Ranolazine

Product NDC: 50268-723
11-digit product format: 502680723
Labeler code: 50268
Product ID: 50268-723_47fc05ed-b529-4ae7-e063-6394a90ae1dd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ranolazine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: AvPAK
Application: ANDA209953
Marketing category: ANDA
Marketing start: 2022-09-20
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 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
A209953-001	RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2020-11-30
A209953-002	RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2020-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209953-001	AB
A209953-002	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
2026-08-18 06:07:40	2026-07	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 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	A209953-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209953-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209953-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209953-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209953-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209953-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209953-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209953-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209953-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209953-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209953-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209953-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209953-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209953-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209953-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209953-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209953-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209953-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209953-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209953-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209953-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209953-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209953-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209953-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209953-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209953-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209953-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209953-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209953-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209953-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209953-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209953-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209953-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209953-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209953-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209953-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209953-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209953-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209953-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209953-002	AB	1	`782e0a99824c…`

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
e92350e8-5b0b-95d3-e053-2995a90a959b	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
50268-723-11	Ranolazine	1 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	1		2
50268-723-13	Ranolazine	30 in 1 BOX	TABLET, FILM COATED, EXTENDED RE	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-723-11	EA - Each	50268-723	0dbd0240-19ad-40fe-9726-2d19c5e50475	1	2022-10-06
50268-723-13	EA - Each	50268-723	1a1aa596-34a7-4193-a100-5883d4c2f89a	1	2022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50268-723	RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]	1	Current NDC, Legacy NDC, 2 package rows	20220922_e92350e8-5b0b-95d3-e053-2995a90a959b.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	Major Pharmaceuticals	6166c40c-4fbe-47c4-92e4-2dc5d3567a86	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209953 application number: ANDA209953
Ranolazine	RANOLAZINE	AvPAK	e92350e8-5b0b-95d3-e053-2995a90a959b	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209953 application number: ANDA209953 ndc (product): 50268-723
Ranolazine	RANOLAZINE	Ascend Laboratories, LLC	5b254a8e-db88-49be-bb48-e6d2847f8ab3	2025-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209953 application number: ANDA209953

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	e92350e8-5b0b-95d3-e053-2995a90a959b	2
616749	ranolazine 500 MG 12HR Extended Release Oral Tablet	PSN	e92350e8-5b0b-95d3-e053-2995a90a959b	2
728231	12 HR ranolazine 1000 MG Extended Release Oral Tablet	SCD	e92350e8-5b0b-95d3-e053-2995a90a959b	2
616749	12 HR ranolazine 500 MG Extended Release Oral Tablet	SCD	e92350e8-5b0b-95d3-e053-2995a90a959b	2
728231	ranolazine 1000 MG 12 HR Extended Release Oral Tablet	SY	e92350e8-5b0b-95d3-e053-2995a90a959b	2
616749	ranolazine 500 MG 12 HR Extended Release Oral Tablet	SY	e92350e8-5b0b-95d3-e053-2995a90a959b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50268-723-11	50268072311	1 in 1 BLISTER PACK						Historical
50268-723-13	50268072313	30 BLISTER PACK in 1 BOX (50268-723-13) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (50268-723-11)	30 blister pack	2022-09-20	0000-00-00	No	No	Current