Ranolazine

Product NDC: 42385-963
11-digit product format: 423850963
Labeler code: 42385
Product ID: 42385-963_dae26a01-bfd7-0432-e053-2995a90a88dd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ranolazine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Laurus Generics Inc.
Application: ANDA214035
Marketing category: ANDA
Marketing start: 2022-01-19
Marketing end: 0000-00-00
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: 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42385-963		D	Discontinued by firm		2026-08-17
excluded package	package	42385-963	42385-963-60	D	Discontinued by firm		2026-08-17

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42385-963-60	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42385-963-60	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42385-963-60	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42385-963-60	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A214035-001	RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2022-01-19
A214035-002	RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2022-01-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214035-001	AB
A214035-002	AB

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 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A214035-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214035-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214035-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214035-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214035-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214035-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214035-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214035-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214035-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214035-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214035-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214035-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214035-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214035-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214035-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214035-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214035-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214035-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214035-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214035-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214035-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214035-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214035-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214035-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214035-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214035-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214035-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214035-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214035-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214035-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214035-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214035-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214035-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214035-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214035-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214035-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214035-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214035-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214035-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214035-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-01-19	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A214035-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214035-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214035-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214035-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214035-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214035-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214035-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214035-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214035-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214035-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214035-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214035-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214035-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214035-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214035-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214035-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214035-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214035-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214035-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214035-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214035-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214035-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214035-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214035-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214035-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214035-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214035-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214035-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214035-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214035-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214035-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214035-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214035-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214035-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214035-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214035-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214035-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214035-002	AB	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214035-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214035-002	AB	1	`6a51e52b5d6a…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42385-963-60	EA - Each	42385-963	c88e2e13-aef1-47d3-a729-434a0b61e75e	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42385-963	RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [LAURUS GENERICS INC.]	7	Legacy NDC	20250121_3e265b25-81a6-4348-98d7-08df2b5c3b62.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ranolazine	RANOLAZINE	Torrent Pharma, Inc.	d2454377-2abd-4d9f-85f1-12f1adbb10e5	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214035 application number: ANDA214035

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
42385-963-60	42385096360	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42385-963-60)	2022-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ranolazine	Laurus Generics Inc. \| VKT Pharma Private Limited	2025-01-17	HUMAN PRESCRIPTION DRUG LABEL	7