Ranolazine

Product NDC: 45963-418
11-digit product format: 459630418
Labeler code: 45963
Product ID: 45963-418_62402145-6094-4c6b-b622-ffa3fb76651d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ranolazine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA208862
Marketing category: ANDA
Marketing start: 2019-05-28
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	45963-418		D	Discontinued by firm	2026-08-17
excluded package	package	45963-418	45963-418-06	D	Discontinued by firm	2026-08-17
excluded package	package	45963-418	45963-418-50	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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45963-418-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45963-418-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45963-418-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45963-418-50	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A208862-001	RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL			2019-05-28
A208862-002	RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL			2019-05-28

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 · 84 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	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208862-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208862-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208862-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208862-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208862-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208862-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208862-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208862-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208862-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208862-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208862-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208862-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208862-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208862-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208862-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208862-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208862-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208862-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208862-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208862-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208862-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208862-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208862-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208862-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208862-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208862-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208862-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208862-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208862-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208862-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208862-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208862-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208862-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208862-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208862-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208862-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208862-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208862-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208862-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208862-002	AB	1	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4367aed1-e488-b72c-d0ec-178a4e054129	Product name	9	20250624
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
ddc83a74-720a-4975-8550-c4bd979c9094	Product name	1	20221212
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45963-418-06	Ranolazine	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60		9
45963-418-50	Ranolazine	500 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	500		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45963-418-06	EA - Each	45963-418	7835765e-2842-481c-93d5-3e71607a6a63	1	2019-06-19
45963-418-50	EA - Each	45963-418	c976134d-5ac1-499f-b60b-8171f995c58a	1	2019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45963-418	RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	8	Legacy NDC, 2 package rows	20230306_896ea7ab-8714-4e8b-a194-5b0bde318032.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
45963-418-06	45963041806	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (45963-418-06)	2019-05-28	0000-00-00	No	No	Current
45963-418-50	45963041850	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (45963-418-50)	2019-05-28	0000-00-00	No	No	Current