Ranolazine

Product NDC: 65162-379
11-digit product format: 651620379
Labeler code: 65162
Product ID: 65162-379_47217efb-8ecf-4bc8-9445-9ee9d87157d1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ranolazine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA207690
Marketing category: ANDA
Marketing start: 2021-03-12
Marketing end: 0000-00-00
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: 2023-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	65162-379		D	Discontinued by firm	2026-10-05
excluded package	package	65162-379	65162-379-06	D	Discontinued by firm	2026-10-05
excluded package	package	65162-379	65162-379-18	D	Discontinued by firm	2026-10-05
excluded package	package	65162-379	65162-379-50	D	Discontinued by firm	2026-10-05

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
A207690-001	RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL			2021-03-11
A207690-002	RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL			2021-03-11

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 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A207690-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207690-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207690-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207690-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207690-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207690-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207690-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207690-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207690-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207690-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207690-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207690-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207690-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207690-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207690-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207690-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207690-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207690-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207690-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207690-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207690-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207690-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207690-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207690-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207690-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207690-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207690-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207690-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207690-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207690-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207690-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207690-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207690-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207690-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207690-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207690-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207690-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207690-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207690-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207690-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	2021-03-11	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207690-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207690-002	AB	1	`87673890dc5c…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-379	RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]	12	Legacy NDC	20241031_a3f284f3-ca10-484c-964b-f8abc3acc1cd.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
A6IEZ5M406	RANOLAZINE	95635-55-5	RANOLAZINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-379-06	65162037906	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-379-06)	2021-03-12	0000-00-00	No	No	Current
65162-379-18	65162037918	180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-379-18)	2021-03-12	0000-00-00	No	No	Current
65162-379-50	65162037950	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-379-50)	2021-03-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ranolazine	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals of New York, LLC	2020-05-30	HUMAN PRESCRIPTION DRUG LABEL	12