niacin

Product NDC: 59746-387
Requested package NDC: 59746-387-01
11-digit product format: 597460387
Labeler code: 59746
Product ID: 59746-387_b8acc369-aca2-47b6-98eb-9f087775d8b5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Niacin
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Jubilant Cadista Pharmaceuticals Inc.
Application: ANDA209156
Marketing category: ANDA
Marketing start: 2018-05-14
Marketing end: 0000-00-00
Substance: NIACIN
Active strength: 1000 mg/1
Pharmacologic classes: Nicotinic Acid [EPC],Nicotinic Acids [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	59746-387	59746-387-01	D	Discontinued by firm		2026-08-03

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A209156-001	NIACIN	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-14
A209156-002	NIACIN	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-14
A209156-003	NIACIN	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	2018-05-14

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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209156-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209156-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209156-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209156-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209156-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209156-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209156-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209156-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209156-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209156-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209156-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209156-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209156-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209156-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209156-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209156-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209156-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209156-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209156-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209156-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209156-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209156-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209156-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209156-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209156-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209156-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209156-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209156-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209156-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209156-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209156-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209156-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209156-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209156-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209156-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209156-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209156-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209156-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209156-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209156-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-14	`8072bd15b7f6…`

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	A209156-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209156-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209156-003	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209156-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209156-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209156-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209156-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209156-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209156-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209156-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209156-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209156-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209156-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209156-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209156-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209156-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209156-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209156-003	AB	1	`3f01610625f2…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
59746-387-01	2025-12-31	These highlights do not include all the information needed to use NIACIN EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for NIACIN EXTENDED-RELEASE TABLETS. NIACIN extended-release tablets, for oral use. Initial U.S. Approval: 1997
59746-387-30	2025-12-31	These highlights do not include all the information needed to use NIACIN EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for NIACIN EXTENDED-RELEASE TABLETS. NIACIN extended-release tablets, for oral use. Initial U.S. Approval: 1997
59746-387-67	2025-12-31	These highlights do not include all the information needed to use NIACIN EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for NIACIN EXTENDED-RELEASE TABLETS. NIACIN extended-release tablets, for oral use. Initial U.S. Approval: 1997
59746-387-90	2025-12-31	These highlights do not include all the information needed to use NIACIN EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for NIACIN EXTENDED-RELEASE TABLETS. NIACIN extended-release tablets, for oral use. Initial U.S. Approval: 1997
59746-387-01	2023-01-30	These highlights do not include all the information needed to use NIACIN EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for NIACIN EXTENDED-RELEASE TABLETS. NIACIN extended-release tablets, for oral use. Initial U.S. Approval: 1997
59746-387-30	2023-01-30	These highlights do not include all the information needed to use NIACIN EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for NIACIN EXTENDED-RELEASE TABLETS. NIACIN extended-release tablets, for oral use. Initial U.S. Approval: 1997
59746-387-67	2023-01-30	These highlights do not include all the information needed to use NIACIN EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for NIACIN EXTENDED-RELEASE TABLETS. NIACIN extended-release tablets, for oral use. Initial U.S. Approval: 1997
59746-387-90	2023-01-30	These highlights do not include all the information needed to use NIACIN EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for NIACIN EXTENDED-RELEASE TABLETS. NIACIN extended-release tablets, for oral use. Initial U.S. Approval: 1997

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59746-387	NIACIN TABLET, EXTENDED RELEASE [JUBILANT CADISTA PHARMACEUTICALS INC.]	4	Legacy NDC	20190704_cf57262f-2314-31a3-e478-d927a91a11b9.zip

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
59746-387-01	59746038701	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59746-387-01)	2018-05-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
niacin	Jubilant Cadista Pharmaceuticals Inc. \| Jubilant Generics Limited	2019-06-20	HUMAN PRESCRIPTION DRUG LABEL	4