Fluvastatin

Product NDC
0093-7442
11-digit product format
000937442
Labeler code
0093
Product ID
0093-7442_1fb50b66-e9d0-4fd1-928e-b37c4fff4ccc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluvastatin
Dosage form
CAPSULE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078407-001FLUVASTATIN SODIUMFLUVASTATIN SODIUMEQ 20MG BASECAPSULE / ORALAB2012-06-12
A078407-002FLUVASTATIN SODIUMFLUVASTATIN SODIUMEQ 40MG BASECAPSULE / ORALAB2012-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078407-001AB
A078407-002AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078407-001FLUVASTATIN SODIUMEQ 20MG BASECAPSULE / ORALAB2012-06-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078407-002FLUVASTATIN SODIUMEQ 40MG BASECAPSULE / ORALAB2012-06-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078407-001FLUVASTATIN SODIUMEQ 20MG BASECAPSULE / ORALAB2012-06-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078407-002FLUVASTATIN SODIUMEQ 40MG BASECAPSULE / ORALAB2012-06-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A078407-001FLUVASTATIN SODIUMEQ 20MG BASECAPSULE / ORALAB2012-06-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078407-002FLUVASTATIN SODIUMEQ 40MG BASECAPSULE / ORALAB2012-06-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078407-001FLUVASTATIN SODIUMEQ 20MG BASECAPSULE / ORALAB2012-06-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078407-002FLUVASTATIN SODIUMEQ 40MG BASECAPSULE / ORALAB2012-06-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078407-001FLUVASTATIN SODIUMEQ 20MG BASECAPSULE / ORALAB2012-06-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078407-002FLUVASTATIN SODIUMEQ 40MG BASECAPSULE / ORALAB2012-06-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078407-001FLUVASTATIN SODIUMEQ 20MG BASECAPSULE / ORALAB2012-06-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078407-002FLUVASTATIN SODIUMEQ 40MG BASECAPSULE / ORALAB2012-06-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078407-001FLUVASTATIN SODIUMEQ 20MG BASECAPSULE / ORALAB2012-06-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078407-002FLUVASTATIN SODIUMEQ 40MG BASECAPSULE / ORALAB2012-06-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078407-001FLUVASTATIN SODIUMEQ 20MG BASECAPSULE / ORALAB2012-06-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078407-002FLUVASTATIN SODIUMEQ 40MG BASECAPSULE / ORALAB2012-06-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078407-001FLUVASTATIN SODIUMEQ 20MG BASECAPSULE / ORALAB2012-06-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078407-002FLUVASTATIN SODIUMEQ 40MG BASECAPSULE / ORALAB2012-06-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078407-001FLUVASTATIN SODIUMEQ 20MG BASECAPSULE / ORALAB2012-06-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A078407-002FLUVASTATIN SODIUMEQ 40MG BASECAPSULE / ORALAB2012-06-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078407-001FLUVASTATIN SODIUMEQ 20MG BASECAPSULE / ORALAB2012-06-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078407-002FLUVASTATIN SODIUMEQ 40MG BASECAPSULE / ORALAB2012-06-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078407-001FLUVASTATIN SODIUMEQ 20MG BASECAPSULE / ORALAB2012-06-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078407-002FLUVASTATIN SODIUMEQ 40MG BASECAPSULE / ORALAB2012-06-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078407-001FLUVASTATIN SODIUMEQ 20MG BASECAPSULE / ORALAB2012-06-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078407-002FLUVASTATIN SODIUMEQ 40MG BASECAPSULE / ORALAB2012-06-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078407-001FLUVASTATIN SODIUMEQ 20MG BASECAPSULE / ORALAB2012-06-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078407-002FLUVASTATIN SODIUMEQ 40MG BASECAPSULE / ORALAB2012-06-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078407-001FLUVASTATIN SODIUMEQ 20MG BASECAPSULE / ORALAB2012-06-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078407-002FLUVASTATIN SODIUMEQ 40MG BASECAPSULE / ORALAB2012-06-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078407-001FLUVASTATIN SODIUMEQ 20MG BASECAPSULE / ORALAB2012-06-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078407-002FLUVASTATIN SODIUMEQ 40MG BASECAPSULE / ORALAB2012-06-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078407-001FLUVASTATIN SODIUMEQ 20MG BASECAPSULE / ORALAB2012-06-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078407-002FLUVASTATIN SODIUMEQ 40MG BASECAPSULE / ORALAB2012-06-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078407-001FLUVASTATIN SODIUMEQ 20MG BASECAPSULE / ORALAB2012-06-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078407-002FLUVASTATIN SODIUMEQ 40MG BASECAPSULE / ORALAB2012-06-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078407-001FLUVASTATIN SODIUMEQ 20MG BASECAPSULE / ORALAB2012-06-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078407-002FLUVASTATIN SODIUMEQ 40MG BASECAPSULE / ORALAB2012-06-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078407-001FLUVASTATIN SODIUMEQ 20MG BASECAPSULE / ORALAB2012-06-12782e0a99824c…
2021-12-28 21:50 UTC2021-12A078407-002FLUVASTATIN SODIUMEQ 40MG BASECAPSULE / ORALAB2012-06-12782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078407-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078407-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078407-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078407-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078407-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078407-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078407-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078407-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078407-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078407-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078407-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078407-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078407-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078407-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078407-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078407-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078407-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078407-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078407-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078407-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078407-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078407-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078407-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078407-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078407-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078407-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078407-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078407-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078407-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078407-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078407-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078407-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078407-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078407-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078407-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078407-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078407-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078407-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078407-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A078407-002AB1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUVASTATIN SODIUM20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PYF7O1FV7FInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310404Internal RxNorm lookup
310405Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
aad8b373-0aec-4efb-8e61-3d8114b31127Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
22ca7ed4-2e69-d74c-9eff-803d6d02a7beProduct name420211021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-7442-01Fluvastatin100 in 1 BOTTLECAPSULE10012
0093-7442-56Fluvastatin30 in 1 BOTTLECAPSULE3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7442-01EA - Each0093-74421a85b40d-4a2d-4cae-92a8-bb359491480e12013-02-13
0093-7442-56EA - Each0093-7442cca6cd74-ed04-44db-a2b7-04fb41f430b812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUVASTATIN SODIUMACTIVE INGREDIENTPYF7O1FV7FFLUVASTATIN CAPSULE [TEVA PHARMACEUTICALS USA INC]4
FLUVASTATINACTIVE MOIETY4L066368ASFLUVASTATIN CAPSULE [TEVA PHARMACEUTICALS USA INC]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKFLUVASTATIN CAPSULE [TEVA PHARMACEUTICALS USA INC]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FLUVASTATIN CAPSULE [TEVA PHARMACEUTICALS USA INC]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFLUVASTATIN CAPSULE [TEVA PHARMACEUTICALS USA INC]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FLUVASTATIN CAPSULE [TEVA PHARMACEUTICALS USA INC]4
GELATININACTIVE INGREDIENT2G86QN327LFLUVASTATIN CAPSULE [TEVA PHARMACEUTICALS USA INC]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFLUVASTATIN CAPSULE [TEVA PHARMACEUTICALS USA INC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUVASTATIN CAPSULE [TEVA PHARMACEUTICALS USA INC]4
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TFLUVASTATIN CAPSULE [TEVA PHARMACEUTICALS USA INC]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLUVASTATIN CAPSULE [TEVA PHARMACEUTICALS USA INC]4
SHELLACINACTIVE INGREDIENT46N107B71OFLUVASTATIN CAPSULE [TEVA PHARMACEUTICALS USA INC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLUVASTATIN CAPSULE [TEVA PHARMACEUTICALS USA INC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUVASTATIN CAPSULE [TEVA PHARMACEUTICALS USA INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-7442FLUVASTATIN CAPSULE [TEVA PHARMACEUTICALS USA, INC.]11Current NDC, Legacy NDC, 2 package rows20220721_aad8b373-0aec-4efb-8e61-3d8114b31127.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluvastatinFLUVASTATINBryant Ranch Prepackccd6bbe1-e293-4e1c-9ec4-e6c217612e772026-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078407
application number: ANDA078407
FluvastatinFLUVASTATINBryant Ranch Prepack02db192f-0cdb-4aef-aa6e-cfb9b6cb01012025-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078407
application number: ANDA078407
FluvastatinFLUVASTATINBryant Ranch Prepack48801d7c-99ac-4a78-b714-299e2a5562ea2025-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078407
application number: ANDA078407
FluvastatinFLUVASTATINTeva Pharmaceuticals USA, Inc.aad8b373-0aec-4efb-8e61-3d8114b311272025-04-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078407
application number: ANDA078407
ndc (product): 0093-7442
FluvastatinFLUVASTATINBryant Ranch Prepacke3c9f49c-051c-451a-8749-1a7bee8200782024-07-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078407
application number: ANDA078407
FluvastatinFLUVASTATINBryant Ranch Prepackf5e8d1da-8911-42db-9f90-cba04b28d0112024-01-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078407
application number: ANDA078407

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310404fluvastatin sodium 20 MG Oral CapsulePSNf5e8d1da-8911-42db-9f90-cba04b28d011102
310404fluvastatin 20 MG Oral CapsuleSCDf5e8d1da-8911-42db-9f90-cba04b28d011102
310404fluvastatin (as fluvastatin sodium) 20 MG Oral CapsuleSYf5e8d1da-8911-42db-9f90-cba04b28d011102
310404fluvastatin sodium 20 MG Oral CapsulePSNaad8b373-0aec-4efb-8e61-3d8114b3112712
310405fluvastatin sodium 40 MG Oral CapsulePSNaad8b373-0aec-4efb-8e61-3d8114b3112712
310404fluvastatin 20 MG Oral CapsuleSCDaad8b373-0aec-4efb-8e61-3d8114b3112712
310405fluvastatin 40 MG Oral CapsuleSCDaad8b373-0aec-4efb-8e61-3d8114b3112712
310404fluvastatin (as fluvastatin sodium) 20 MG Oral CapsuleSYaad8b373-0aec-4efb-8e61-3d8114b3112712
310405fluvastatin (as fluvastatin sodium) 40 MG Oral CapsuleSYaad8b373-0aec-4efb-8e61-3d8114b3112712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-7442-0100093744201100 CAPSULE in 1 BOTTLE (0093-7442-01) 100 capsule2012-07-120000-00-00NoNoCurrent
0093-7442-560009374425630 CAPSULE in 1 BOTTLE (0093-7442-56) 30 capsule2012-07-050000-00-00NoNoCurrent