RANOLAZINE

Product NDC: 72319-021
11-digit product format: 723190021
Labeler code: 72319
Product ID: 72319-021_163908d8-6b41-4e68-b14c-76faa57c7ac0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: RANOLAZINE
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: i3 Pharmaceuticals, LLC
Application: ANDA213517
Marketing category: ANDA
Marketing start: 2022-06-15
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: 2026-12-31
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
A213517-001	RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2022-04-27
A213517-002	RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2022-04-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213517-001	AB
A213517-002	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 · 58 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	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`9b2671bbb829…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 58 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	A213517-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213517-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213517-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213517-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213517-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213517-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213517-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213517-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213517-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213517-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213517-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213517-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213517-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213517-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213517-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213517-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213517-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213517-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213517-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213517-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213517-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213517-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213517-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213517-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213517-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213517-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213517-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213517-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213517-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213517-002	AB	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213517-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213517-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213517-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213517-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213517-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213517-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213517-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213517-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213517-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213517-002	AB	1	`9b2671bbb829…`

Additional Listing Data#

Finished product: Yes
Brand name base: RANOLAZINE
Listing expiration: 2026-12-31

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
de3185bf-448a-15f7-e053-2995a90a9a2e	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
72319-021-02	RANOLAZINE	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	60		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72319-021-02	EA - Each	72319-021	a0500bb1-673c-40ce-b1a1-55208c171367	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72319-021	RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [I3 PHARMACEUTICALS, LLC]	4	Current NDC, Legacy NDC, 1 package rows	20221019_de3185bf-448a-15f7-e053-2995a90a9a2e.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	A2A Integrated Pharmaceuticals	9fb62878-c76a-4be2-99be-962ce2956af2	2025-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213517 application number: ANDA213517
RANOLAZINE	RANOLAZINE	Bryant Ranch Prepack	9199e28a-ddbe-46a4-ab26-9b08034289be	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213517 application number: ANDA213517
RANOLAZINE	RANOLAZINE	i3 Pharmaceuticals, LLC	de3185bf-448a-15f7-e053-2995a90a9a2e	2022-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213517 application number: ANDA213517 ndc (product): 72319-021

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	de3185bf-448a-15f7-e053-2995a90a9a2e	4
616749	ranolazine 500 MG 12HR Extended Release Oral Tablet	PSN	de3185bf-448a-15f7-e053-2995a90a9a2e	4
728231	12 HR ranolazine 1000 MG Extended Release Oral Tablet	SCD	de3185bf-448a-15f7-e053-2995a90a9a2e	4
616749	12 HR ranolazine 500 MG Extended Release Oral Tablet	SCD	de3185bf-448a-15f7-e053-2995a90a9a2e	4
728231	ranolazine 1000 MG 12 HR Extended Release Oral Tablet	SY	de3185bf-448a-15f7-e053-2995a90a9a2e	4
616749	ranolazine 500 MG 12 HR Extended Release Oral Tablet	SY	de3185bf-448a-15f7-e053-2995a90a9a2e	4
616749	ranolazine 500 MG 12HR Extended Release Oral Tablet	PSN	9199e28a-ddbe-46a4-ab26-9b08034289be	1
616749	12 HR ranolazine 500 MG Extended Release Oral Tablet	SCD	9199e28a-ddbe-46a4-ab26-9b08034289be	1
616749	ranolazine 500 MG 12 HR Extended Release Oral Tablet	SY	9199e28a-ddbe-46a4-ab26-9b08034289be	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72319-021-02	72319002102	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72319-021-02)	2022-06-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
RANOLAZINE	Bryant Ranch Prepack	2025-01-23	HUMAN PRESCRIPTION DRUG LABEL	1
RANOLAZINE	i3 Pharmaceuticals, LLC	2022-05-04	HUMAN PRESCRIPTION DRUG LABEL	4