
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	a853356e-fffe-5273-e053-2995a90a0f10	1
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	a853356e-fffe-5273-e053-2995a90a0f10	1
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	c9f3b4f4-31ec-8c06-e053-2a95a90a962e	1
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	db686a0a-9b2a-4017-8bd1-b981da47c2f3	1
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	a853356e-fffe-5273-e053-2995a90a0f10	1
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	a853356e-fffe-5273-e053-2995a90a0f10	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
51991-747-10	51991074710	1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51991-747-10)	2014-06-11	0000-00-00	No	No	Current
51991-747-33	51991074733	30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51991-747-33)	2014-06-11	0000-00-00	No	No	Current
51991-747-90	51991074790	90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51991-747-90)	2014-06-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
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	101
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	Bryant Ranch Prepack	2024-08-20	HUMAN PRESCRIPTION DRUG LABEL	104
Duloxetine Delayed-Release	A-S Medication Solutions	2024-06-10	HUMAN PRESCRIPTION DRUG LABEL	15
DULOXETINE DELAYED-RELEASE	Proficient Rx LP	2024-02-01	HUMAN PRESCRIPTION DRUG LABEL	5
DULOXETINE HYDROCHLORIDE	Direct_Rx	2023-04-25	HUMAN PRESCRIPTION DRUG LABEL	5
Duloxetine Delayed-Release - Denton Pharma, Inc. dba Northwind Pharmaceuticals	Denton Pharma, Inc. dba Northwind Pharmaceuticals	2021-08-19	HUMAN PRESCRIPTION DRUG LABEL	1
Duloxetine Delayed-Release - Unit Dose Services	Unit Dose Services	2021-08-17	HUMAN PRESCRIPTION DRUG LABEL	3
Duloxetine Delayed-Release	Contract Pharmacy Services-PA \| Coupler Enterprises Inc.	2020-06-17	HUMAN PRESCRIPTION DRUG LABEL	1
Duloxetine Delayed-Release	Aphena Pharma Solutions - Tennessee, LLC	2019-01-11	HUMAN PRESCRIPTION DRUG LABEL	1
DULOXETINE HYDROCHLORIDE	DIRECT RX	2016-07-07	HUMAN PRESCRIPTION DRUG LABEL	9
DULOXETINE DELAYED-RELEASE	Blenheim Pharmacal, Inc.	2016-06-07	HUMAN PRESCRIPTION DRUG LABEL	4
DULOXETINE DELAYED-RELEASE	TYA Pharmaceuticals	2014-06-24	HUMAN PRESCRIPTION DRUG LABEL	2

Duloxetine

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#