Fluvastatin Sodium

Product NDC: 0093-7446
11-digit product format: 000937446
Labeler code: 0093
Product ID: 0093-7446_82469f87-7755-4dda-a92d-a27856d0fe0e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluvastatin Sodium
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA079011
Marketing category: ANDA
Marketing start: 2016-06-02
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: 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A079011-001	FLUVASTATIN SODIUM	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-01-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079011-001	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.

Product history page 1 of 2 · 41 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	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079011-001	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-01-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A079011-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079011-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079011-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079011-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079011-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079011-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079011-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079011-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079011-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079011-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079011-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079011-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079011-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079011-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079011-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079011-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079011-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079011-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079011-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079011-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079011-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079011-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079011-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079011-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079011-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079011-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079011-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079011-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079011-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079011-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079011-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079011-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079011-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079011-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079011-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079011-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079011-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079011-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079011-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079011-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

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
cc55110f-1ad6-4f97-840d-62b3a5ac415a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
22ca7ed4-2e69-d74c-9eff-803d6d02a7be	Product name	4	20211021
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
0093-7446-01	Fluvastatin Sodium	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100		10
0093-7446-56	Fluvastatin Sodium	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-7446-01	EA - Each	0093-7446	940ff00b-ba2b-4666-ae06-11f6ce1fc3e9	1	2016-07-19
0093-7446-56	EA - Each	0093-7446	6aec1f9a-e839-4a3d-9bd8-d28146ad6d2d	1	2016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-7446	FLUVASTATIN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA, INC.]	10	Current NDC, Legacy NDC, 2 package rows	20240921_cc55110f-1ad6-4f97-840d-62b3a5ac415a.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	Teva Pharmaceuticals USA, Inc.	cc55110f-1ad6-4f97-840d-62b3a5ac415a	2024-09-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079011 application number: ANDA079011 ndc (product): 0093-7446

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	cc55110f-1ad6-4f97-840d-62b3a5ac415a	10
360507	24 HR fluvastatin 80 MG Extended Release Oral Tablet	SCD	cc55110f-1ad6-4f97-840d-62b3a5ac415a	10
360507	fluvastatin (as fluvastatin sodium) 80 MG 24 HR Extended Release Oral Tablet	SY	cc55110f-1ad6-4f97-840d-62b3a5ac415a	10
360507	fluvastatin 80 MG 24 HR Extended Release Oral Tablet	SY	cc55110f-1ad6-4f97-840d-62b3a5ac415a	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-7446-01	00093744601	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-7446-01)	2016-06-02	0000-00-00	No	No	Current
0093-7446-56	00093744656	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-7446-56)	2016-06-02	0000-00-00	No	No	Current