Niaspan

Product NDC: 68258-6037
11-digit product format: 682586037
Labeler code: 68258
Product ID: 68258-6037_569ac5fc-e35b-4e0e-97d1-9327a1c1b511
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Niacin
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Dispensing Solutions, Inc.
Application: NDA020381
Marketing category: NDA
Marketing start: 1997-07-28
Marketing end: 0000-00-00
Substance: NIACIN
Active strength: 1000 mg/1
Pharmacologic classes: Nicotinic Acid [EPC],Nicotinic Acids [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68258-6037		I	Inactivated by FDA	2026-08-10
excluded package	package	68258-6037	68258-6037-3	I	Inactivated by FDA	2026-08-10
excluded package	package	68258-6037	68258-6037-6	I	Inactivated by FDA	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 2 · 66 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	68258-6037-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68258-6037-6	`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	68258-6037-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68258-6037-6	`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	68258-6037-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68258-6037-6	`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	68258-6037-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68258-6037-6	`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	68258-6037-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68258-6037-6	`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	68258-6037-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68258-6037-6	`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	68258-6037-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68258-6037-6	`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	68258-6037-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68258-6037-6	`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	68258-6037-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68258-6037-6	`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	68258-6037-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68258-6037-6	`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	68258-6037-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68258-6037-6	`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	68258-6037-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68258-6037-6	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68258-6037-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68258-6037-6	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68258-6037-3	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68258-6037-6	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68258-6037-3	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68258-6037-6	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68258-6037-3	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68258-6037-6	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68258-6037-3	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68258-6037-6	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68258-6037-3	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68258-6037-6	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68258-6037-3	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68258-6037-6	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68258-6037-3	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68258-6037-6	`e2bbac7714bc…`	`27bdfed8d636…`

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 Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2dae634-14ed-febf-08ee-93196433b5b7	Product name	9	20190614
0a5e5249-329b-0cff-e714-77159f193a87	Product name	1	20140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8	Product name	1	20140508
d394f843-7479-dc48-dbd3-232266c5548c	Product name	1	20140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68258-6037-3	2019-11-27	C162847	48780-1	9855d018-d949-cd31-e053-dbdaa90ab51a	These highlights do not include all the information needed to use NIASPAN ® safely and effectively. See full prescribing information for NIASPAN. NIASPAN (niacin extended-release) tablet, film coated, extended release for oral use. Initial U.S. Approval: 1997
68258-6037-6	2019-11-27	C162847	48780-1	9855d018-d949-cd31-e053-dbdaa90ab51a	These highlights do not include all the information needed to use NIASPAN ® safely and effectively. See full prescribing information for NIASPAN. NIASPAN (niacin extended-release) tablet, film coated, extended release for oral use. Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68258-6037-3	Niaspan	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30		2
68258-6037-6	Niaspan	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60		2

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 [DISPENSING SOLUTIONS, INC.]	2
NIACIN	ACTIVE MOIETY	2679MF687A	NIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	NIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68258-6037	NIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]	2	Legacy NDC, 2 package rows	20121011_414b3d30-cc7f-4f91-b21e-5090b7f5b529.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1098134	niacin 1000 MG 24HR Extended Release Oral Tablet	PSN	414b3d30-cc7f-4f91-b21e-5090b7f5b529	2
1098135	Niaspan 1000 MG 24HR Extended Release Oral Tablet	PSN	414b3d30-cc7f-4f91-b21e-5090b7f5b529	2
1098135	24 HR niacin 1000 MG Extended Release Oral Tablet [Niaspan]	SBD	414b3d30-cc7f-4f91-b21e-5090b7f5b529	2
1098134	24 HR niacin 1000 MG Extended Release Oral Tablet	SCD	414b3d30-cc7f-4f91-b21e-5090b7f5b529	2
1098135	24 HR Niaspan 1000 MG Extended Release Oral Tablet	SY	414b3d30-cc7f-4f91-b21e-5090b7f5b529	2
1098134	24 HR nicotinic acid 1000 MG Extended Release Oral Tablet	SY	414b3d30-cc7f-4f91-b21e-5090b7f5b529	2
1098135	24 HR nicotinic acid 1000 MG Extended Release Oral Tablet [Niaspan]	SY	414b3d30-cc7f-4f91-b21e-5090b7f5b529	2
1098134	24 HR vit-B3 1000 MG Extended Release Oral Tablet	SY	414b3d30-cc7f-4f91-b21e-5090b7f5b529	2
1098135	24 HR vit-B3 1000 MG Extended Release Oral Tablet [Niaspan]	SY	414b3d30-cc7f-4f91-b21e-5090b7f5b529	2
1098134	24 HR vitamin B3 1000 MG Extended Release Oral Tablet	SY	414b3d30-cc7f-4f91-b21e-5090b7f5b529	2
1098135	24 HR vitamin B3 1000 MG Extended Release Oral Tablet [Niaspan]	SY	414b3d30-cc7f-4f91-b21e-5090b7f5b529	2
1098134	niacin 1000 MG 24 HR Extended Release Oral Tablet	SY	414b3d30-cc7f-4f91-b21e-5090b7f5b529	2
1098135	Niaspan 1000 MG 24 HR Extended Release Oral Tablet	SY	414b3d30-cc7f-4f91-b21e-5090b7f5b529	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68258-6037-3	68258603703	30 in 1 BOTTLE	Historical
68258-6037-6	68258603706	60 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Niaspan	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2012-10-10	HUMAN PRESCRIPTION DRUG LABEL	2