Fluvastatin Sodium

Product NDC: 0527-2580
11-digit product format: 005272580
Labeler code: 0527
Product ID: 0527-2580_4d56c57e-1d38-e010-e063-6294a90a8c83
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluvastatin Sodium
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Lannett Company, Inc.
Application: ANDA209397
Marketing category: ANDA
Marketing start: 2021-05-07
Substance: FLUVASTATIN SODIUM
Active strength: 80 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209397-001	FLUVASTATIN SODIUM	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2021-04-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209397-001	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.

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	A209397-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209397-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209397-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209397-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209397-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209397-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209397-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209397-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209397-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209397-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209397-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209397-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209397-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209397-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209397-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209397-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209397-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-26	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209397-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209397-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-26	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209397-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209397-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209397-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209397-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209397-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209397-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209397-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209397-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209397-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209397-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209397-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209397-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209397-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-26	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209397-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-26	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209397-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209397-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209397-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209397-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209397-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209397-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209397-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209397-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209397-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209397-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209397-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209397-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209397-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209397-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209397-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209397-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209397-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209397-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209397-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209397-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209397-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209397-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209397-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209397-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209397-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209397-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209397-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209397-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209397-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209397-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209397-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209397-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209397-001	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUVASTATIN SODIUM	80 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
PYF7O1FV7F	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
360507	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
3565bfd3-ef9f-456d-b4be-a294a7a0f01c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
22ca7ed4-2e69-d74c-9eff-803d6d02a7be	Product name	4	20211021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0527-2580-32	Fluvastatin Sodium	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	30		13
0527-2580-37	Fluvastatin Sodium	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	100		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0527-2580-32	EA - Each	0527-2580	5f6cf9e7-9ef8-4181-a0c5-02cfa4e027fe	1	2021-07-15
0527-2580-37	EA - Each	0527-2580	47571e01-bef5-48e7-a736-0a78fa94fa3f	1	2022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0527-2580	FLUVASTATIN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [LANNETT COMPANY, INC.]	11	Current NDC, Legacy NDC, 2 package rows	20240719_3565bfd3-ef9f-456d-b4be-a294a7a0f01c.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
Fluvastatin Sodium	FLUVASTATIN SODIUM	Lannett Company, Inc.	3565bfd3-ef9f-456d-b4be-a294a7a0f01c	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209397 application number: ANDA209397 ndc (product): 0527-2580

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
PYF7O1FV7F	FLUVASTATIN SODIUM	93957-55-2	FLUVASTATIN SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
360507	fluvastatin sodium 80 MG 24HR Extended Release Oral Tablet	PSN	3565bfd3-ef9f-456d-b4be-a294a7a0f01c	13
360507	24 HR fluvastatin 80 MG Extended Release Oral Tablet	SCD	3565bfd3-ef9f-456d-b4be-a294a7a0f01c	13
360507	fluvastatin (as fluvastatin sodium) 80 MG 24 HR Extended Release Oral Tablet	SY	3565bfd3-ef9f-456d-b4be-a294a7a0f01c	13
360507	fluvastatin 80 MG 24 HR Extended Release Oral Tablet	SY	3565bfd3-ef9f-456d-b4be-a294a7a0f01c	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0527-2580-32	00527258032	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0527-2580-32)	2021-05-07	0000-00-00	No	No	Current
0527-2580-37	00527258037	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0527-2580-37)	2022-03-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluvastatin Sodium	Lannett Company, Inc. \| Beijing Sciecure Pharmaceutical Co., Ltd.	2026-03-18	HUMAN PRESCRIPTION DRUG LABEL	13