Niacin

Product NDC: 65162-321
11-digit product format: 651620321
Labeler code: 65162
Product ID: 65162-321_0b4acd9a-d32e-4727-a9c3-3754a375840c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Niacin
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA203578
Marketing category: ANDA
Marketing start: 2015-07-27
Substance: NIACIN
Active strength: 500 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 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
A203578-001	NIACIN	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-07-24
A203578-002	NIACIN	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2015-07-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203578-001	AB
A203578-002	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 · 82 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	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203578-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203578-002	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-24	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A203578-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203578-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203578-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203578-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203578-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203578-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203578-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203578-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203578-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203578-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203578-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203578-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203578-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203578-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203578-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203578-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203578-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203578-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203578-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203578-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203578-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203578-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203578-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203578-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203578-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203578-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203578-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203578-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203578-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203578-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203578-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203578-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203578-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203578-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203578-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203578-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203578-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203578-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203578-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203578-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

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
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
6e604319-e164-4056-ab80-b78b98c519c7	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
65162-321-03	Niacin	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	10
65162-321-09	Niacin	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	10
65162-321-50	Niacin	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-321-09	EA - Each	65162-321	953f5d2c-b016-4327-b115-82b026053a16	1	2015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NIACIN	ACTIVE INGREDIENT	2679MF687A	NIACIN TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	2
NIACIN	ACTIVE MOIETY	2679MF687A	NIACIN TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NIACIN TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NIACIN TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NIACIN TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	2
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)	INACTIVE INGREDIENT	ZYD53NBL45	NIACIN TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NIACIN TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	NIACIN TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	NIACIN TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NIACIN TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-321	NIACIN TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]	9	Current NDC, Legacy NDC, 3 package rows	20241031_6e604319-e164-4056-ab80-b78b98c519c7.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Niacin	NIACIN	AvPAK	dd60fe81-3d54-4a29-9502-601be89c575e	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203578 application number: ANDA203578
Niacin	NIACIN	Amneal Pharmaceuticals LLC	6e604319-e164-4056-ab80-b78b98c519c7	2025-12-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203578 application number: ANDA203578 ndc (product): 65162-321

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	6e604319-e164-4056-ab80-b78b98c519c7	10
1098141	niacin 500 MG 24HR Extended Release Oral Tablet	PSN	6e604319-e164-4056-ab80-b78b98c519c7	10
1098134	24 HR niacin 1000 MG Extended Release Oral Tablet	SCD	6e604319-e164-4056-ab80-b78b98c519c7	10
1098141	24 HR niacin 500 MG Extended Release Oral Tablet	SCD	6e604319-e164-4056-ab80-b78b98c519c7	10
1098134	24 HR nicotinic acid 1000 MG Extended Release Oral Tablet	SY	6e604319-e164-4056-ab80-b78b98c519c7	10
1098141	24 HR nicotinic acid 500 MG Extended Release Oral Tablet	SY	6e604319-e164-4056-ab80-b78b98c519c7	10
1098134	24 HR vit-B3 1000 MG Extended Release Oral Tablet	SY	6e604319-e164-4056-ab80-b78b98c519c7	10
1098141	24 HR vit-B3 500 MG Extended Release Oral Tablet	SY	6e604319-e164-4056-ab80-b78b98c519c7	10
1098134	24 HR vitamin B3 1000 MG Extended Release Oral Tablet	SY	6e604319-e164-4056-ab80-b78b98c519c7	10
1098141	24 HR vitamin B3 500 MG Extended Release Oral Tablet	SY	6e604319-e164-4056-ab80-b78b98c519c7	10
1098134	niacin 1000 MG 24 HR Extended Release Oral Tablet	SY	6e604319-e164-4056-ab80-b78b98c519c7	10
1098141	niacin 500 MG 24 HR Extended Release Oral Tablet	SY	6e604319-e164-4056-ab80-b78b98c519c7	10
1098134	niacin 1000 MG 24HR Extended Release Oral Tablet	PSN	dd60fe81-3d54-4a29-9502-601be89c575e	8
1098141	niacin 500 MG 24HR Extended Release Oral Tablet	PSN	dd60fe81-3d54-4a29-9502-601be89c575e	8
1098134	24 HR niacin 1000 MG Extended Release Oral Tablet	SCD	dd60fe81-3d54-4a29-9502-601be89c575e	8
1098141	24 HR niacin 500 MG Extended Release Oral Tablet	SCD	dd60fe81-3d54-4a29-9502-601be89c575e	8
1098134	24 HR nicotinic acid 1000 MG Extended Release Oral Tablet	SY	dd60fe81-3d54-4a29-9502-601be89c575e	8
1098141	24 HR nicotinic acid 500 MG Extended Release Oral Tablet	SY	dd60fe81-3d54-4a29-9502-601be89c575e	8
1098134	24 HR vit-B3 1000 MG Extended Release Oral Tablet	SY	dd60fe81-3d54-4a29-9502-601be89c575e	8
1098141	24 HR vit-B3 500 MG Extended Release Oral Tablet	SY	dd60fe81-3d54-4a29-9502-601be89c575e	8
1098134	24 HR vitamin B3 1000 MG Extended Release Oral Tablet	SY	dd60fe81-3d54-4a29-9502-601be89c575e	8
1098141	24 HR vitamin B3 500 MG Extended Release Oral Tablet	SY	dd60fe81-3d54-4a29-9502-601be89c575e	8
1098134	niacin 1000 MG 24 HR Extended Release Oral Tablet	SY	dd60fe81-3d54-4a29-9502-601be89c575e	8
1098141	niacin 500 MG 24 HR Extended Release Oral Tablet	SY	dd60fe81-3d54-4a29-9502-601be89c575e	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-321-03	65162032103	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-321-03)	2015-07-27	0000-00-00	No	No	Current
65162-321-09	65162032109	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-321-09)	2015-07-27	0000-00-00	No	No	Current
65162-321-50	65162032150	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-321-50)	2015-07-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Niacin	AvPAK	2026-02-25	HUMAN PRESCRIPTION DRUG LABEL	8
Niacin	Amneal Pharmaceuticals LLC	2025-12-25	HUMAN PRESCRIPTION DRUG LABEL	10