Home NDC 60290-055 Ranolazine
Product NDC 60290-055
11-digit product format 602900055
Labeler code 60290
Product ID 60290-055_5e7d2b80-75af-d86d-e063-6294a90a6365
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 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 2027-12-31
Current FDA listing Yes 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 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 2026-10-15 13:18:30 2026-09 A214551-001 RANOLAZINE 500MG TABLET, EXTENDED RELEASE / ORAL AB 2026-08-05 c2088c7a36db…2026-10-15 13:18:30 2026-09 A214551-002 RANOLAZINE 1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-08-05 c2088c7a36db…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 500 mg/1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 60290-055-01 60290005501 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (60290-055-01) 2026-08-10 No No Current 60290-055-03 60290005503 6 BLISTER PACK in 1 CARTON (60290-055-03) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 6 blister pack 2026-08-10 No No Current