Fluvastatin
- Product NDC
- 0093-7443
- 11-digit product format
- 000937443
- Labeler code
- 0093
- Product ID
- 0093-7443_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
- 40 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
Orange Book products#
| 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#
| 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.
| 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 | 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#
| 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 |
|---|---|
| FLUVASTATIN SODIUM | 40 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| PYF7O1FV7F | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| aad8b373-0aec-4efb-8e61-3d8114b31127 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 22ca7ed4-2e69-d74c-9eff-803d6d02a7be | Product name | 4 | 20211021 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0093-7443-01 | Fluvastatin | 100 in 1 BOTTLE | CAPSULE | 100 | 12 | |
| 0093-7443-56 | Fluvastatin | 30 in 1 BOTTLE | CAPSULE | 30 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0093-7443-01 | EA - Each | 0093-7443 | 7e929a90-a8c7-45ff-9b9d-e28f4f190e96 | 1 | 2013-02-13 |
| 0093-7443-56 | EA - Each | 0093-7443 | 124c9cc0-81a4-4adc-a6f5-a47aa127bc3b | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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.
| 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 | 078407 ANDA078407 |
| Fluvastatin | FLUVASTATIN | Bryant Ranch Prepack | 02db192f-0cdb-4aef-aa6e-cfb9b6cb0101 | 2025-10-21 | Warnings, Adverse reactions | 078407 ANDA078407 |
| Fluvastatin | FLUVASTATIN | Bryant Ranch Prepack | 48801d7c-99ac-4a78-b714-299e2a5562ea | 2025-06-26 | Warnings, Adverse reactions | 078407 ANDA078407 |
| Fluvastatin | FLUVASTATIN | Teva Pharmaceuticals USA, Inc. | aad8b373-0aec-4efb-8e61-3d8114b31127 | 2025-04-21 | Warnings, Adverse reactions | 078407 ANDA078407 0093-7443 |
| Fluvastatin | FLUVASTATIN | Bryant Ranch Prepack | e3c9f49c-051c-451a-8749-1a7bee820078 | 2024-07-25 | Warnings, Adverse reactions | 078407 ANDA078407 |
| Fluvastatin | FLUVASTATIN | Bryant Ranch Prepack | f5e8d1da-8911-42db-9f90-cba04b28d011 | 2024-01-11 | Warnings, Adverse reactions | 078407 ANDA078407 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310405 | fluvastatin sodium 40 MG Oral Capsule | PSN | e3c9f49c-051c-451a-8749-1a7bee820078 | 105 |
| 310405 | fluvastatin 40 MG Oral Capsule | SCD | e3c9f49c-051c-451a-8749-1a7bee820078 | 105 |
| 310405 | fluvastatin (as fluvastatin sodium) 40 MG Oral Capsule | SY | e3c9f49c-051c-451a-8749-1a7bee820078 | 105 |
| 310405 | fluvastatin sodium 40 MG Oral Capsule | PSN | ccd6bbe1-e293-4e1c-9ec4-e6c217612e77 | 101 |
| 310405 | fluvastatin 40 MG Oral Capsule | SCD | ccd6bbe1-e293-4e1c-9ec4-e6c217612e77 | 101 |
| 310405 | fluvastatin (as fluvastatin sodium) 40 MG Oral Capsule | SY | ccd6bbe1-e293-4e1c-9ec4-e6c217612e77 | 101 |
| 310405 | fluvastatin sodium 40 MG Oral Capsule | PSN | 02db192f-0cdb-4aef-aa6e-cfb9b6cb0101 | 100 |
| 310405 | fluvastatin sodium 40 MG Oral Capsule | PSN | 48801d7c-99ac-4a78-b714-299e2a5562ea | 100 |
| 310405 | fluvastatin 40 MG Oral Capsule | SCD | 48801d7c-99ac-4a78-b714-299e2a5562ea | 100 |
| 310405 | fluvastatin 40 MG Oral Capsule | SCD | 02db192f-0cdb-4aef-aa6e-cfb9b6cb0101 | 100 |
| 310405 | fluvastatin (as fluvastatin sodium) 40 MG Oral Capsule | SY | 48801d7c-99ac-4a78-b714-299e2a5562ea | 100 |
| 310405 | fluvastatin (as fluvastatin sodium) 40 MG Oral Capsule | SY | 02db192f-0cdb-4aef-aa6e-cfb9b6cb0101 | 100 |
| 310404 | fluvastatin sodium 20 MG Oral Capsule | PSN | aad8b373-0aec-4efb-8e61-3d8114b31127 | 12 |
| 310405 | fluvastatin sodium 40 MG Oral Capsule | PSN | aad8b373-0aec-4efb-8e61-3d8114b31127 | 12 |
| 310404 | fluvastatin 20 MG Oral Capsule | SCD | aad8b373-0aec-4efb-8e61-3d8114b31127 | 12 |
| 310405 | fluvastatin 40 MG Oral Capsule | SCD | aad8b373-0aec-4efb-8e61-3d8114b31127 | 12 |
| 310404 | fluvastatin (as fluvastatin sodium) 20 MG Oral Capsule | SY | aad8b373-0aec-4efb-8e61-3d8114b31127 | 12 |
| 310405 | fluvastatin (as fluvastatin sodium) 40 MG Oral Capsule | SY | aad8b373-0aec-4efb-8e61-3d8114b31127 | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0093-7443-01 | 00093744301 | 100 CAPSULE in 1 BOTTLE (0093-7443-01) | 100 capsule | 2012-07-10 | 0000-00-00 | No | No | Current |
| 0093-7443-56 | 00093744356 | 30 CAPSULE in 1 BOTTLE (0093-7443-56) | 30 capsule | 2012-07-05 | 0000-00-00 | No | No | Current |