Niacin

Product NDC: 70752-296
11-digit product format: 707520296
Labeler code: 70752
Product ID: 70752-296_db58af90-4e3b-4cb6-aa5d-1b381d532cf9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Niacin
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: QUAGEN PHARMACEUTICALS LLC
Application: ANDA203899
Marketing category: ANDA
Marketing start: 2026-08-06
Substance: NIACIN
Active strength: 1000 mg/1
Pharmacologic classes: Nicotinic Acid [EPC], Nicotinic Acids [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A203899-001	NIACIN	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-16
A203899-002	NIACIN	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203899-001	AB
A203899-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A203899-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203899-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203899-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203899-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203899-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203899-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203899-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203899-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203899-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203899-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203899-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203899-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203899-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203899-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203899-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203899-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203899-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203899-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203899-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203899-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203899-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203899-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203899-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203899-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203899-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203899-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203899-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203899-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203899-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203899-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203899-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203899-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203899-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203899-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203899-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203899-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203899-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203899-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203899-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203899-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2017-06-16	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203899-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203899-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203899-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203899-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203899-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203899-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203899-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203899-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203899-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203899-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203899-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203899-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203899-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203899-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203899-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203899-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203899-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203899-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203899-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203899-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203899-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203899-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203899-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203899-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203899-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203899-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203899-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203899-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203899-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203899-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203899-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203899-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203899-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203899-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203899-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203899-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203899-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203899-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203899-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203899-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Niacin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NIACIN	1000 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
1098134	Internal RxNorm lookup
1098141	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
249e27ac-e1e7-42dc-84f6-cd32fd1d9dee	Available on FDA.report

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Niacin	NIACIN	Golden State Medical Supply, Inc.	8eff9205-84ac-e69d-e053-2995a90aad4b	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203899 application number: ANDA203899
Niacin	NIACIN	QUAGEN PHARMACEUTICALS LLC	249e27ac-e1e7-42dc-84f6-cd32fd1d9dee	2025-12-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203899 application number: ANDA203899 ndc (product): 70752-296
NIACIN	NIACIN	Chartwell RX, LLC	568c3a99-b6e8-48b4-bb68-867bbcefa027	2025-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203899 application number: ANDA203899
Niacin	NIACIN	Lannett Company, Inc.	d7b66e13-00ed-48a9-a54a-8e474cc31d54	2025-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203899 application number: ANDA203899

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2679MF687A	NIACIN	59-67-6	NIACIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70752-296-09	70752029609	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70752-296-09)	2026-08-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Niacin	QUAGEN PHARMACEUTICALS LLC \| Lannett Company, Inc.	2025-12-25	HUMAN PRESCRIPTION DRUG LABEL	1