Fluvastatin

Product NDC: 63629-8812
11-digit product format: 636298812
Labeler code: 63629
Product ID: 63629-8812_a94b896f-6170-4ada-970d-9e1e130c7eab
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluvastatin
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA078407
Marketing category: ANDA
Marketing start: 2012-07-05
Substance: FLUVASTATIN SODIUM
Active strength: 20 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078407-001	FLUVASTATIN SODIUM	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB		2012-06-12
A078407-002	FLUVASTATIN SODIUM	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB		2012-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078407-001	AB
A078407-002	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 · 82 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	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078407-001	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078407-002	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-12	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A078407-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078407-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078407-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078407-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078407-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078407-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078407-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078407-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078407-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078407-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078407-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078407-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078407-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078407-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078407-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078407-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078407-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078407-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078407-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078407-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078407-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078407-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078407-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078407-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078407-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078407-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078407-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078407-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078407-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078407-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078407-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078407-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078407-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078407-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078407-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078407-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078407-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078407-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078407-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078407-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUVASTATIN SODIUM	20 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
310404	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
f5e8d1da-8911-42db-9f90-cba04b28d011	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
63629-8812-1	Fluvastatin	100 in 1 BOTTLE	CAPSULE	100		102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-8812-1	EA - Each	63629-8812	9e0901b8-9286-40b6-903f-5996c0488fce	1	2021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8812	FLUVASTATIN CAPSULE [BRYANT RANCH PREPACK]	102	Current NDC, Legacy NDC, 1 package rows	20240113_f5e8d1da-8911-42db-9f90-cba04b28d011.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluvastatin	FLUVASTATIN	Bryant Ranch Prepack	ccd6bbe1-e293-4e1c-9ec4-e6c217612e77	2026-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078407 application number: ANDA078407
Fluvastatin	FLUVASTATIN	Bryant Ranch Prepack	02db192f-0cdb-4aef-aa6e-cfb9b6cb0101	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078407 application number: ANDA078407
Fluvastatin	FLUVASTATIN	Bryant Ranch Prepack	48801d7c-99ac-4a78-b714-299e2a5562ea	2025-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078407 application number: ANDA078407
Fluvastatin	FLUVASTATIN	Teva Pharmaceuticals USA, Inc.	aad8b373-0aec-4efb-8e61-3d8114b31127	2025-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078407 application number: ANDA078407
Fluvastatin	FLUVASTATIN	Bryant Ranch Prepack	e3c9f49c-051c-451a-8749-1a7bee820078	2024-07-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078407 application number: ANDA078407
Fluvastatin	FLUVASTATIN	Bryant Ranch Prepack	f5e8d1da-8911-42db-9f90-cba04b28d011	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078407 application number: ANDA078407 ndc (product): 63629-8812

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
PYF7O1FV7F	FLUVASTATIN SODIUM	93957-55-2	FLUVASTATIN SODIUM
4L066368AS	FLUVASTATIN	93957-54-1	Fluvastatin

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310404	fluvastatin sodium 20 MG Oral Capsule	PSN	f5e8d1da-8911-42db-9f90-cba04b28d011	102
310404	fluvastatin 20 MG Oral Capsule	SCD	f5e8d1da-8911-42db-9f90-cba04b28d011	102
310404	fluvastatin (as fluvastatin sodium) 20 MG Oral Capsule	SY	f5e8d1da-8911-42db-9f90-cba04b28d011	102

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8812-1	63629881201	100 CAPSULE in 1 BOTTLE (63629-8812-1)	100 capsule	2021-09-10	0000-00-00	No	No	Current