Niaspan

Product NDC: 0074-3275
11-digit product format: 000743275
Labeler code: 0074
Product ID: 0074-3275_4d0c980a-6f82-417b-ad85-ff1561bb1f4b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Niacin
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: AbbVie Inc.
Application: NDA020381
Marketing category: NDA
Marketing start: 2017-09-19
Marketing end: 2022-10-21
Substance: NIACIN
Active strength: 1000 mg/1
Pharmacologic classes: Nicotinic Acid [EPC], Nicotinic Acids [CS]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0074-3275		D	Discontinued by firm		2026-08-10
excluded package	package	0074-3275	0074-3275-90	D	Discontinued by firm		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0074-3275-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0074-3275-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0074-3275-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0074-3275-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0074-3275-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0074-3275-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0074-3275-90	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0074-3275-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0074-3275-90	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0074-3275-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0074-3275-90	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0074-3275-90	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0074-3275-90	EA - Each	0074-3275	2387a4e5-2367-4fe6-a43c-6d8625a5e5e6	1	2018-01-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NIACIN	ACTIVE INGREDIENT	2679MF687A	NIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [ABBVIE INC.]	1470
NIACIN	ACTIVE MOIETY	2679MF687A	NIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [ABBVIE INC.]	1470
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [ABBVIE INC.]	1470
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [ABBVIE INC.]	1470
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [ABBVIE INC.]	1470
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [ABBVIE INC.]	1470
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [ABBVIE INC.]	1470
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [ABBVIE INC.]	1470
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [ABBVIE INC.]	1470
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	NIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [ABBVIE INC.]	1470
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [ABBVIE INC.]	1470

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2679MF687A	NIACIN	59-67-6	NIACIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0074-3275-90	00074327590	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0074-3275-90)	2017-09-19	0000-00-00	No	No	Current