NIACIN

Product NDC: 68180-221
11-digit product format: 681800221
Labeler code: 68180
Product ID: 68180-221_ab2c50ce-f3ed-46da-8a6f-d8caf1d05d58
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NIACIN
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA090860
Marketing category: ANDA
Marketing start: 2014-03-20
Marketing end: 0000-00-00
Substance: NIACIN
Active strength: 500 mg/1
Pharmacologic classes: Nicotinic Acid [EPC], Nicotinic Acids [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	68180-221		D	Discontinued by firm	2026-08-10
excluded package	package	68180-221	68180-221-01	D	Discontinued by firm	2026-08-10
excluded package	package	68180-221	68180-221-03	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 · 36 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	68180-221-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68180-221-01	`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	68180-221-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68180-221-01	`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	68180-221-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68180-221-01	`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	68180-221-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68180-221-01	`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	68180-221-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68180-221-01	`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	68180-221-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68180-221-01	`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	68180-221-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68180-221-01	`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	68180-221-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68180-221-01	`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	68180-221-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68180-221-01	`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	68180-221-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68180-221-01	`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	68180-221-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68180-221-01	`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	68180-221-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68180-221-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090860-001	NIACIN	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2014-03-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090860-001	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 2 · 41 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	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A090860-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090860-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090860-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090860-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090860-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090860-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090860-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090860-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090860-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090860-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090860-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090860-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090860-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090860-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090860-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090860-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090860-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090860-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090860-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090860-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090860-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090860-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090860-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090860-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090860-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090860-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090860-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090860-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090860-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090860-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090860-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090860-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090860-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090860-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090860-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090860-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090860-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090860-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090860-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090860-001	AB	1	`cb3db0bc1861…`

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68180-221-01	NIACIN	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		14
68180-221-03	NIACIN	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-221-01	EA - Each	68180-221	cc5ca538-9101-4fe1-9ac7-e6d44e428831	1	2014-04-03
68180-221-03	EA - Each	68180-221	29219c5c-4403-415f-8b17-c8824e990f86	1	2014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NIACIN	ACTIVE INGREDIENT	2679MF687A	NIACIN TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	8
NIACIN	ACTIVE MOIETY	2679MF687A	NIACIN TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NIACIN TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	8
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NIACIN TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	8
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NIACIN TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	8
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NIACIN TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	8
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NIACIN TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	8
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NIACIN TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	8
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NIACIN TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	8
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NIACIN TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	8
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	NIACIN TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NIACIN TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	8
NIACIN	ACTIVE INGREDIENT	2679MF687A	NIACIN TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	4
NIACIN	ACTIVE MOIETY	2679MF687A	NIACIN TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NIACIN TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NIACIN TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NIACIN TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NIACIN TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NIACIN TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NIACIN TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	4
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NIACIN TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NIACIN TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	NIACIN TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NIACIN TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68180-221	NIACIN TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	14	Legacy NDC, 2 package rows	20231031_92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b9.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NIACIN	NIACIN	Lupin Pharmaceuticals, Inc.	92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b9	2023-10-06	Warnings, Adverse reactions	Exact identifier ndc (product): 68180-221

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	92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b9	14
1098141	niacin 500 MG 24HR Extended Release Oral Tablet	PSN	92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b9	14
1098143	niacin 750 MG 24HR Extended Release Oral Tablet	PSN	92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b9	14
1098134	24 HR niacin 1000 MG Extended Release Oral Tablet	SCD	92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b9	14
1098141	24 HR niacin 500 MG Extended Release Oral Tablet	SCD	92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b9	14
1098143	24 HR niacin 750 MG Extended Release Oral Tablet	SCD	92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b9	14
1098134	24 HR nicotinic acid 1000 MG Extended Release Oral Tablet	SY	92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b9	14
1098141	24 HR nicotinic acid 500 MG Extended Release Oral Tablet	SY	92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b9	14
1098143	24 HR nicotinic acid 750 MG Extended Release Oral Tablet	SY	92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b9	14
1098134	24 HR vit-B3 1000 MG Extended Release Oral Tablet	SY	92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b9	14
1098141	24 HR vit-B3 500 MG Extended Release Oral Tablet	SY	92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b9	14
1098143	24 HR vit-B3 750 MG Extended Release Oral Tablet	SY	92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b9	14
1098134	24 HR vitamin B3 1000 MG Extended Release Oral Tablet	SY	92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b9	14
1098141	24 HR vitamin B3 500 MG Extended Release Oral Tablet	SY	92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b9	14
1098143	24 HR vitamin B3 750 MG Extended Release Oral Tablet	SY	92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b9	14
1098134	niacin 1000 MG 24 HR Extended Release Oral Tablet	SY	92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b9	14
1098141	niacin 500 MG 24 HR Extended Release Oral Tablet	SY	92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b9	14
1098143	niacin 750 MG 24 HR Extended Release Oral Tablet	SY	92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b9	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68180-221-01	68180022101	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-221-01)	2014-03-20	0000-00-00	No	No	Current
68180-221-03	68180022103	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-221-03)	2014-03-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NIACIN	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2023-10-06	HUMAN PRESCRIPTION DRUG LABEL	14
NIACIN	American Health Packaging	2021-11-17	HUMAN PRESCRIPTION DRUG LABEL	9
NIACIN	Golden State Medical Supply	2020-10-28	HUMAN PRESCRIPTION DRUG LABEL	5
NIACIN	Bryant Ranch Prepack	2020-10-16	HUMAN PRESCRIPTION DRUG LABEL	3