DRIZALMA SPRINKLE

Product NDC: 47335-617
11-digit product format: 473350617
Labeler code: 47335
Product ID: 47335-617_67134e3c-1819-4262-a36f-460afdbb165d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Duloxetine
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: SUN PHARMACEUTICAL INDUSTRIES, INC.
Application: NDA212516
Marketing category: NDA
Marketing start: 2024-06-10
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

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	RLD / RS	Approval date
N212516-001	DRIZALMA SPRINKLE	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19
N212516-002	DRIZALMA SPRINKLE	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19
N212516-003	DRIZALMA SPRINKLE	DULOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19
N212516-004	DRIZALMA SPRINKLE	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2019-07-19

Orange Book patents#

Current patent rows page 1 of 1 · 20 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N212516-001	10413525	2037-04-13	Drug product	2019-10-07
N212516-001	10959982	2037-04-13	Drug product	2021-04-19
N212516-001	11202772	2037-04-13	Drug product	2022-02-01
N212516-001	12171742	2037-04-13	Drug product	2025-01-10
N212516-001	9839626	2037-04-13	Drug product	2019-08-02
N212516-002	10413525	2037-04-13	Drug product	2019-10-07
N212516-002	10959982	2037-04-13	Drug product	2021-04-19
N212516-002	11202772	2037-04-13	Drug product	2022-02-01
N212516-002	12171742	2037-04-13	Drug product	2025-01-10
N212516-002	9839626	2037-04-13	Drug product	2019-08-02
N212516-003	10413525	2037-04-13	Drug product	2019-10-07
N212516-003	10959982	2037-04-13	Drug product	2021-04-19
N212516-003	11202772	2037-04-13	Drug product	2022-02-01
N212516-003	12171742	2037-04-13	Drug product	2025-01-10
N212516-003	9839626	2037-04-13	Drug product	2019-08-02
N212516-004	10413525	2037-04-13	Drug product	2019-10-07
N212516-004	10959982	2037-04-13	Drug product	2021-04-19
N212516-004	11202772	2037-04-13	Drug product	2022-02-01
N212516-004	12171742	2037-04-13	Drug product	2025-01-10
N212516-004	9839626	2037-04-13	Drug product	2019-08-02

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 · 160 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212516-001	DRIZALMA SPRINKLE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-002	DRIZALMA SPRINKLE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-003	DRIZALMA SPRINKLE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-004	DRIZALMA SPRINKLE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2019-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-001	DRIZALMA SPRINKLE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-002	DRIZALMA SPRINKLE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-003	DRIZALMA SPRINKLE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-004	DRIZALMA SPRINKLE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2019-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212516-001	DRIZALMA SPRINKLE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212516-002	DRIZALMA SPRINKLE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212516-003	DRIZALMA SPRINKLE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212516-004	DRIZALMA SPRINKLE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2019-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212516-001	DRIZALMA SPRINKLE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212516-002	DRIZALMA SPRINKLE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212516-003	DRIZALMA SPRINKLE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212516-004	DRIZALMA SPRINKLE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2019-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212516-001	DRIZALMA SPRINKLE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212516-002	DRIZALMA SPRINKLE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212516-003	DRIZALMA SPRINKLE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212516-004	DRIZALMA SPRINKLE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2019-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212516-001	DRIZALMA SPRINKLE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212516-002	DRIZALMA SPRINKLE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212516-003	DRIZALMA SPRINKLE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212516-004	DRIZALMA SPRINKLE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2019-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212516-001	DRIZALMA SPRINKLE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212516-002	DRIZALMA SPRINKLE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212516-003	DRIZALMA SPRINKLE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212516-004	DRIZALMA SPRINKLE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2019-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212516-001	DRIZALMA SPRINKLE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212516-002	DRIZALMA SPRINKLE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212516-003	DRIZALMA SPRINKLE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212516-004	DRIZALMA SPRINKLE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2019-07-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212516-001	DRIZALMA SPRINKLE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212516-002	DRIZALMA SPRINKLE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212516-003	DRIZALMA SPRINKLE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212516-004	DRIZALMA SPRINKLE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2019-07-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212516-001	DRIZALMA SPRINKLE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212516-002	DRIZALMA SPRINKLE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212516-003	DRIZALMA SPRINKLE	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2019-07-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212516-004	DRIZALMA SPRINKLE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2019-07-19	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 15 · 600 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212516-001	10413525	2037-04-13	Drug product	2019-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-001	10959982	2037-04-13	Drug product	2021-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-001	11202772	2037-04-13	Drug product	2022-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-001	12171742	2037-04-13	Drug product	2025-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-001	9839626	2037-04-13	Drug product	2019-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-002	10413525	2037-04-13	Drug product	2019-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-002	10959982	2037-04-13	Drug product	2021-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-002	11202772	2037-04-13	Drug product	2022-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-002	12171742	2037-04-13	Drug product	2025-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-002	9839626	2037-04-13	Drug product	2019-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-003	10413525	2037-04-13	Drug product	2019-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-003	10959982	2037-04-13	Drug product	2021-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-003	11202772	2037-04-13	Drug product	2022-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-003	12171742	2037-04-13	Drug product	2025-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-003	9839626	2037-04-13	Drug product	2019-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-004	10413525	2037-04-13	Drug product	2019-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-004	10959982	2037-04-13	Drug product	2021-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-004	11202772	2037-04-13	Drug product	2022-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-004	12171742	2037-04-13	Drug product	2025-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212516-004	9839626	2037-04-13	Drug product	2019-08-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-001	10413525	2037-04-13	Drug product	2019-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-001	10959982	2037-04-13	Drug product	2021-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-001	11202772	2037-04-13	Drug product	2022-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-001	12171742	2037-04-13	Drug product	2025-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-001	9839626	2037-04-13	Drug product	2019-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-002	10413525	2037-04-13	Drug product	2019-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-002	10959982	2037-04-13	Drug product	2021-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-002	11202772	2037-04-13	Drug product	2022-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-002	12171742	2037-04-13	Drug product	2025-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-002	9839626	2037-04-13	Drug product	2019-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-003	10413525	2037-04-13	Drug product	2019-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-003	10959982	2037-04-13	Drug product	2021-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-003	11202772	2037-04-13	Drug product	2022-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-003	12171742	2037-04-13	Drug product	2025-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-003	9839626	2037-04-13	Drug product	2019-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-004	10413525	2037-04-13	Drug product	2019-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-004	10959982	2037-04-13	Drug product	2021-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-004	11202772	2037-04-13	Drug product	2022-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-004	12171742	2037-04-13	Drug product	2025-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212516-004	9839626	2037-04-13	Drug product	2019-08-02	`31067a03dcf5…`

Additional Listing Data#

Finished product: Yes
Brand name base: DRIZALMA SPRINKLE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DULOXETINE HYDROCHLORIDE	30 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 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2200168	Internal RxNorm lookup
2200174	Internal RxNorm lookup
2200175	Internal RxNorm lookup
2200177	Internal RxNorm lookup
2200178	Internal RxNorm lookup
2200180	Internal RxNorm lookup
2200181	Internal RxNorm lookup
2200183	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
b41423b8-dfec-4d79-ba3c-e43a87803d85	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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
47335-617-10	DRIZALMA SPRINKLE	1000 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	1000	6
47335-617-30	DRIZALMA SPRINKLE	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	6
47335-617-60	DRIZALMA SPRINKLE	60 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	60	6
47335-617-90	DRIZALMA SPRINKLE	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47335-617-30	EA - Each	47335-617	9185ffd7-311d-403c-98e1-d42a78d688b6	1	2019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47335-617	DRIZALMA SPRINKLE (DULOXETINE) CAPSULE, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6	Current NDC, Legacy NDC, 4 package rows	20240611_b41423b8-dfec-4d79-ba3c-e43a87803d85.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
DRIZALMA SPRINKLE	DULOXETINE	SUN PHARMACEUTICAL INDUSTRIES, INC.	b41423b8-dfec-4d79-ba3c-e43a87803d85	2024-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 212516 application number: NDA212516 ndc (product): 47335-617

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
2200174	DRIZALMA 20 MG Delayed Release Oral Capsule	PSN	b41423b8-dfec-4d79-ba3c-e43a87803d85	6
2200177	DRIZALMA 30 MG Delayed Release Oral Capsule	PSN	b41423b8-dfec-4d79-ba3c-e43a87803d85	6
2200180	Drizalma 40 MG Delayed Release Oral Capsule	PSN	b41423b8-dfec-4d79-ba3c-e43a87803d85	6
2200183	Drizalma 60 MG Delayed Release Oral Capsule	PSN	b41423b8-dfec-4d79-ba3c-e43a87803d85	6
2200168	DULoxetine 20 MG Sprinkle Delayed Release Oral Capsule	PSN	b41423b8-dfec-4d79-ba3c-e43a87803d85	6
2200175	DULoxetine 30 MG Sprinkle Delayed Release Oral Capsule	PSN	b41423b8-dfec-4d79-ba3c-e43a87803d85	6
2200178	DULoxetine 40 MG Sprinkle Delayed Release Oral Capsule	PSN	b41423b8-dfec-4d79-ba3c-e43a87803d85	6
2200181	DULoxetine 60 MG Sprinkle Delayed Release Oral Capsule	PSN	b41423b8-dfec-4d79-ba3c-e43a87803d85	6
2200174	Sprinkle duloxetine 20 MG Delayed Release Oral Capsule [Drizalma]	SBD	b41423b8-dfec-4d79-ba3c-e43a87803d85	6
2200177	Sprinkle duloxetine 30 MG Delayed Release Oral Capsule [Drizalma]	SBD	b41423b8-dfec-4d79-ba3c-e43a87803d85	6
2200180	Sprinkle duloxetine 40 MG Delayed Release Oral Capsule [Drizalma]	SBD	b41423b8-dfec-4d79-ba3c-e43a87803d85	6
2200183	Sprinkle duloxetine 60 MG Delayed Release Oral Capsule [Drizalma]	SBD	b41423b8-dfec-4d79-ba3c-e43a87803d85	6
2200168	Sprinkle duloxetine 20 MG Delayed Release Oral Capsule	SCD	b41423b8-dfec-4d79-ba3c-e43a87803d85	6
2200175	Sprinkle duloxetine 30 MG Delayed Release Oral Capsule	SCD	b41423b8-dfec-4d79-ba3c-e43a87803d85	6
2200178	Sprinkle duloxetine 40 MG Delayed Release Oral Capsule	SCD	b41423b8-dfec-4d79-ba3c-e43a87803d85	6
2200181	Sprinkle duloxetine 60 MG Delayed Release Oral Capsule	SCD	b41423b8-dfec-4d79-ba3c-e43a87803d85	6
2200174	Drizalma 20 MG Delayed Release Oral Capsule	SY	b41423b8-dfec-4d79-ba3c-e43a87803d85	6
2200177	Drizalma 30 MG Delayed Release Oral Capsule	SY	b41423b8-dfec-4d79-ba3c-e43a87803d85	6
2200180	Drizalma 40 MG Delayed Release Oral Capsule	SY	b41423b8-dfec-4d79-ba3c-e43a87803d85	6
2200183	Drizalma 60 MG Delayed Release Oral Capsule	SY	b41423b8-dfec-4d79-ba3c-e43a87803d85	6
2200168	duloxetine 20 MG Sprinkle (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule	SY	b41423b8-dfec-4d79-ba3c-e43a87803d85	6
2200175	duloxetine 30 MG Sprinkle (as duloxetine HCl 33.6 MG) Delayed Release Oral Capsule	SY	b41423b8-dfec-4d79-ba3c-e43a87803d85	6
2200178	duloxetine 40 MG Sprinkle (as duloxetine HCl 44.9 MG) Delayed Release Oral Capsule	SY	b41423b8-dfec-4d79-ba3c-e43a87803d85	6
2200181	duloxetine 60 MG Sprinkle (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule	SY	b41423b8-dfec-4d79-ba3c-e43a87803d85	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
47335-617-10	47335061710	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-617-10)	2024-06-10	0000-00-00	No	No	Current
47335-617-30	47335061730	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-617-30)	2024-06-10	0000-00-00	No	No	Current
47335-617-60	47335061760	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-617-60)	2024-06-10	0000-00-00	No	No	Current
47335-617-90	47335061790	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-617-90)	2024-06-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DRIZALMA SPRINKLE	SUN PHARMACEUTICAL INDUSTRIES, INC. \| Sun Pharmaceutical Industries Limited	2024-05-14	HUMAN PRESCRIPTION DRUG LABEL	6