Niacin

Product NDC: 33342-189
Requested package NDC: 33342-189-11
11-digit product format: 333420189
Labeler code: 33342
Product ID: 33342-189_2b583ae0-4d24-bd44-e063-6394a90a0ced
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Niacin
Dosage form: TABLET
Route: ORAL
Labeler: Macleods Pharmaceuticals Limited
Application: ANDA204934
Marketing category: ANDA
Marketing start: 2022-03-03
Substance: NIACIN
Active strength: 1000 mg/1
Pharmacologic classes: Nicotinic Acid [EPC], Nicotinic Acids [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33342-189	33342-189-11	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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

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
A204934-001	NIACIN	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2022-03-03
A204934-002	NIACIN	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2022-03-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204934-001	AB
A204934-002	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 2 · 62 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	A204934-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204934-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204934-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204934-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204934-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204934-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204934-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204934-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204934-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204934-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204934-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204934-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204934-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204934-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204934-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204934-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204934-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204934-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204934-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204934-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204934-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204934-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204934-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204934-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204934-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204934-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204934-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204934-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204934-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204934-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204934-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204934-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204934-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204934-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204934-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204934-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204934-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204934-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204934-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204934-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-03	`ea1830bbd6c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 62 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	A204934-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204934-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204934-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204934-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204934-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204934-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204934-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204934-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204934-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204934-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204934-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204934-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204934-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204934-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204934-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204934-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204934-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204934-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204934-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204934-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204934-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204934-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204934-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204934-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204934-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204934-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204934-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204934-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204934-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204934-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204934-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204934-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204934-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204934-002	AB	1	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204934-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204934-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204934-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204934-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204934-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204934-002	AB	1	`ea1830bbd6c7…`

Additional Listing Data#

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

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
52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e	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
33342-189-10	Niacin	90 in 1 BOTTLE	TABLET	90		4
33342-189-11	Niacin	100 in 1 BOTTLE	TABLET	100		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33342-189-10	EA - Each	33342-189	cda67b77-02b5-4b58-bd9d-cfe45b26d984	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33342-189	NIACIN (NIACIN) TABLET [MACLEODS PHARMACEUTICALS LIMITED]	4	Current NDC, Legacy NDC, 2 package rows	20250112_52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e.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	Macleods Pharmaceuticals Limited	52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e	2025-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204934 application number: ANDA204934 ndc (package): 33342-189-11 ndc (product): 33342-189 ndc11 (package): 33342018911

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	52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e	4
1098141	niacin 500 MG 24HR Extended Release Oral Tablet	PSN	52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e	4
1098134	24 HR niacin 1000 MG Extended Release Oral Tablet	SCD	52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e	4
1098141	24 HR niacin 500 MG Extended Release Oral Tablet	SCD	52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e	4
1098134	24 HR nicotinic acid 1000 MG Extended Release Oral Tablet	SY	52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e	4
1098141	24 HR nicotinic acid 500 MG Extended Release Oral Tablet	SY	52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e	4
1098134	24 HR vit-B3 1000 MG Extended Release Oral Tablet	SY	52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e	4
1098141	24 HR vit-B3 500 MG Extended Release Oral Tablet	SY	52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e	4
1098134	24 HR vitamin B3 1000 MG Extended Release Oral Tablet	SY	52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e	4
1098141	24 HR vitamin B3 500 MG Extended Release Oral Tablet	SY	52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e	4
1098134	niacin 1000 MG 24 HR Extended Release Oral Tablet	SY	52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e	4
1098141	niacin 500 MG 24 HR Extended Release Oral Tablet	SY	52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
33342-189-11	33342018911	100 TABLET in 1 BOTTLE (33342-189-11)	100 tablet	2022-03-03	0000-00-00	No	No	Current