Ranexa

Product NDC
43353-880
Requested package NDC
43353-880-83
11-digit product format
433530880
Labeler code
43353
Product ID
43353-880_d39e6df1-44b6-46a3-9da7-250f6a589b01
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RANOLAZINE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA021526
Marketing category
NDA
Marketing start
2006-01-27
Marketing end
0000-00-00
Substance
RANOLAZINE
Active strength
500 mg/1
Pharmacologic classes
Anti-anginal [EPC],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage43353-88043353-880-83DDiscontinued by firm2026-08-17

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43353-88043353-880-83DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43353-88043353-880-83DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021526-001RANEXARANOLAZINE1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2007-02-12
N021526-002RANEXARANOLAZINE500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-01-27

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021526-001RANEXA1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2007-02-12caaa826d4ba7…
2026-08-18 06:07:402026-07N021526-002RANEXA500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-01-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021526-001RANEXA1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2007-02-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021526-002RANEXA500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-01-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021526-001RANEXA1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2007-02-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021526-002RANEXA500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-01-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N021526-001RANEXA1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2007-02-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021526-002RANEXA500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-01-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021526-001RANEXA1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2007-02-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021526-002RANEXA500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-01-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021526-001RANEXA1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2007-02-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021526-002RANEXA500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-01-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021526-001RANEXA1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2007-02-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021526-002RANEXA500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-01-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021526-001RANEXA1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2007-02-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021526-002RANEXA500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-01-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021526-001RANEXA1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2007-02-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021526-002RANEXA500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-01-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021526-001RANEXA1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2007-02-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021526-002RANEXA500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-01-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021526-001RANEXA1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2007-02-12d06236e962d9…
2024-10-29 15:01 UTC2024-10N021526-002RANEXA500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-01-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021526-001RANEXA1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2007-02-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021526-002RANEXA500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-01-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021526-001RANEXA1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2007-02-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021526-002RANEXA500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-01-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021526-001RANEXA1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2007-02-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021526-002RANEXA500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-01-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021526-001RANEXA1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2007-02-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021526-002RANEXA500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2006-01-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021526-001RANEXA1GMTABLET, EXTENDED RELEASE / ORALABRLD, RS2007-02-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021526-002RANEXA500MGTABLET, EXTENDED RELEASE / ORALABRLD2006-01-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021526-001RANEXA1GMTABLET, EXTENDED RELEASE / ORALABRLD, RS2007-02-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021526-002RANEXA500MGTABLET, EXTENDED RELEASE / ORALABRLD2006-01-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021526-001RANEXA1GMTABLET, EXTENDED RELEASE / ORALABRLD, RS2007-02-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021526-002RANEXA500MGTABLET, EXTENDED RELEASE / ORALABRLD2006-01-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021526-001RANEXA1GMTABLET, EXTENDED RELEASE / ORALABRLD, RS2007-02-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021526-002RANEXA500MGTABLET, EXTENDED RELEASE / ORALABRLD2006-01-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021526-001RANEXA1GMTABLET, EXTENDED RELEASE / ORALABRLD, RS2007-02-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021526-002RANEXA500MGTABLET, EXTENDED RELEASE / ORALABRLD2006-01-27bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021526-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021526-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021526-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021526-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021526-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021526-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021526-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021526-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021526-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021526-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021526-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N021526-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021526-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021526-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N021526-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021526-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021526-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021526-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021526-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021526-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021526-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N021526-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N021526-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N021526-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021526-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N021526-002AB1ea99ee380514…
2023-01-26 05:58 UTC2023-01N021526-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N021526-002AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021526-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021526-002AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021526-001AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N021526-002AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021526-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09N021526-002AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021526-001AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021526-002AB1cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021526-00163036072019-05-27U-70574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021526-00163690622019-05-27Drug product, Delist requested74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021526-00164794962019-05-27U-70574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021526-00165039112019-05-27Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021526-00165250572019-05-27U-70574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021526-00165628262019-05-27U-70574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021526-00166173282019-05-27Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021526-00166208142019-05-27U-70574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021526-00168527242019-05-27U-70574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021526-00168642582019-05-27U-70574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021526-00263036072019-05-27U-70574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021526-00263690622019-05-27Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021526-00264794962019-05-27U-70574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021526-00265039112019-05-27Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021526-00265250572019-05-27U-70574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021526-00265628262019-05-27U-70574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021526-00266173282019-05-27Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021526-00266208142019-05-27U-70574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021526-00268527242019-05-27U-70574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021526-00268642582019-05-27U-70574a2ff9319b5…
2019-12-14 00:12 UTC2019-12N021526-00163036072019-05-27U-7053f01610625f2…
2019-12-14 00:12 UTC2019-12N021526-00163690622019-05-27Drug product, Delist requested3f01610625f2…
2019-12-14 00:12 UTC2019-12N021526-00164794962019-05-27U-7053f01610625f2…
2019-12-14 00:12 UTC2019-12N021526-00165039112019-05-27Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021526-00165250572019-05-27U-7053f01610625f2…
2019-12-14 00:12 UTC2019-12N021526-00165628262019-05-27U-7053f01610625f2…
2019-12-14 00:12 UTC2019-12N021526-00166173282019-05-27Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021526-00166208142019-05-27U-7053f01610625f2…
2019-12-14 00:12 UTC2019-12N021526-00168527242019-05-27U-7053f01610625f2…
2019-12-14 00:12 UTC2019-12N021526-00168642582019-05-27U-7053f01610625f2…
2019-12-14 00:12 UTC2019-12N021526-00263036072019-05-27U-7053f01610625f2…
2019-12-14 00:12 UTC2019-12N021526-00263690622019-05-27Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021526-00264794962019-05-27U-7053f01610625f2…
2019-12-14 00:12 UTC2019-12N021526-00265039112019-05-27Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021526-00265250572019-05-27U-7053f01610625f2…
2019-12-14 00:12 UTC2019-12N021526-00265628262019-05-27U-7053f01610625f2…
2019-12-14 00:12 UTC2019-12N021526-00266173282019-05-27Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021526-00266208142019-05-27U-7053f01610625f2…
2019-12-14 00:12 UTC2019-12N021526-00268527242019-05-27U-7053f01610625f2…
2019-12-14 00:12 UTC2019-12N021526-00268642582019-05-27U-7053f01610625f2…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-880-83EA - Each43353-8808a79ad48-3ce2-4af5-b9a1-3631b6b7ee1b12016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-880RANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20160803_4299062a-b208-4e08-93ec-a05894541c07.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-880-83433530880833600 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-880-83) 2016-01-060000-00-00NoNoCurrent