Ranolazine

Product NDC: 43975-289
11-digit product format: 439750289
Labeler code: 43975
Product ID: 43975-289_5d37b8e0-3e6d-4ea3-9d98-4d6faa1c7f02
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ranolazine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: ANI Pharmaceuticals, Inc.
Application: ANDA210482
Marketing category: ANDA
Marketing start: 2020-01-23
Marketing end: 2021-11-30
Substance: RANOLAZINE
Active strength: 1 g/1
Pharmacologic classes: Anti-anginal [EPC],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	43975-289		D	Discontinued by firm	2026-08-17
excluded package	package	43975-289	43975-289-06	D	Discontinued by firm	2026-08-17
excluded package	package	43975-289	43975-289-50	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 · 42 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	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43975-289-06	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43975-289-50	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43975-289-06	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43975-289-50	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43975-289-06	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43975-289-50	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43975-289-06	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43975-289-50	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43975-289-06	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43975-289-50	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43975-289-06	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43975-289-50	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43975-289-06	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43975-289-50	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43975-289-06	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43975-289-50	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43975-289-06	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43975-289-50	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43975-289-06	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43975-289-50	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43975-289-06	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43975-289-50	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43975-289-06	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43975-289-50	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	43975-289-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	43975-289-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	43975-289-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`263afe128892…`	`91768de4ddbe…`

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
A210482-001	RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL			2019-10-29
A210482-002	RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL			2019-10-29

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 · 80 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	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A210482-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210482-002	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A210482-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210482-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210482-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A210482-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210482-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A210482-002	AB	1	`3f01610625f2…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43975-289-06	EA - Each	43975-289	480cb17a-7d96-4b2a-8ed7-d1131c1257d7	1	2020-01-03

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
43975-289-06	43975028906	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (43975-289-06)	2020-01-23	2021-11-30	No	No	Current