DULOXETINE DELAYED-RELEASE CAPSULES

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-11-28
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-05-31 21:18:26

Label at a glance#

ProductDuloxetine

Active ingredientDULOXETINE HYDROCHLORIDE

Label structure2 sections

Label contents#

Full prescribing information#

SPL MEDGUIDE SECTION

Manufactured by:

Cadila Healthcare Ltd.

India

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-799-16

Duloxetine Delayed-release Capsules, 20mg

90 Capsules

Rx only

NDC 65841-800-16

Duloxetine Delayed-release Capsules, 30mg

90 Capsules

Rx only

NDC 65841-801-16

Duloxetine Delayed-release Capsules, 60mg

90 Capsules

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
596926	DULoxetine 20 MG Delayed Release Oral Capsule	PSN	7
596930	DULoxetine 30 MG Delayed Release Oral Capsule	PSN	7
596934	DULoxetine 60 MG Delayed Release Oral Capsule	PSN	7
596926	duloxetine 20 MG Delayed Release Oral Capsule	SCD	7
596930	duloxetine 30 MG Delayed Release Oral Capsule	SCD	7
596934	duloxetine 60 MG Delayed Release Oral Capsule	SCD	7
596926	duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	7
596930	duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule	SY	7
596934	duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	7

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DULOXETINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

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
65841-799-06	Duloxetine	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	7
65841-799-14	Duloxetine	60 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	60	7
65841-799-16	Duloxetine	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	7
65841-800-06	Duloxetine	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	7
65841-800-10	Duloxetine	1000 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	1000	7
65841-800-16	Duloxetine	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	7
65841-801-06	Duloxetine	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	7
65841-801-10	Duloxetine	1000 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	1000	7
65841-801-16	Duloxetine	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65841-799	DULOXETINE CAPSULE, DELAYED RELEASE [ZYDUS LIFESCIENCES LIMITED]	7	Current NDC, Legacy NDC, 3 package rows	20241201_f36b414e-ace4-4f04-a80f-75bb25db430d.zip
65841-800	DULOXETINE CAPSULE, DELAYED RELEASE [ZYDUS LIFESCIENCES LIMITED]	7	Current NDC, Legacy NDC, 3 package rows	20241201_f36b414e-ace4-4f04-a80f-75bb25db430d.zip
65841-801	DULOXETINE CAPSULE, DELAYED RELEASE [ZYDUS LIFESCIENCES LIMITED]	7	Current NDC, Legacy NDC, 3 package rows	20241201_f36b414e-ace4-4f04-a80f-75bb25db430d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DULOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	9044SC542W	1
DULOXETINE	ACTIVE MOIETY	O5TNM5N07U	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	1
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)	INACTIVE INGREDIENT	G4U024CQK6	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

Duloxetine
DULOXETINE HYDROCHLORIDE
ALCOHOL
AMMONIA
BUTYL ALCOHOL
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
FERRIC OXIDE YELLOW
GELATIN
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)
HYPROMELLOSES
ISOPROPYL ALCOHOL
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
STARCH, CORN
SUCROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
FD&C RED NO. 40

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65841-799	65841-799-06, 65841-799-14, 65841-799-16
65841-800	65841-800-06, 65841-800-16, 65841-800-10
65841-801	65841-801-06, 65841-801-16, 65841-801-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 60 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DULOXETINE HYDROCHLORIDE	9044SC542W	ACTIM
ALCOHOL	3K9958V90M	IACT
AMMONIA	5138Q19F1X	IACT
BUTYL ALCOHOL	8PJ61P6TS3	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
GELATIN	2G86QN327L	IACT
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)	G4U024CQK6	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SHELLAC	46N107B71O	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
STARCH, CORN	O8232NY3SJ	IACT
SUCROSE	C151H8M554	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIETHYL CITRATE	8Z96QXD6UM	IACT
DULOXETINE HYDROCHLORIDE	9044SC542W	ACTIM
FD&C BLUE NO. 1	H3R47K3TBD	IACT
GELATIN	2G86QN327L	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)	G4U024CQK6	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SUCROSE	C151H8M554	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIETHYL CITRATE	8Z96QXD6UM	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
BUTYL ALCOHOL	8PJ61P6TS3	IACT
ALCOHOL	3K9958V90M	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SHELLAC	46N107B71O	IACT
AMMONIA	5138Q19F1X	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 360 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, DELAYED RELEASE / ORAL		216 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / ORAL	150.68 mg/1ml		Exact identifier — unii+route 132 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SUSPENSION / ORAL		681 mg	Exact identifier — unii+route 132 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, DELAYED RELEASE / ORAL	0.02 mg		Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE / ORAL		882 mg	Exact identifier — unii+route 132 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	CAPSULE, DELAYED RELEASE / ORAL		70 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	CAPSULE, DELAYED RELEASE / ORAL		70 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 12 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / ORAL	150.68 mg/1ml		Exact identifier — unii+route 132 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CONCENTRATE / ORAL	198 mg		Exact identifier — unii+route 132 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, DELAYED RELEASE / ORAL		46 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, DELAYED RELEASE / ORAL		1791 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE, DELAYED RELEASE / ORAL		1 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / ORAL	150.68 mg/1ml		Exact identifier — unii+route 132 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE / ORAL		882 mg	Exact identifier — unii+route 132 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, DELAYED RELEASE / ORAL		1791 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	ELIXIR / ORAL		13675 mg	Exact identifier — unii+route 132 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, DELAYED RELEASE / ORAL		105 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 12 equally ranked IID candidates
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)	HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)	G4U024CQK6	CAPSULE, DELAYED RELEASE / ORAL		586 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE, DELAYED RELEASE / ORAL		1 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)	HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)	G4U024CQK6	CAPSULE, DELAYED RELEASE / ORAL		586 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / ORAL		6624 mg	Exact identifier — unii+route 132 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, DELAYED RELEASE / ORAL		216 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii+route 132 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	CAPSULE, DELAYED RELEASE / ORAL		1 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	DROPS / ORAL	210 mg/1ml		Exact identifier — unii+route 132 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 12 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, DELAYED RELEASE / ORAL		1791 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, DELAYED RELEASE / ORAL		420 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	CAPSULE, DELAYED RELEASE / ORAL		70 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, DELAYED RELEASE / ORAL		216 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	ELIXIR / ORAL		13675 mg	Exact identifier — unii+route 132 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / ORAL	150.68 mg/1ml		Exact identifier — unii+route 132 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii+route 132 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, DELAYED RELEASE / ORAL		46 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, DELAYED RELEASE / ORAL		105 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / ORAL		3563 mg	Exact identifier — unii+route 132 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, DELAYED RELEASE / ORAL		1791 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	CAPSULE, DELAYED RELEASE / ORAL		1 mg	Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, DELAYED RELEASE / ORAL	0.02 mg		Exact identifier — unii+route+dosage form 12 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, DELAYED RELEASE / ORAL	1.7 mg		Exact identifier — unii+route+dosage form 12 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A090739-001	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08
A090739-002	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08
A090739-003	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08
A090739-004	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2023-04-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090739-001	AB
A090739-002	AB
A090739-003	AB
A090739-004	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 4 · 153 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
2026-09-14 22:38:34	2026-08	A090739-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090739-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090739-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090739-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2023-04-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090739-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090739-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090739-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090739-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2023-04-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090739-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090739-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090739-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090739-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2023-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090739-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090739-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090739-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090739-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2023-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090739-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090739-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090739-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090739-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2023-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090739-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090739-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090739-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090739-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2023-04-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090739-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090739-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090739-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090739-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2023-04-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090739-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090739-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090739-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090739-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2023-04-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090739-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090739-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090739-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090739-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2023-04-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090739-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090739-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090739-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090739-004	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2023-04-18	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 153 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090739-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090739-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090739-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090739-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090739-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090739-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090739-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090739-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090739-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090739-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090739-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090739-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090739-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090739-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090739-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090739-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090739-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090739-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090739-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090739-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090739-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090739-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090739-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090739-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090739-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090739-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090739-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090739-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090739-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090739-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090739-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090739-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090739-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090739-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090739-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090739-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090739-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090739-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090739-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090739-004	AB	1	`5bbf6a4d5a75…`

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	Zydus Lifesciences Limited	f36b414e-ace4-4f04-a80f-75bb25db430d	2024-11-28		Exact identifier ndc (package): 65841-800-16 ndc (package): 65841-799-14 ndc (package): 65841-801-10 ndc (package): 65841-800-06 ndc (package): 65841-799-16 ndc (package): 65841-801-16 ndc (package): 65841-800-10 ndc (package): 65841-801-06 ndc (package): 65841-799-06 ndc (product): 65841-800 ndc (product): 65841-801 ndc (product): 65841-799 ndc11 (package): 65841080106 ndc11 (package): 65841080010 ndc11 (package): 65841080110 ndc11 (package): 65841079906 ndc11 (package): 65841080116 ndc11 (package): 65841080006 ndc11 (package): 65841080016 ndc11 (package): 65841079916 ndc11 (package): 65841079914 spl id: 22968719-7127-4aab-b4c4-4497de16ca23 spl set id: f36b414e-ace4-4f04-a80f-75bb25db430d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.