Niacin

Product NDC: 59651-019
11-digit product format: 596510019
Labeler code: 59651
Product ID: 59651-019_8539231f-47da-402e-b05d-16c45cc3670c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Niacin
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA209236
Marketing category: ANDA
Marketing start: 2018-02-01
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A209236-001	NIACIN	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01
A209236-002	NIACIN	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01
A209236-003	NIACIN	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A209236-001	AB
A209236-002	AB
A209236-003	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 4 · 123 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	A209236-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209236-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209236-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209236-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209236-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209236-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209236-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209236-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209236-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209236-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209236-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209236-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209236-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209236-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209236-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209236-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209236-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209236-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209236-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209236-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209236-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209236-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209236-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209236-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209236-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209236-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209236-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209236-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209236-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209236-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209236-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209236-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209236-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209236-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209236-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209236-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209236-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209236-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209236-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209236-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-02-01	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A209236-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209236-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209236-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209236-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209236-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209236-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209236-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209236-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209236-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209236-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209236-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209236-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209236-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209236-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209236-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209236-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209236-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209236-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209236-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209236-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209236-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209236-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209236-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209236-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209236-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209236-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209236-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209236-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209236-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209236-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209236-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209236-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209236-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209236-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209236-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209236-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209236-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209236-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209236-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209236-001	AB	1	`8072bd15b7f6…`

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1098134	Internal RxNorm lookup
1098141	Internal RxNorm lookup
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
43233a21-3f90-4c69-bbeb-f50d5f2d35ae	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
59651-019-05	Niacin	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500	7
59651-019-18	Niacin	180 in 1 BOTTLE	TABLET, EXTENDED RELEASE	180	7
59651-019-90	Niacin	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59651-019-18	EA - Each	59651-019	55afebb5-b69c-4325-a243-eff223b29a7f	1	2018-04-19
59651-019-90	EA - Each	59651-019	1cfa875e-a77a-4495-8b5f-c7fa91f5a3ac	1	2018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59651-019	NIACIN TABLET, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	7	Current NDC, Legacy NDC, 3 package rows	20230219_43233a21-3f90-4c69-bbeb-f50d5f2d35ae.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	Aurobindo Pharma Limited	43233a21-3f90-4c69-bbeb-f50d5f2d35ae	2023-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209236 application number: ANDA209236 ndc (product): 59651-019

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	43233a21-3f90-4c69-bbeb-f50d5f2d35ae	7
1098141	niacin 500 MG 24HR Extended Release Oral Tablet	PSN	43233a21-3f90-4c69-bbeb-f50d5f2d35ae	7
1098143	niacin 750 MG 24HR Extended Release Oral Tablet	PSN	43233a21-3f90-4c69-bbeb-f50d5f2d35ae	7
1098134	24 HR niacin 1000 MG Extended Release Oral Tablet	SCD	43233a21-3f90-4c69-bbeb-f50d5f2d35ae	7
1098141	24 HR niacin 500 MG Extended Release Oral Tablet	SCD	43233a21-3f90-4c69-bbeb-f50d5f2d35ae	7
1098143	24 HR niacin 750 MG Extended Release Oral Tablet	SCD	43233a21-3f90-4c69-bbeb-f50d5f2d35ae	7
1098134	24 HR nicotinic acid 1000 MG Extended Release Oral Tablet	SY	43233a21-3f90-4c69-bbeb-f50d5f2d35ae	7
1098141	24 HR nicotinic acid 500 MG Extended Release Oral Tablet	SY	43233a21-3f90-4c69-bbeb-f50d5f2d35ae	7
1098143	24 HR nicotinic acid 750 MG Extended Release Oral Tablet	SY	43233a21-3f90-4c69-bbeb-f50d5f2d35ae	7
1098134	24 HR vit-B3 1000 MG Extended Release Oral Tablet	SY	43233a21-3f90-4c69-bbeb-f50d5f2d35ae	7
1098141	24 HR vit-B3 500 MG Extended Release Oral Tablet	SY	43233a21-3f90-4c69-bbeb-f50d5f2d35ae	7
1098143	24 HR vit-B3 750 MG Extended Release Oral Tablet	SY	43233a21-3f90-4c69-bbeb-f50d5f2d35ae	7
1098134	24 HR vitamin B3 1000 MG Extended Release Oral Tablet	SY	43233a21-3f90-4c69-bbeb-f50d5f2d35ae	7
1098141	24 HR vitamin B3 500 MG Extended Release Oral Tablet	SY	43233a21-3f90-4c69-bbeb-f50d5f2d35ae	7
1098143	24 HR vitamin B3 750 MG Extended Release Oral Tablet	SY	43233a21-3f90-4c69-bbeb-f50d5f2d35ae	7
1098134	niacin 1000 MG 24 HR Extended Release Oral Tablet	SY	43233a21-3f90-4c69-bbeb-f50d5f2d35ae	7
1098141	niacin 500 MG 24 HR Extended Release Oral Tablet	SY	43233a21-3f90-4c69-bbeb-f50d5f2d35ae	7
1098143	niacin 750 MG 24 HR Extended Release Oral Tablet	SY	43233a21-3f90-4c69-bbeb-f50d5f2d35ae	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
59651-019-05	59651001905	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-019-05)	2018-02-01	0000-00-00	No	No	Current
59651-019-18	59651001918	180 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-019-18)	2018-02-01	0000-00-00	No	No	Current
59651-019-90	59651001990	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-019-90)	2018-02-01	0000-00-00	No	No	Current