Ranolazine

Product NDC: 68462-319
11-digit product format: 684620319
Labeler code: 68462
Product ID: 68462-319_891a4c1d-ed0c-4002-87d9-e395df0386d1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: RANOLAZINE
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA211082
Marketing category: ANDA
Marketing start: 2019-07-05
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
A211082-001	RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-07-05
A211082-002	RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2019-07-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211082-001	AB
A211082-002	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 · 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	A211082-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211082-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211082-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211082-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211082-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211082-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211082-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211082-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211082-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211082-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211082-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211082-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211082-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211082-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211082-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211082-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211082-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211082-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211082-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211082-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211082-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211082-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211082-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211082-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211082-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211082-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211082-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211082-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211082-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211082-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211082-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211082-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211082-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211082-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211082-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211082-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211082-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211082-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211082-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211082-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-07-05	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A211082-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211082-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211082-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211082-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211082-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211082-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211082-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211082-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211082-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211082-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211082-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211082-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211082-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211082-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211082-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211082-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211082-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211082-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211082-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211082-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211082-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211082-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211082-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211082-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211082-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211082-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211082-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211082-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211082-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211082-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211082-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211082-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211082-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211082-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211082-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211082-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211082-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211082-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211082-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211082-002	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
0cf58732-c242-49b0-8e3f-248778b4458d	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
ddc83a74-720a-4975-8550-c4bd979c9094	Product name	1	20221212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68462-319-05	Ranolazine	500 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	500		5
68462-319-60	Ranolazine	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-319-60	EA - Each	68462-319	e320eaaa-a1ee-4968-ac76-64d7c65a46e8	1	2019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-319	RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]	4	Current NDC, Legacy NDC, 2 package rows	20240104_0cf58732-c242-49b0-8e3f-248778b4458d.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ranolazine	RANOLAZINE	Glenmark Pharmaceuticals Inc., USA	0cf58732-c242-49b0-8e3f-248778b4458d	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211082 application number: ANDA211082 ndc (product): 68462-319

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	0cf58732-c242-49b0-8e3f-248778b4458d	5
616749	ranolazine 500 MG 12HR Extended Release Oral Tablet	PSN	0cf58732-c242-49b0-8e3f-248778b4458d	5
728231	12 HR ranolazine 1000 MG Extended Release Oral Tablet	SCD	0cf58732-c242-49b0-8e3f-248778b4458d	5
616749	12 HR ranolazine 500 MG Extended Release Oral Tablet	SCD	0cf58732-c242-49b0-8e3f-248778b4458d	5
728231	ranolazine 1000 MG 12 HR Extended Release Oral Tablet	SY	0cf58732-c242-49b0-8e3f-248778b4458d	5
616749	ranolazine 500 MG 12 HR Extended Release Oral Tablet	SY	0cf58732-c242-49b0-8e3f-248778b4458d	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-319-05	68462031905	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-319-05)	2019-07-05	0000-00-00	No	No	Current
68462-319-60	68462031960	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-319-60)	2019-07-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ranolazine	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2026-01-23	HUMAN PRESCRIPTION DRUG LABEL	5