Home NDC 72919-420 Niacin
Product NDC 72919-420
11-digit product format 729190420
Labeler code 72919
Product ID 72919-420_f80225f4-fe62-4807-8369-7cf33e0161dd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Niacin
Dosage form TABLET
Route ORAL
Labeler Emerald Therapeutics, LLC
Application ANDA040378
Marketing category ANDA
Marketing start 2000-05-03
Substance NIACIN
Active strength 500 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040378-001 NIACOR NIACIN 500MG TABLET / ORAL RS 2000-05-03
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040378-001 NIACOR 500MG TABLET / ORAL AA RS 2000-05-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040378-001 NIACOR 500MG TABLET / ORAL AA RS 2000-05-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040378-001 NIACOR 500MG TABLET / ORAL AA RS 2000-05-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040378-001 NIACOR 500MG TABLET / ORAL AA RS 2000-05-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040378-001 NIACOR 500MG TABLET / ORAL AA RS 2000-05-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040378-001 NIACOR 500MG TABLET / ORAL RS 2000-05-03 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Niacin
Listing expiration 2026-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198024 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72919-420-90 Niacin 90 in 1 BOTTLE TABLET 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72919-420 NIACIN TABLET [EMERALD THERAPEUTICS, LLC] 1 Current NDC, Legacy NDC, 1 package rows 20210408_5fceeb58-e54d-43c1-8abb-33feea69d663.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72919-420-90 72919042090 90 TABLET in 1 BOTTLE (72919-420-90) 90 tablet 2021-03-31 0000-00-00 No No Current