Ranolazine

Product NDC: 72578-064
11-digit product format: 725780064
Labeler code: 72578
Product ID: 72578-064_ca6a476b-e330-4618-8661-08ac1125fc3e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ranolazine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Viona Pharmaceuticals Inc
Application: ANDA210188
Marketing category: ANDA
Marketing start: 2019-09-10
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 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
A210188-001	RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19
A210188-002	RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2019-08-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210188-001	AB
A210188-002	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 3 · 82 observed 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
2026-08-18 06:07:40	2026-07	A210188-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210188-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2019-08-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210188-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210188-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2019-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210188-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210188-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2019-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210188-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210188-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2019-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210188-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210188-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210188-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210188-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210188-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210188-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210188-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210188-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210188-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210188-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210188-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210188-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210188-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210188-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210188-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210188-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210188-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210188-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210188-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210188-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210188-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210188-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210188-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210188-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210188-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210188-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210188-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210188-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210188-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210188-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210188-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210188-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-19	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A210188-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210188-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210188-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210188-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210188-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210188-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210188-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210188-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210188-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210188-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210188-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210188-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210188-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210188-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210188-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210188-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210188-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210188-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210188-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210188-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210188-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210188-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210188-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210188-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210188-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210188-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210188-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210188-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210188-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210188-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210188-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210188-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210188-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210188-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210188-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210188-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210188-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210188-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210188-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210188-002	AB	1	`bb7c543d1eb4…`

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
A6IEZ5M406	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
616749	Internal RxNorm lookup
728231	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
00979fb3-d70f-493d-94ca-2914cbadaa9d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4367aed1-e488-b72c-d0ec-178a4e054129	Product name	9	20250624
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
ddc83a74-720a-4975-8550-c4bd979c9094	Product name	1	20221212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72578-064-01	Ranolazine	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	5
72578-064-05	Ranolazine	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500	5
72578-064-14	Ranolazine	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60	5
72578-064-30	Ranolazine	10 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	10	5
72578-064-77	Ranolazine	10 in 1 CARTON	TABLET, EXTENDED RELEASE	10	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72578-064-14	EA - Each	72578-064	5f1d2ffd-ac81-49b1-ba5f-cd782cc1626b	1	2020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72578-064	RANOLAZINE TABLET, EXTENDED RELEASE [VIONA PHARMACEUTICALS INC]	4	Current NDC, Legacy NDC, 5 package rows	20231021_00979fb3-d70f-493d-94ca-2914cbadaa9d.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ranolazine	RANOLAZINE	Zydus Lifesciences Limited	d74f3dea-7357-4e9a-be9a-2f498a44108a	2026-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210188 application number: ANDA210188
Ranolazine	RANOLAZINE	Viona Pharmaceuticals Inc	00979fb3-d70f-493d-94ca-2914cbadaa9d	2026-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210188 application number: ANDA210188 ndc (product): 72578-064
Ranolazine	RANOLAZINE	NCS HealthCare of KY, LLC dba Vangard Labs	2373687b-b9a4-496e-b89f-9754f8513fd3	2026-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210188 application number: ANDA210188
Ranolazine	RANOLAZINE	Bryant Ranch Prepack	2e678c80-1410-433b-8c48-4b210eceb0de	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210188 application number: ANDA210188

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
728231	ranolazine 1000 MG 12HR Extended Release Oral Tablet	PSN	00979fb3-d70f-493d-94ca-2914cbadaa9d	5
616749	ranolazine 500 MG 12HR Extended Release Oral Tablet	PSN	00979fb3-d70f-493d-94ca-2914cbadaa9d	5
728231	12 HR ranolazine 1000 MG Extended Release Oral Tablet	SCD	00979fb3-d70f-493d-94ca-2914cbadaa9d	5
616749	12 HR ranolazine 500 MG Extended Release Oral Tablet	SCD	00979fb3-d70f-493d-94ca-2914cbadaa9d	5
728231	ranolazine 1000 MG 12 HR Extended Release Oral Tablet	SY	00979fb3-d70f-493d-94ca-2914cbadaa9d	5
616749	ranolazine 500 MG 12 HR Extended Release Oral Tablet	SY	00979fb3-d70f-493d-94ca-2914cbadaa9d	5
616749	ranolazine 500 MG 12HR Extended Release Oral Tablet	PSN	2373687b-b9a4-496e-b89f-9754f8513fd3	1
616749	ranolazine 500 MG 12HR Extended Release Oral Tablet	PSN	2e678c80-1410-433b-8c48-4b210eceb0de	1
616749	12 HR ranolazine 500 MG Extended Release Oral Tablet	SCD	2373687b-b9a4-496e-b89f-9754f8513fd3	1
616749	12 HR ranolazine 500 MG Extended Release Oral Tablet	SCD	2e678c80-1410-433b-8c48-4b210eceb0de	1
616749	ranolazine 500 MG 12 HR Extended Release Oral Tablet	SY	2373687b-b9a4-496e-b89f-9754f8513fd3	1
616749	ranolazine 500 MG 12 HR Extended Release Oral Tablet	SY	2e678c80-1410-433b-8c48-4b210eceb0de	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72578-064-01	72578006401	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-064-01)		2019-09-10	0000-00-00	No	No	Current
72578-064-05	72578006405	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-064-05)		2019-09-10	0000-00-00	No	No	Current
72578-064-14	72578006414	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-064-14)		2019-09-10	0000-00-00	No	No	Current
72578-064-30	72578006430	10 in 1 BLISTER PACK						Historical
72578-064-77	72578006477	10 BLISTER PACK in 1 CARTON (72578-064-77) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (72578-064-30)	10 blister pack	2019-09-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ranolazine	Viona Pharmaceuticals Inc \| Zydus Lifesciences Limited	2026-01-29	HUMAN PRESCRIPTION DRUG LABEL	5
Ranolazine	NCS HealthCare of KY, LLC dba Vangard Labs \| Zydus Lifesciences Limited	2026-01-21	HUMAN PRESCRIPTION DRUG LABEL	1
Ranolazine	Bryant Ranch Prepack	2025-01-17	HUMAN PRESCRIPTION DRUG LABEL	1