Ranolazine

Product NDC
59651-009
11-digit product format
596510009
Labeler code
59651
Product ID
59651-009_ee3c2383-a36a-4abe-9764-89f817798f28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranolazine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA209081
Marketing category
ANDA
Marketing start
2022-12-23
Substance
RANOLAZINE
Active strength
500 mg/1
Pharmacologic classes
Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct59651-009UNFINISHEDActive or certified unfinished drug listing2026-08-17
unfinished packagepackage59651-00959651-009-15UNFINISHEDActive or certified unfinished drug listing2026-08-17

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 · 28 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05unfinished productproducta6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage59651-009-15a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-26unfinished productproduct1d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage59651-009-151d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14unfinished productproduct390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage59651-009-15390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31unfinished productproducte30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage59651-009-15e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28unfinished productproductbbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage59651-009-15bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductf268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage59651-009-15f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31unfinished productproductf764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage59651-009-15f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-17unfinished productproduct68b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage59651-009-1568b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproduct05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage59651-009-1505c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-08unfinished productproduct48b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage59651-009-1548b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-08unfinished productproduct27f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage59651-009-1527f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-09unfinished productproduct8d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage59651-009-158d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished productproductd1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage59651-009-15d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-14unfinished productproduct50b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage59651-009-1550b4072663b7…eae3003ed65e…

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
A209081-001RANOLAZINERANOLAZINE500MGTABLET, EXTENDED RELEASE / ORALAB2022-12-23
A209081-002RANOLAZINERANOLAZINE1GMTABLET, EXTENDED RELEASE / ORALAB2022-12-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209081-001AB
A209081-002AB

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 · 50 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A209081-001RANOLAZINE500MGTABLET, EXTENDED RELEASE / ORALAB2022-12-23caaa826d4ba7…
2026-08-18 06:07:402026-07A209081-002RANOLAZINE1GMTABLET, EXTENDED RELEASE / ORALAB2022-12-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209081-001RANOLAZINE500MGTABLET, EXTENDED RELEASE / ORALAB2022-12-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209081-002RANOLAZINE1GMTABLET, EXTENDED RELEASE / ORALAB2022-12-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209081-001RANOLAZINE500MGTABLET, EXTENDED RELEASE / ORALAB2022-12-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209081-002RANOLAZINE1GMTABLET, EXTENDED RELEASE / ORALAB2022-12-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A209081-001RANOLAZINE500MGTABLET, EXTENDED RELEASE / ORALAB2022-12-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209081-002RANOLAZINE1GMTABLET, EXTENDED RELEASE / ORALAB2022-12-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209081-001RANOLAZINE500MGTABLET, EXTENDED RELEASE / ORALAB2022-12-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209081-002RANOLAZINE1GMTABLET, EXTENDED RELEASE / ORALAB2022-12-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209081-001RANOLAZINE500MGTABLET, EXTENDED RELEASE / ORALAB2022-12-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209081-002RANOLAZINE1GMTABLET, EXTENDED RELEASE / ORALAB2022-12-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209081-001RANOLAZINE500MGTABLET, EXTENDED RELEASE / ORALAB2022-12-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209081-002RANOLAZINE1GMTABLET, EXTENDED RELEASE / ORALAB2022-12-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209081-001RANOLAZINE500MGTABLET, EXTENDED RELEASE / ORALAB2022-12-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209081-002RANOLAZINE1GMTABLET, EXTENDED RELEASE / ORALAB2022-12-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209081-001RANOLAZINE500MGTABLET, EXTENDED RELEASE / ORALAB2022-12-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209081-002RANOLAZINE1GMTABLET, EXTENDED RELEASE / ORALAB2022-12-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209081-001RANOLAZINE500MGTABLET, EXTENDED RELEASE / ORALAB2022-12-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209081-002RANOLAZINE1GMTABLET, EXTENDED RELEASE / ORALAB2022-12-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209081-001RANOLAZINE500MGTABLET, EXTENDED RELEASE / ORALAB2022-12-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A209081-002RANOLAZINE1GMTABLET, EXTENDED RELEASE / ORALAB2022-12-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209081-001RANOLAZINE500MGTABLET, EXTENDED RELEASE / ORALAB2022-12-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209081-002RANOLAZINE1GMTABLET, EXTENDED RELEASE / ORALAB2022-12-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209081-001RANOLAZINE500MGTABLET, EXTENDED RELEASE / ORALAB2022-12-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209081-002RANOLAZINE1GMTABLET, EXTENDED RELEASE / ORALAB2022-12-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209081-001RANOLAZINE500MGTABLET, EXTENDED RELEASE / ORALAB2022-12-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209081-002RANOLAZINE1GMTABLET, EXTENDED RELEASE / ORALAB2022-12-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209081-001RANOLAZINE500MGTABLET, EXTENDED RELEASE / ORALAB2022-12-238072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209081-002RANOLAZINE1GMTABLET, EXTENDED RELEASE / ORALAB2022-12-238072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209081-001RANOLAZINE500MGTABLET, EXTENDED RELEASE / ORALAB2022-12-236a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209081-002RANOLAZINE1GMTABLET, EXTENDED RELEASE / ORALAB2022-12-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209081-001RANOLAZINE500MGTABLET, EXTENDED RELEASE / ORALAB2022-12-231c564ffb4f44…
2024-02-18 07:12 UTC2024-02A209081-002RANOLAZINE1GMTABLET, EXTENDED RELEASE / ORALAB2022-12-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209081-001RANOLAZINE500MGTABLET, EXTENDED RELEASE / ORALAB2022-12-23ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A209081-002RANOLAZINE1GMTABLET, EXTENDED RELEASE / ORALAB2022-12-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209081-001RANOLAZINE500MGTABLET, EXTENDED RELEASE / ORALAB2022-12-23a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209081-002RANOLAZINE1GMTABLET, EXTENDED RELEASE / ORALAB2022-12-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209081-001RANOLAZINE500MGTABLET, EXTENDED RELEASE / ORALAB2022-12-239b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209081-002RANOLAZINE1GMTABLET, EXTENDED RELEASE / ORALAB2022-12-239b2671bbb829…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A209081-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209081-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209081-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209081-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209081-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209081-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209081-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209081-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209081-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209081-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209081-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209081-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209081-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209081-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209081-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209081-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209081-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209081-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209081-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209081-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209081-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209081-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209081-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209081-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209081-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209081-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209081-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209081-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209081-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209081-002AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209081-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209081-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209081-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A209081-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209081-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A209081-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209081-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209081-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209081-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209081-002AB19b2671bbb829…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RANOLAZINE500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
A6IEZ5M406Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
616749Internal RxNorm lookup
728231Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
49873158-5c0a-41da-86a2-369ef6b0cbc8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4367aed1-e488-b72c-d0ec-178a4e054129Product name920250624
ddc83a74-720a-4975-8550-c4bd979c9094Product name120221212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-009-18Ranolazine180 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1802
59651-009-60Ranolazine60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE602
59651-009-99Ranolazine1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-009-60EA - Each59651-0095ace4ae7-6540-4b59-993d-f5b4eb838fd712023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-009RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]2Current NDC, Legacy NDC, 3 package rows20240216_49873158-5c0a-41da-86a2-369ef6b0cbc8.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
RanolazineRANOLAZINEAurobindo Pharma Limited49873158-5c0a-41da-86a2-369ef6b0cbc82024-02-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209081
application number: ANDA209081
ndc (product): 59651-009

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728231ranolazine 1000 MG 12HR Extended Release Oral TabletPSN49873158-5c0a-41da-86a2-369ef6b0cbc82
616749ranolazine 500 MG 12HR Extended Release Oral TabletPSN49873158-5c0a-41da-86a2-369ef6b0cbc82
72823112 HR ranolazine 1000 MG Extended Release Oral TabletSCD49873158-5c0a-41da-86a2-369ef6b0cbc82
61674912 HR ranolazine 500 MG Extended Release Oral TabletSCD49873158-5c0a-41da-86a2-369ef6b0cbc82
728231ranolazine 1000 MG 12 HR Extended Release Oral TabletSY49873158-5c0a-41da-86a2-369ef6b0cbc82
616749ranolazine 500 MG 12 HR Extended Release Oral TabletSY49873158-5c0a-41da-86a2-369ef6b0cbc82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59651-009-15596510009151500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BAG (59651-009-15)23-DEC-22Current
59651-009-1859651000918180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-009-18) 2022-12-230000-00-00NoNoCurrent
59651-009-605965100096060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-009-60) 2022-12-230000-00-00NoNoCurrent
59651-009-99596510009991000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-009-99) 2022-12-230000-00-00NoNoCurrent