Duloxetine

Product NDC: 47335-381
11-digit product format: 473350381
Labeler code: 47335
Product ID: 47335-381_cec0154d-5c8c-496d-89bd-ba2a93aee774
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Duloxetine
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA090745
Marketing category: ANDA
Marketing start: 2013-12-11
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A090745-001	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11
A090745-002	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11
A090745-003	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090745-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090745-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090745-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090745-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090745-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090745-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090745-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090745-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090745-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090745-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090745-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090745-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090745-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090745-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090745-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090745-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090745-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090745-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090745-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090745-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090745-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090745-001	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	A090745-002	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	A090745-003	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	A090745-001	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	A090745-002	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	A090745-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090745-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090745-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090745-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090745-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090745-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090745-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090745-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090745-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090745-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090745-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090745-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090745-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090745-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090745-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090745-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090745-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090745-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090745-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090745-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090745-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090745-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090745-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090745-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090745-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090745-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090745-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090745-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090745-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090745-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090745-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090745-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090745-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090745-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090745-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090745-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090745-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090745-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090745-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090745-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090745-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090745-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090745-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090745-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090745-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090745-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090745-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090745-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090745-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090745-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090745-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090745-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090745-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090745-001	AB	1	`87673890dc5c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Duloxetine
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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
596926	Internal RxNorm lookup
596930	Internal RxNorm lookup
596934	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
f16beb64-5878-486a-82ee-8e83e728f26c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
aebfdb62-b550-4c4f-9225-d5d3bbc7ab88	Product name	9	20210727
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
7dd29e28-6b69-499b-9257-12a3b46ca283	Product name	1	20191120
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
47335-381-08	Duloxetine	100 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	100	16
47335-381-18	Duloxetine	1000 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	1000	16
47335-381-61	Duloxetine	1 in 1 BLISTER PACK	CAPSULE, DELAYED RELEASE	1	16
47335-381-61	Duloxetine	100 in 1 CARTON	CAPSULE, DELAYED RELEASE	100	16
47335-381-83	Duloxetine	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	16
47335-381-86	Duloxetine	60 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	60	16
47335-381-88	Duloxetine	100 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	100	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47335-381-86	EA - Each	47335-381	20374e9c-629a-4eb6-b5fd-6e8e1268f07c	1	2014-01-04
47335-381-88	EA - Each	47335-381	95254eb8-8dbd-472e-8d77-07f2e329cbeb	1	2014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DULOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	9044SC542W	DULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]	6
DULOXETINE	ACTIVE MOIETY	O5TNM5N07U	DULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]	6
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]	6
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]	6
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	DULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]	6
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]	6
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]	6
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]	6
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]	6
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	DULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]	6
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	DULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]	6
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	DULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]	6
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	DULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]	6
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]	6
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	DULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]	6
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]	6
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	DULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	DULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMA GLOBAL FZE]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47335-381	DULOXETINE CAPSULE, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	16	Current NDC, Legacy NDC, 7 package rows	20211113_f16beb64-5878-486a-82ee-8e83e728f26c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Duloxetine	DULOXETINE	Sun Pharmaceutical Industries, Inc.	f16beb64-5878-486a-82ee-8e83e728f26c	2021-11-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090745 application number: ANDA090745 ndc (product): 47335-381

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	f16beb64-5878-486a-82ee-8e83e728f26c	16
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	f16beb64-5878-486a-82ee-8e83e728f26c	16
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	f16beb64-5878-486a-82ee-8e83e728f26c	16
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	f16beb64-5878-486a-82ee-8e83e728f26c	16
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	f16beb64-5878-486a-82ee-8e83e728f26c	16
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	f16beb64-5878-486a-82ee-8e83e728f26c	16
596926	duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	f16beb64-5878-486a-82ee-8e83e728f26c	16
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	f16beb64-5878-486a-82ee-8e83e728f26c	16
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	f16beb64-5878-486a-82ee-8e83e728f26c	16
596926	DULoxetine 20 MG Delayed Release Oral Capsule	PSN	48fb3410-bb87-42ce-e054-00144ff88e88	2
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	48fb3410-bb87-42ce-e054-00144ff88e88	2
596926	duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	48fb3410-bb87-42ce-e054-00144ff88e88	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
47335-381-08	47335038108	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-381-08)		2013-12-11	0000-00-00	No	No	Current
47335-381-18	47335038118	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-381-18)		2013-12-11	0000-00-00	No	No	Current
47335-381-61	47335038161	100 BLISTER PACK in 1 CARTON (47335-381-61) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK	100 blister pack	2013-12-11	0000-00-00	No	No	Current
47335-381-83	47335038183	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-381-83)		2013-12-11	0000-00-00	No	No	Current
47335-381-86	47335038186	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-381-86)		2013-12-11	0000-00-00	No	No	Current
47335-381-88	47335038188	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-381-88)		2013-12-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Duloxetine	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2021-11-08	Human Prescription Drug Label	16
DULOXETINE	DIRECT RX	2017-02-21	HUMAN PRESCRIPTION DRUG LABEL	2