Niacor

Product NDC: 71740-001
11-digit product format: 717400001
Labeler code: 71740
Product ID: 71740-001_800ff22d-b10c-4cc8-920f-217a4d23563d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Niacin
Dosage form: TABLET
Route: ORAL
Labeler: Avondale Pharmaceuticals, LLC
Application: ANDA040378
Marketing category: ANDA
Marketing start: 2000-05-03
Substance: NIACIN
Active strength: 500 mg/1
Pharmacologic classes: Nicotinic Acid [EPC], Nicotinic Acids [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A040378-001	NIACOR	NIACIN	500MG	TABLET / ORAL		RS	2000-05-03

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040378-001	NIACOR	500MG	TABLET / ORAL	AA	RS	2000-05-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040378-001	NIACOR	500MG	TABLET / ORAL	AA	RS	2000-05-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040378-001	NIACOR	500MG	TABLET / ORAL	AA	RS	2000-05-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040378-001	NIACOR	500MG	TABLET / ORAL	AA	RS	2000-05-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040378-001	NIACOR	500MG	TABLET / ORAL	AA	RS	2000-05-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040378-001	NIACOR	500MG	TABLET / ORAL		RS	2000-05-03	`e64feba35796…`

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	A040378-001	AA	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A040378-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040378-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040378-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040378-001	AA	1	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: Niacor
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NIACIN	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2679MF687A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198024	Internal RxNorm lookup
311944	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
bf287412-160b-403f-8eb4-57f29a475902	Available on FDA.report

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
71740-001-10	Niacor	100 in 1 BOTTLE	TABLET	100		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71740-001-10	EA - Each	71740-001	d3114f3f-d516-427a-bf18-06e102e8f74e	1	2022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71740-001	NIACOR (NIACIN) TABLET [AVONDALE PHARMACEUTICALS, LLC]	1	Current NDC, Legacy NDC, 1 package rows	20211224_bf287412-160b-403f-8eb4-57f29a475902.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Niacin	NIACIN	Redmont Pharmaceuticals, LLC	f51f7e6d-b132-48d8-8bb1-54203472f0d8	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040378 application number: ANDA040378
Niacor	NIACIN	Avondale Pharmaceuticals, LLC	bf287412-160b-403f-8eb4-57f29a475902	2021-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040378 application number: ANDA040378 ndc (product): 71740-001
Niacin	NIACIN	Emerald Therapeutics, LLC	5fceeb58-e54d-43c1-8abb-33feea69d663	2021-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040378 application number: ANDA040378

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
198024	niacin 500 MG Oral Tablet	PSN	bf287412-160b-403f-8eb4-57f29a475902	1
311944	Niacor 500 MG Oral Tablet	PSN	bf287412-160b-403f-8eb4-57f29a475902	1
311944	niacin 500 MG Oral Tablet [Niacor]	SBD	bf287412-160b-403f-8eb4-57f29a475902	1
198024	niacin 500 MG Oral Tablet	SCD	bf287412-160b-403f-8eb4-57f29a475902	1
311944	Niacor 500 MG Oral Tablet	SY	bf287412-160b-403f-8eb4-57f29a475902	1
198024	nicotinic acid 500 MG Oral Tablet	SY	bf287412-160b-403f-8eb4-57f29a475902	1
311944	nicotinic acid 500 MG Oral Tablet [Niacor]	SY	bf287412-160b-403f-8eb4-57f29a475902	1
198024	vit-B3 500 MG Oral Tablet	SY	bf287412-160b-403f-8eb4-57f29a475902	1
311944	vit-B3 500 MG Oral Tablet [Niacor]	SY	bf287412-160b-403f-8eb4-57f29a475902	1
198024	vitamin B3 500 MG Oral Tablet	SY	bf287412-160b-403f-8eb4-57f29a475902	1
311944	vitamin B3 500 MG Oral Tablet [Niacor]	SY	bf287412-160b-403f-8eb4-57f29a475902	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71740-001-10	71740000110	100 TABLET in 1 BOTTLE (71740-001-10)	100 tablet	2021-12-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NIACOR ® (Niacin Tablets, USP) 500 mg	Avondale Pharmaceuticals, LLC	2021-12-23	HUMAN PRESCRIPTION DRUG LABEL	1