Niacin

Product NDC: 10135-614
11-digit product format: 101350614
Labeler code: 10135
Product ID: 10135-614_33e9a963-426b-48fe-ac2a-34ec6e2151bd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Niacin
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Marlex Pharmaceuticals Inc
Application: ANDA203578
Marketing category: ANDA
Marketing start: 2016-02-01
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: 2019-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	10135-614		I	Inactivated by FDA	2026-08-10
excluded package	package	10135-614	10135-614-05	I	Inactivated by FDA	2026-08-10
excluded package	package	10135-614	10135-614-30	I	Inactivated by FDA	2026-08-10
excluded package	package	10135-614	10135-614-90	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 · 84 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	10135-614-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10135-614-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10135-614-30	`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	10135-614-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10135-614-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10135-614-30	`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	10135-614-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10135-614-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10135-614-30	`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	10135-614-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10135-614-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10135-614-30	`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	10135-614-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10135-614-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10135-614-30	`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	10135-614-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10135-614-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10135-614-30	`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	10135-614-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10135-614-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10135-614-30	`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	10135-614-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10135-614-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10135-614-30	`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	10135-614-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10135-614-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10135-614-30	`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	10135-614-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10135-614-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10135-614-30	`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	10135-614-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10135-614-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10135-614-30	`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	10135-614-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10135-614-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10135-614-30	`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	10135-614-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10135-614-90	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10135-614-30	`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	10135-614-05	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10135-614-90	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10135-614-30	`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	10135-614-05	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10135-614-90	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10135-614-30	`1332a3947898…`	`d4bfe170f9cd…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203578-001	NIACIN	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-07-24
A203578-002	NIACIN	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2015-07-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A203578-001	AB
A203578-002	AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203578-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203578-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203578-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203578-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203578-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203578-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203578-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203578-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203578-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203578-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203578-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203578-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203578-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203578-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203578-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203578-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203578-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203578-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203578-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203578-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203578-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203578-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203578-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203578-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203578-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203578-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203578-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203578-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203578-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203578-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203578-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203578-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203578-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203578-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203578-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203578-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203578-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203578-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203578-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203578-002	AB	1	`782e0a99824c…`

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
10135-614-05	2020-01-31	C162847	48780-1	9d75b9cf-f3aa-f424-e053-dadaa90a57ce	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, film-coated, for oral use. Initial U.S. Approval: 1997
10135-614-30	2020-01-31	C162847	48780-1	9d75b9cf-f3aa-f424-e053-dadaa90a57ce	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, film-coated, for oral use. Initial U.S. Approval: 1997
10135-614-90	2020-01-31	C162847	48780-1	9d75b9cf-f3aa-f424-e053-dadaa90a57ce	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, film-coated, for oral use. Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10135-614-05	Niacin	500 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	500	1
10135-614-30	Niacin	30 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	30	1
10135-614-90	Niacin	90 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10135-614-90	EA - Each	10135-614	c742dac5-0334-4b8f-bc05-1276e87f188a	1	2016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10135-614	NIACIN TABLET, EXTENDED RELEASE [MARLEX PHARMACEUTICALS INC]	1	Legacy NDC, 3 package rows	20160406_e80aadb4-0533-4887-8dbb-a75f0c739942.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Niacin	NIACIN	AvPAK	dd60fe81-3d54-4a29-9502-601be89c575e	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203578 application number: ANDA203578
Niacin	NIACIN	Amneal Pharmaceuticals LLC	6e604319-e164-4056-ab80-b78b98c519c7	2025-12-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203578 application number: ANDA203578

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	e80aadb4-0533-4887-8dbb-a75f0c739942	1
1098141	niacin 500 MG 24HR Extended Release Oral Tablet	PSN	e80aadb4-0533-4887-8dbb-a75f0c739942	1
1098143	niacin 750 MG 24HR Extended Release Oral Tablet	PSN	e80aadb4-0533-4887-8dbb-a75f0c739942	1
1098134	24 HR niacin 1000 MG Extended Release Oral Tablet	SCD	e80aadb4-0533-4887-8dbb-a75f0c739942	1
1098141	24 HR niacin 500 MG Extended Release Oral Tablet	SCD	e80aadb4-0533-4887-8dbb-a75f0c739942	1
1098143	24 HR niacin 750 MG Extended Release Oral Tablet	SCD	e80aadb4-0533-4887-8dbb-a75f0c739942	1
1098134	24 HR nicotinic acid 1000 MG Extended Release Oral Tablet	SY	e80aadb4-0533-4887-8dbb-a75f0c739942	1
1098141	24 HR nicotinic acid 500 MG Extended Release Oral Tablet	SY	e80aadb4-0533-4887-8dbb-a75f0c739942	1
1098143	24 HR nicotinic acid 750 MG Extended Release Oral Tablet	SY	e80aadb4-0533-4887-8dbb-a75f0c739942	1
1098134	24 HR vit-B3 1000 MG Extended Release Oral Tablet	SY	e80aadb4-0533-4887-8dbb-a75f0c739942	1
1098141	24 HR vit-B3 500 MG Extended Release Oral Tablet	SY	e80aadb4-0533-4887-8dbb-a75f0c739942	1
1098143	24 HR vit-B3 750 MG Extended Release Oral Tablet	SY	e80aadb4-0533-4887-8dbb-a75f0c739942	1
1098134	24 HR vitamin B3 1000 MG Extended Release Oral Tablet	SY	e80aadb4-0533-4887-8dbb-a75f0c739942	1
1098141	24 HR vitamin B3 500 MG Extended Release Oral Tablet	SY	e80aadb4-0533-4887-8dbb-a75f0c739942	1
1098143	24 HR vitamin B3 750 MG Extended Release Oral Tablet	SY	e80aadb4-0533-4887-8dbb-a75f0c739942	1
1098134	niacin 1000 MG 24 HR Extended Release Oral Tablet	SY	e80aadb4-0533-4887-8dbb-a75f0c739942	1
1098141	niacin 500 MG 24 HR Extended Release Oral Tablet	SY	e80aadb4-0533-4887-8dbb-a75f0c739942	1
1098143	niacin 750 MG 24 HR Extended Release Oral Tablet	SY	e80aadb4-0533-4887-8dbb-a75f0c739942	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10135-614-05	10135061405	500 in 1 BOTTLE, PLASTIC	Historical
10135-614-30	10135061430	30 in 1 BOTTLE, PLASTIC	Historical
10135-614-90	10135061490	90 in 1 BOTTLE, PLASTIC	Historical