Home NDC 60290-056 Ranolazine
Product NDC 60290-056
11-digit product format 602900056
Labeler code 60290
Product ID 60290-056_587551c1-2bad-d0a9-e063-6394a90aa672
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ranolazine
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Umedica Laboratories USA Inc.
Application ANDA214551
Marketing category ANDA
Marketing start 2026-08-10
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A214551-001 RANOLAZINE RANOLAZINE 500MG TABLET, EXTENDED RELEASE / ORAL AB 2026-08-05 A214551-002 RANOLAZINE RANOLAZINE 1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-08-05
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.
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 2026-09-14 22:38:34 2026-08 A214551-001 RANOLAZINE 500MG TABLET, EXTENDED RELEASE / ORAL AB 2026-08-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214551-002 RANOLAZINE 1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-08-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214551-001 RANOLAZINE 500MG TABLET, EXTENDED RELEASE / ORAL AB 2026-08-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214551-002 RANOLAZINE 1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-08-05 caaa826d4ba7…
Observed Orange Book normalized TE 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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 60290-056-01 60290005601 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (60290-056-01) 2026-08-10 No No Current 60290-056-03 60290005603 6 BLISTER PACK in 1 CARTON (60290-056-03) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 6 blister pack 2026-08-10 No No Current