Niacin

Product NDC: 65162-322
11-digit product format: 651620322
Labeler code: 65162
Product ID: 65162-322_b75c66ae-a08b-439c-b526-7897a38bc3a8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Niacin
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA204178
Marketing category: ANDA
Marketing start: 2015-12-11
Substance: NIACIN
Active strength: 750 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 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
A204178-001	NIACIN	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-12-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204178-001	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	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204178-001	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-11	`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	A204178-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204178-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204178-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204178-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204178-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204178-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204178-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204178-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204178-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204178-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204178-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204178-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204178-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204178-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204178-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204178-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204178-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204178-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204178-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204178-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204178-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204178-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204178-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204178-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204178-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204178-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204178-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204178-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204178-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204178-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204178-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204178-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204178-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204178-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204178-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204178-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204178-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204178-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204178-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204178-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NIACIN	750 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1098143	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
7250313b-b2ef-4736-bd25-2f29c2ac0eb9	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	SPL version
65162-322-03	Niacin	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30	14
65162-322-09	Niacin	90 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	90	14
65162-322-50	Niacin	500 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	500	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-322-09	EA - Each	65162-322	23651ed5-381e-4f5c-a7cd-764c124245bd	1	2016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-322	NIACIN TABLET, FILM COATED, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]	13	Current NDC, Legacy NDC, 3 package rows	20241031_7250313b-b2ef-4736-bd25-2f29c2ac0eb9.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	Amneal Pharmaceuticals LLC	7250313b-b2ef-4736-bd25-2f29c2ac0eb9	2025-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204178 application number: ANDA204178 ndc (product): 65162-322

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
1098143	niacin 750 MG 24HR Extended Release Oral Tablet	PSN	7250313b-b2ef-4736-bd25-2f29c2ac0eb9	14
1098143	24 HR niacin 750 MG Extended Release Oral Tablet	SCD	7250313b-b2ef-4736-bd25-2f29c2ac0eb9	14
1098143	24 HR nicotinic acid 750 MG Extended Release Oral Tablet	SY	7250313b-b2ef-4736-bd25-2f29c2ac0eb9	14
1098143	24 HR vit-B3 750 MG Extended Release Oral Tablet	SY	7250313b-b2ef-4736-bd25-2f29c2ac0eb9	14
1098143	24 HR vitamin B3 750 MG Extended Release Oral Tablet	SY	7250313b-b2ef-4736-bd25-2f29c2ac0eb9	14
1098143	niacin 750 MG 24 HR Extended Release Oral Tablet	SY	7250313b-b2ef-4736-bd25-2f29c2ac0eb9	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-322-03	65162032203	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-322-03)	2015-12-11	0000-00-00	No	No	Current
65162-322-09	65162032209	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-322-09)	2015-12-11	0000-00-00	No	No	Current
65162-322-50	65162032250	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-322-50)	2015-12-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Niacin	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals Private Limited	2025-10-03	HUMAN PRESCRIPTION DRUG LABEL	14