Home NDC 0378-8021 Fluvastatin Sodium
Product NDC 0378-8021
11-digit product format 003788021
Labeler code 0378
Product ID 0378-8021_f31c30b0-95b9-47d4-8ef8-f6fa51a2e5b9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluvastatin
Dosage form CAPSULE
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA090595
Marketing category ANDA
Marketing start 2012-04-11
Substance FLUVASTATIN SODIUM
Active strength 40 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090595-001 FLUVASTATIN SODIUM FLUVASTATIN SODIUM EQ 20MG BASE CAPSULE / ORAL AB 2012-04-11 A090595-002 FLUVASTATIN SODIUM FLUVASTATIN SODIUM EQ 40MG BASE CAPSULE / ORAL AB RS 2012-04-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A090595-001 FLUVASTATIN SODIUM EQ 20MG BASE CAPSULE / ORAL AB 2012-04-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090595-002 FLUVASTATIN SODIUM EQ 40MG BASE CAPSULE / ORAL AB RS 2012-04-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090595-001 FLUVASTATIN SODIUM EQ 20MG BASE CAPSULE / ORAL AB 2012-04-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090595-002 FLUVASTATIN SODIUM EQ 40MG BASE CAPSULE / ORAL AB RS 2012-04-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090595-001 FLUVASTATIN SODIUM EQ 20MG BASE CAPSULE / ORAL AB 2012-04-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090595-002 FLUVASTATIN SODIUM EQ 40MG BASE CAPSULE / ORAL AB RS 2012-04-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090595-001 FLUVASTATIN SODIUM EQ 20MG BASE CAPSULE / ORAL AB 2012-04-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090595-002 FLUVASTATIN SODIUM EQ 40MG BASE CAPSULE / ORAL AB RS 2012-04-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090595-001 FLUVASTATIN SODIUM EQ 20MG BASE CAPSULE / ORAL AB 2012-04-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090595-002 FLUVASTATIN SODIUM EQ 40MG BASE CAPSULE / ORAL AB RS 2012-04-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090595-001 FLUVASTATIN SODIUM EQ 20MG BASE CAPSULE / ORAL AB 2012-04-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090595-002 FLUVASTATIN SODIUM EQ 40MG BASE CAPSULE / ORAL AB RS 2012-04-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090595-001 FLUVASTATIN SODIUM EQ 20MG BASE CAPSULE / ORAL AB 2012-04-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090595-002 FLUVASTATIN SODIUM EQ 40MG BASE CAPSULE / ORAL AB RS 2012-04-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090595-001 FLUVASTATIN SODIUM EQ 20MG BASE CAPSULE / ORAL AB 2012-04-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090595-002 FLUVASTATIN SODIUM EQ 40MG BASE CAPSULE / ORAL AB RS 2012-04-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090595-001 FLUVASTATIN SODIUM EQ 20MG BASE CAPSULE / ORAL AB 2012-04-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090595-002 FLUVASTATIN SODIUM EQ 40MG BASE CAPSULE / ORAL AB RS 2012-04-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090595-001 FLUVASTATIN SODIUM EQ 20MG BASE CAPSULE / ORAL AB 2012-04-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090595-002 FLUVASTATIN SODIUM EQ 40MG BASE CAPSULE / ORAL AB RS 2012-04-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090595-001 FLUVASTATIN SODIUM EQ 20MG BASE CAPSULE / ORAL AB 2012-04-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090595-002 FLUVASTATIN SODIUM EQ 40MG BASE CAPSULE / ORAL AB RS 2012-04-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090595-001 FLUVASTATIN SODIUM EQ 20MG BASE CAPSULE / ORAL AB 2012-04-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090595-002 FLUVASTATIN SODIUM EQ 40MG BASE CAPSULE / ORAL AB RS 2012-04-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090595-001 FLUVASTATIN SODIUM EQ 20MG BASE CAPSULE / ORAL AB 2012-04-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090595-002 FLUVASTATIN SODIUM EQ 40MG BASE CAPSULE / ORAL AB RS 2012-04-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090595-001 FLUVASTATIN SODIUM EQ 20MG BASE CAPSULE / ORAL AB 2012-04-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090595-002 FLUVASTATIN SODIUM EQ 40MG BASE CAPSULE / ORAL AB RS 2012-04-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090595-001 FLUVASTATIN SODIUM EQ 20MG BASE CAPSULE / ORAL AB 2012-04-11 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090595-002 FLUVASTATIN SODIUM EQ 40MG BASE CAPSULE / ORAL AB RS 2012-04-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090595-001 FLUVASTATIN SODIUM EQ 20MG BASE CAPSULE / ORAL AB 2012-04-11 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090595-002 FLUVASTATIN SODIUM EQ 40MG BASE CAPSULE / ORAL AB RS 2012-04-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090595-001 FLUVASTATIN SODIUM EQ 20MG BASE CAPSULE / ORAL AB 2012-04-11 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090595-002 FLUVASTATIN SODIUM EQ 40MG BASE CAPSULE / ORAL AB RS 2012-04-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090595-001 FLUVASTATIN SODIUM EQ 20MG BASE CAPSULE / ORAL AB 2012-04-11 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090595-002 FLUVASTATIN SODIUM EQ 40MG BASE CAPSULE / ORAL AB RS 2012-04-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090595-001 FLUVASTATIN SODIUM EQ 20MG BASE CAPSULE / ORAL AB 2012-04-11 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090595-002 FLUVASTATIN SODIUM EQ 40MG BASE CAPSULE / ORAL AB RS 2012-04-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090595-001 FLUVASTATIN SODIUM EQ 20MG BASE CAPSULE / ORAL AB 2012-04-11 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A090595-002 FLUVASTATIN SODIUM EQ 40MG BASE CAPSULE / ORAL AB RS 2012-04-11 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
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 40 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310404 Internal RxNorm lookup 310405 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0378-8021-77 Fluvastatin Sodium 90 in 1 BOTTLE, PLASTIC CAPSULE 90 13 0378-8021-93 Fluvastatin Sodium 30 in 1 BOTTLE, PLASTIC CAPSULE 30 13
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-8021 FLUVASTATIN SODIUM (FLUVASTATIN) CAPSULE [MYLAN PHARMACEUTICALS INC.] 12 Current NDC, Legacy NDC, 2 package rows 20241204_d0a7247c-5d83-4bc1-840f-c58314d14195.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0378-8021-77 00378802177 90 CAPSULE in 1 BOTTLE, PLASTIC (0378-8021-77) 90 capsule 2012-04-11 0000-00-00 No No Current 0378-8021-93 00378802193 30 CAPSULE in 1 BOTTLE, PLASTIC (0378-8021-93) 30 capsule 2012-04-11 0000-00-00 No No Current