Home NDC 68180-355 RANOLAZINE
Product NDC 68180-355
11-digit product format 681800355
Labeler code 68180
Product ID 68180-355_e5f38101-deda-4a41-8c51-76edce7df3e8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name RANOLAZINE
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA201046
Marketing category ANDA
Marketing start 2019-02-27
Substance RANOLAZINE
Active strength 1000 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 2027-12-31
Current FDA listing Yes 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 date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201046-001 RANOLAZINE RANOLAZINE 500MG TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 A201046-002 RANOLAZINE RANOLAZINE 1GM TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 88 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 2026-10-15 13:18:30 2026-09 A201046-001 RANOLAZINE 500MG TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 A201046-002 RANOLAZINE 1GM TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 c2088c7a36db…2026-09-14 22:38:34 2026-08 A201046-001 RANOLAZINE 500MG TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A201046-002 RANOLAZINE 1GM TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A201046-001 RANOLAZINE 500MG TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201046-002 RANOLAZINE 1GM TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201046-001 RANOLAZINE 500MG TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201046-002 RANOLAZINE 1GM TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201046-001 RANOLAZINE 500MG TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201046-002 RANOLAZINE 1GM TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201046-001 RANOLAZINE 500MG TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201046-002 RANOLAZINE 1GM TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201046-001 RANOLAZINE 500MG TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201046-002 RANOLAZINE 1GM TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201046-001 RANOLAZINE 500MG TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201046-002 RANOLAZINE 1GM TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201046-001 RANOLAZINE 500MG TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201046-002 RANOLAZINE 1GM TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201046-001 RANOLAZINE 500MG TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201046-002 RANOLAZINE 1GM TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201046-001 RANOLAZINE 500MG TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201046-002 RANOLAZINE 1GM TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201046-001 RANOLAZINE 500MG TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201046-002 RANOLAZINE 1GM TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201046-001 RANOLAZINE 500MG TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201046-002 RANOLAZINE 1GM TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201046-001 RANOLAZINE 500MG TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201046-002 RANOLAZINE 1GM TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201046-001 RANOLAZINE 500MG TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201046-002 RANOLAZINE 1GM TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201046-001 RANOLAZINE 500MG TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201046-002 RANOLAZINE 1GM TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201046-001 RANOLAZINE 500MG TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A201046-002 RANOLAZINE 1GM TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201046-001 RANOLAZINE 500MG TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201046-002 RANOLAZINE 1GM TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201046-001 RANOLAZINE 500MG TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A201046-002 RANOLAZINE 1GM TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201046-001 RANOLAZINE 500MG TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A201046-002 RANOLAZINE 1GM TABLET, EXTENDED RELEASE / ORAL AB 2013-07-29 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 3 of 3 · 88 observed states.
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base RANOLAZINE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RANOLAZINE 1000 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination A6IEZ5M406 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 616749 Internal RxNorm lookup 728231 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 68180-355-02 RANOLAZINE 500 in 1 BOTTLE TABLET, FILM COATED, EXTENDED RE 500 11 68180-355-07 RANOLAZINE 60 in 1 BOTTLE TABLET, FILM COATED, EXTENDED RE 60 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-355 RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.] 11 Current NDC, Legacy NDC, 2 package rows 20231209_595821d7-1fbf-49a5-9c62-d78f27af39b4.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68180-355-02 68180035502 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-355-02) 2019-02-27 0000-00-00 No No Current 68180-355-07 68180035507 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-355-07) 2019-02-27 0000-00-00 No No Current