NIACIN

Product NDC
68180-223
Requested package NDC
68180-223-01
11-digit product format
681800223
Labeler code
68180
Product ID
68180-223_ab2c50ce-f3ed-46da-8a6f-d8caf1d05d58
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NIACIN
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA090446
Marketing category
ANDA
Marketing start
2014-03-20
Marketing end
0000-00-00
Substance
NIACIN
Active strength
1000 mg/1
Pharmacologic classes
Nicotinic Acid [EPC], Nicotinic Acids [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68180-22368180-223-01DDiscontinued by firm2026-08-10

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
A090446-001NIACINNIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090446-001AB

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 UTC2026-02A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-203f01610625f2…
2019-09-15 20:21 UTC2019-09A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090446-001NIACIN1GMTABLET, EXTENDED RELEASE / ORALAB2014-03-20cb3db0bc1861…

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 UTC2026-02A090446-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090446-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090446-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090446-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090446-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090446-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090446-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090446-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090446-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090446-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090446-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090446-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090446-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090446-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090446-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090446-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090446-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090446-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090446-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090446-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090446-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090446-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090446-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090446-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090446-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090446-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090446-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090446-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090446-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090446-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090446-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090446-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090446-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090446-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090446-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090446-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090446-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090446-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090446-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090446-001AB1cb3db0bc1861…

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
68180-223-01NIACIN100 in 1 BOTTLETABLET, EXTENDED RELEASE10014
68180-223-03NIACIN1000 in 1 BOTTLETABLET, EXTENDED RELEASE100014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-223-01EA - Each68180-223e32281f4-9023-4ac1-b342-3528a1f73ed112014-04-03
68180-223-03EA - Each68180-2238427b788-0c32-4f0e-9d9c-613b4ded0d5212014-08-01

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-223NIACIN TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]14Legacy NDC, 2 package rows20231031_92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b9.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
NIACINNIACINLupin Pharmaceuticals, Inc.92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b92023-10-06Warnings, Adverse reactionsExact identifier
ndc (package): 68180-223-01
ndc (product): 68180-223
ndc11 (package): 68180022301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098134niacin 1000 MG 24HR Extended Release Oral TabletPSN92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
1098141niacin 500 MG 24HR Extended Release Oral TabletPSN92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
1098143niacin 750 MG 24HR Extended Release Oral TabletPSN92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
109813424 HR niacin 1000 MG Extended Release Oral TabletSCD92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
109814124 HR niacin 500 MG Extended Release Oral TabletSCD92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
109814324 HR niacin 750 MG Extended Release Oral TabletSCD92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
109813424 HR nicotinic acid 1000 MG Extended Release Oral TabletSY92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
109814124 HR nicotinic acid 500 MG Extended Release Oral TabletSY92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
109814324 HR nicotinic acid 750 MG Extended Release Oral TabletSY92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
109813424 HR vit-B3 1000 MG Extended Release Oral TabletSY92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
109814124 HR vit-B3 500 MG Extended Release Oral TabletSY92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
109814324 HR vit-B3 750 MG Extended Release Oral TabletSY92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
109813424 HR vitamin B3 1000 MG Extended Release Oral TabletSY92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
109814124 HR vitamin B3 500 MG Extended Release Oral TabletSY92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
109814324 HR vitamin B3 750 MG Extended Release Oral TabletSY92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
1098134niacin 1000 MG 24 HR Extended Release Oral TabletSY92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
1098141niacin 500 MG 24 HR Extended Release Oral TabletSY92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
1098143niacin 750 MG 24 HR Extended Release Oral TabletSY92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-223-0168180022301100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-223-01) 2014-03-200000-00-00NoNoCurrent