Application 020381

Type: NDA
Sponsor: ABBVIE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NIASPAN	NIACIN	TABLET, EXTENDED RELEASE;ORAL	375MG	No	No
002	NIASPAN	NIACIN	TABLET, EXTENDED RELEASE;ORAL	500MG	Yes	No
003	NIASPAN	NIACIN	TABLET, EXTENDED RELEASE;ORAL	750MG	Yes	Yes
004	NIASPAN	NIACIN	TABLET, EXTENDED RELEASE;ORAL	1GM	Yes	Yes
005	NIASPAN TITRATION STARTER PACK	NIACIN	TABLET, EXTENDED RELEASE;ORAL	375MG;500MG;750MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020381-001	NIASPAN	NIACIN	375MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-28
N020381-002	NIASPAN	NIACIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-07-28
N020381-003	NIASPAN	NIACIN	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-07-28
N020381-004	NIASPAN	NIACIN	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-07-28
N020381-005	NIASPAN TITRATION STARTER PACK	NIACIN	375MG;500MG;750MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-28

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 6 · 205 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	N020381-001	NIASPAN	375MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020381-002	NIASPAN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020381-003	NIASPAN	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020381-004	NIASPAN	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020381-005	NIASPAN TITRATION STARTER PACK	375MG;500MG;750MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020381-001	NIASPAN	375MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020381-002	NIASPAN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020381-003	NIASPAN	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020381-004	NIASPAN	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020381-005	NIASPAN TITRATION STARTER PACK	375MG;500MG;750MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020381-001	NIASPAN	375MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020381-002	NIASPAN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020381-003	NIASPAN	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020381-004	NIASPAN	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020381-005	NIASPAN TITRATION STARTER PACK	375MG;500MG;750MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020381-001	NIASPAN	375MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020381-002	NIASPAN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020381-003	NIASPAN	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020381-004	NIASPAN	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020381-005	NIASPAN TITRATION STARTER PACK	375MG;500MG;750MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020381-001	NIASPAN	375MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020381-002	NIASPAN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020381-003	NIASPAN	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020381-004	NIASPAN	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020381-005	NIASPAN TITRATION STARTER PACK	375MG;500MG;750MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020381-001	NIASPAN	375MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020381-002	NIASPAN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020381-003	NIASPAN	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020381-004	NIASPAN	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020381-005	NIASPAN TITRATION STARTER PACK	375MG;500MG;750MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020381-001	NIASPAN	375MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020381-002	NIASPAN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020381-003	NIASPAN	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020381-004	NIASPAN	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020381-005	NIASPAN TITRATION STARTER PACK	375MG;500MG;750MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020381-001	NIASPAN	375MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020381-002	NIASPAN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020381-003	NIASPAN	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020381-004	NIASPAN	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020381-005	NIASPAN TITRATION STARTER PACK	375MG;500MG;750MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-28	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020381-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020381-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020381-004	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020381-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020381-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020381-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020381-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020381-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020381-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020381-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020381-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020381-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020381-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020381-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020381-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020381-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020381-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020381-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020381-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020381-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020381-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020381-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020381-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020381-004	AB	1	`ea99ee380514…`

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Niacin	NIACIN	Golden State Medical Supply, Inc.	8eff9205-84ac-e69d-e053-2995a90aad4b	2026-04-15	Warnings, Adverse reactions	Name fallback generic name: NIACIN
Niacin	NIACIN	AvPAK	dd60fe81-3d54-4a29-9502-601be89c575e	2026-02-25	Warnings, Adverse reactions	Name fallback generic name: NIACIN
Niacin	NIACIN	Amneal Pharmaceuticals LLC	6e604319-e164-4056-ab80-b78b98c519c7	2025-12-25	Warnings, Adverse reactions	Name fallback generic name: NIACIN
Niacin	NIACIN	Redmont Pharmaceuticals, LLC	f51f7e6d-b132-48d8-8bb1-54203472f0d8	2025-12-17	Warnings, Adverse reactions	Name fallback generic name: NIACIN
NIACIN	NIACIN	Chartwell RX, LLC	568c3a99-b6e8-48b4-bb68-867bbcefa027	2025-12-08	Warnings, Adverse reactions	Name fallback generic name: NIACIN
Niacin	NIACIN	Lannett Company, Inc.	d7b66e13-00ed-48a9-a54a-8e474cc31d54	2025-11-10	Warnings, Adverse reactions	Name fallback generic name: NIACIN
Niacin	NIACIN	Amneal Pharmaceuticals LLC	7250313b-b2ef-4736-bd25-2f29c2ac0eb9	2025-10-03	Warnings, Adverse reactions	Name fallback generic name: NIACIN
Niacin	NIACIN	Macleods Pharmaceuticals Limited	52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e	2025-01-10	Warnings, Adverse reactions	Name fallback generic name: NIACIN
NIACIN	NIACIN	Sun Pharmaceutical Industries, Inc.	8e290f96-e8c6-47fd-863f-1c9480f28d9b	2023-11-24	Warnings, Adverse reactions	Name fallback generic name: NIACIN
NIACIN	NIACIN	Lupin Pharmaceuticals, Inc.	92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b9	2023-10-06	Warnings, Adverse reactions	Name fallback generic name: NIACIN
Niacin	NIACIN	Aurobindo Pharma Limited	43233a21-3f90-4c69-bbeb-f50d5f2d35ae	2023-02-14	Warnings, Adverse reactions	Name fallback generic name: NIACIN
Niacor	NIACIN	Avondale Pharmaceuticals, LLC	bf287412-160b-403f-8eb4-57f29a475902	2021-12-23	Warnings, Adverse reactions	Name fallback generic name: NIACIN
Niacin	NIACIN	Emerald Therapeutics, LLC	5fceeb58-e54d-43c1-8abb-33feea69d663	2021-04-07	Warnings, Adverse reactions	Name fallback generic name: NIACIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0074-3265	Niaspan	Niacin	AbbVie Inc.	NDA	Current
0074-3265	Niaspan	Niacin	AbbVie Inc.	NDA	Current
0074-3265	Niaspan	Niacin	AbbVie Inc.	NDA	Current
0074-3265	Niaspan	Niacin	AbbVie Inc.	NDA	Current
0074-3265	Niaspan	Niacin	AbbVie Inc.	NDA	Current
0074-3274	Niaspan	Niacin	AbbVie Inc.	NDA	Current
0074-3274	Niaspan	Niacin	AbbVie Inc.	NDA	Current
0074-3274	Niaspan	Niacin	AbbVie Inc.	NDA	Current
0074-3274	Niaspan	Niacin	AbbVie Inc.	NDA	Current
0074-3274	Niaspan	Niacin	AbbVie Inc.	NDA	Current
0074-3275	Niaspan	Niacin	AbbVie Inc.	NDA	Current
0074-3275	Niaspan	Niacin	AbbVie Inc.	NDA	Current
0074-3275	Niaspan	Niacin	AbbVie Inc.	NDA	Current
0074-3275	Niaspan	Niacin	AbbVie Inc.	NDA	Current
0074-3275	Niaspan	Niacin	AbbVie Inc.	NDA	Current
21695-852	Niaspan	Niacin	Rebel Distributors Corp	NDA	Current
21695-865	Niaspan	Niacin	Rebel Distributors Corp	NDA	Current
50090-1536	Niaspan	Niacin	A-S Medication Solutions	NDA	Current
68151-4068	Niaspan	Niacin	Carilion Materials Management	NDA	Current
68151-4069	Niaspan	Niacin	Carilion Materials Management	NDA	Current
68258-6032	Niaspan	Niacin	Dispensing Solutions, Inc.	NDA	Current
68258-6037	Niaspan	Niacin	Dispensing Solutions, Inc.	NDA	Current
68382-201	Niacin	Niacin	Zydus Pharmaceuticals USA Inc	NDA	Current
68382-203	Niacin	Niacin	Zydus Pharmaceuticals USA Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70980	SUPPL	2022-05-04
70928	SUPPL	2022-05-03
64564	SUPPL	2020-09-11
64540	SUPPL	2020-09-10
2437	SUPPL	2015-04-28
34583	SUPPL	2015-04-27
34582	SUPPL	2013-02-26
2436	SUPPL	2013-02-25
24877	SUPPL	2010-11-12
12506	SUPPL	2010-11-12
24876	SUPPL	2010-03-03
12505	SUPPL	2010-03-03
24875	SUPPL	2009-11-12
2435	SUPPL	2009-11-12
34581	SUPPL	2009-09-21
12504	SUPPL	2009-09-21
2434	SUPPL	2009-04-01
2432	SUPPL	2008-05-30
2433	SUPPL	2008-01-09
34580	SUPPL	2007-12-27
2431	SUPPL	2007-04-09
34579	SUPPL	2006-04-12
24874	SUPPL	2006-04-12
34578	SUPPL	2005-09-15
2430	SUPPL	2005-09-15
12503	SUPPL	2005-06-10
2429	SUPPL	2005-06-10
24873	SUPPL	2004-06-10
34577	SUPPL	2003-03-05
24872	SUPPL	1999-10-28
2428	SUPPL	1999-09-13