NIACIN

Product NDC
47335-614
11-digit product format
473350614
Labeler code
47335
Product ID
47335-614_bc18daa3-5321-43bd-9d00-dabd9adac571
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NIACIN
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA201273
Marketing category
ANDA
Marketing start
2014-06-27
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201273-001NIACINNIACIN750MGTABLET, EXTENDED RELEASE / ORALABRS2014-04-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201273-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALABRS2014-04-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALABRS2014-04-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALABRS2014-04-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALABRS2014-04-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALABRS2014-04-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALABRS2014-04-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALABRS2014-04-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALABRS2014-04-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALABRS2014-04-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALABRS2014-04-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALABRS2014-04-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALABRS2014-04-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALABRS2014-04-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALABRS2014-04-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALABRS2014-04-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALABRS2014-04-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALABRS2014-04-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALAB2014-04-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALABRS2014-04-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALABRS2014-04-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALAB2014-04-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALAB2014-04-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALAB2014-04-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALAB2014-04-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALAB2014-04-233f01610625f2…
2019-09-15 20:21 UTC2019-09A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALAB2014-04-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALAB2014-04-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALABRS2014-04-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALABRS2014-04-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALABRS2014-04-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALABRS2014-04-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALABRS2014-04-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALABRS2014-04-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALABRS2014-04-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALABRS2014-04-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALABRS2014-04-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALABRS2014-04-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALABRS2014-04-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALABRS2014-04-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A201273-001NIACIN750MGTABLET, EXTENDED RELEASE / ORALABRS2014-04-23cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A201273-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201273-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201273-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201273-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201273-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201273-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201273-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201273-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201273-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201273-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201273-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201273-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201273-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201273-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201273-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201273-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201273-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201273-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201273-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201273-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201273-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A201273-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201273-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201273-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201273-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A201273-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A201273-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201273-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201273-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201273-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201273-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201273-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201273-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201273-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A201273-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A201273-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201273-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201273-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A201273-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A201273-001AB1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NIACIN750 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2679MF687AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1098134Internal RxNorm lookup
1098141Internal RxNorm lookup
1098143Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8e290f96-e8c6-47fd-863f-1c9480f28d9bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47335-614-18NIACIN1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE100022
47335-614-81NIACIN90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE9022
47335-614-83NIACIN30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3022
47335-614-88NIACIN100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-614-81EA - Each47335-6140fbe59e3-ed3b-443b-bc7a-d5dc3cab104d12014-08-01

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-614NIACIN TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]22Current NDC, Legacy NDC, 4 package rows20231125_8e290f96-e8c6-47fd-863f-1c9480f28d9b.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NIACINNIACINSun Pharmaceutical Industries, Inc.8e290f96-e8c6-47fd-863f-1c9480f28d9b2023-11-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201273
application number: ANDA201273
ndc (product): 47335-614

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098134niacin 1000 MG 24HR Extended Release Oral TabletPSN8e290f96-e8c6-47fd-863f-1c9480f28d9b22
1098141niacin 500 MG 24HR Extended Release Oral TabletPSN8e290f96-e8c6-47fd-863f-1c9480f28d9b22
1098143niacin 750 MG 24HR Extended Release Oral TabletPSN8e290f96-e8c6-47fd-863f-1c9480f28d9b22
109813424 HR niacin 1000 MG Extended Release Oral TabletSCD8e290f96-e8c6-47fd-863f-1c9480f28d9b22
109814124 HR niacin 500 MG Extended Release Oral TabletSCD8e290f96-e8c6-47fd-863f-1c9480f28d9b22
109814324 HR niacin 750 MG Extended Release Oral TabletSCD8e290f96-e8c6-47fd-863f-1c9480f28d9b22
109813424 HR nicotinic acid 1000 MG Extended Release Oral TabletSY8e290f96-e8c6-47fd-863f-1c9480f28d9b22
109814124 HR nicotinic acid 500 MG Extended Release Oral TabletSY8e290f96-e8c6-47fd-863f-1c9480f28d9b22
109814324 HR nicotinic acid 750 MG Extended Release Oral TabletSY8e290f96-e8c6-47fd-863f-1c9480f28d9b22
109813424 HR vit-B3 1000 MG Extended Release Oral TabletSY8e290f96-e8c6-47fd-863f-1c9480f28d9b22
109814124 HR vit-B3 500 MG Extended Release Oral TabletSY8e290f96-e8c6-47fd-863f-1c9480f28d9b22
109814324 HR vit-B3 750 MG Extended Release Oral TabletSY8e290f96-e8c6-47fd-863f-1c9480f28d9b22
109813424 HR vitamin B3 1000 MG Extended Release Oral TabletSY8e290f96-e8c6-47fd-863f-1c9480f28d9b22
109814124 HR vitamin B3 500 MG Extended Release Oral TabletSY8e290f96-e8c6-47fd-863f-1c9480f28d9b22
109814324 HR vitamin B3 750 MG Extended Release Oral TabletSY8e290f96-e8c6-47fd-863f-1c9480f28d9b22
1098134niacin 1000 MG 24 HR Extended Release Oral TabletSY8e290f96-e8c6-47fd-863f-1c9480f28d9b22
1098141niacin 500 MG 24 HR Extended Release Oral TabletSY8e290f96-e8c6-47fd-863f-1c9480f28d9b22
1098143niacin 750 MG 24 HR Extended Release Oral TabletSY8e290f96-e8c6-47fd-863f-1c9480f28d9b22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47335-614-18473350614181000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-614-18) 2014-06-270000-00-00NoNoCurrent
47335-614-814733506148190 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-614-81) 2014-06-270000-00-00NoNoCurrent
47335-614-834733506148330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-614-83) 2014-06-270000-00-00NoNoCurrent
47335-614-8847335061488100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-614-88) 2014-06-270000-00-00NoNoCurrent