Ranolazine

Product NDC: 42291-774
Requested package NDC: 42291-774-60
11-digit product format: 422910774
Labeler code: 42291
Product ID: 42291-774_48750ca3-393e-d2ec-e063-6294a90ab8f2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: RANOLAZINE
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: AvKARE
Application: ANDA212781
Marketing category: ANDA
Marketing start: 2020-10-27
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A212781-001	RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2020-03-23
A212781-002	RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2020-03-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212781-001	AB
A212781-002	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 · 74 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
2026-02-19 14:30 UTC	2026-02	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 70 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	A212781-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212781-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212781-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212781-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212781-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212781-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212781-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212781-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212781-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212781-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212781-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212781-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212781-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212781-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212781-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212781-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212781-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212781-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212781-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212781-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212781-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212781-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212781-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212781-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212781-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212781-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212781-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212781-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212781-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212781-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212781-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212781-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212781-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212781-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212781-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212781-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212781-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212781-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212781-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212781-002	AB	1	`87673890dc5c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ranolazine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RANOLAZINE	1000 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
b2a8dc3e-a880-5241-e053-2995a90a933a	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
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
42291-774-60	Ranolazine	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-774	RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [AVKARE]	6	Current NDC, Legacy NDC, 1 package rows	20240328_b2a8dc3e-a880-5241-e053-2995a90a933a.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ranolazine	RANOLAZINE	SunGen Pharma LLC	f3c09979-a44a-4197-97d2-29a207b6fc73	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212781 application number: ANDA212781
Ranolazine	RANOLAZINE	AvKARE	b2a8dc3e-a880-5241-e053-2995a90a933a	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212781 application number: ANDA212781 ndc (package): 42291-774-60 ndc (product): 42291-774 ndc11 (package): 42291077460
Ranolazine	RANOLAZINE	Aphena Pharma Solutions - Tennessee, LLC	abb32182-46ba-49d2-b2ac-13de2ecf802d	2024-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212781 application number: ANDA212781

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	b2a8dc3e-a880-5241-e053-2995a90a933a	7
616749	ranolazine 500 MG 12HR Extended Release Oral Tablet	PSN	b2a8dc3e-a880-5241-e053-2995a90a933a	7
728231	12 HR ranolazine 1000 MG Extended Release Oral Tablet	SCD	b2a8dc3e-a880-5241-e053-2995a90a933a	7
616749	12 HR ranolazine 500 MG Extended Release Oral Tablet	SCD	b2a8dc3e-a880-5241-e053-2995a90a933a	7
728231	ranolazine 1000 MG 12 HR Extended Release Oral Tablet	SY	b2a8dc3e-a880-5241-e053-2995a90a933a	7
616749	ranolazine 500 MG 12 HR Extended Release Oral Tablet	SY	b2a8dc3e-a880-5241-e053-2995a90a933a	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42291-774-60	42291077460	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-774-60)	2020-10-27	0000-00-00	No	No	Current