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
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 Identifiers#
| Field | Values |
|---|---|
| Unii | PYF7O1FV7F |
| Rxcui | 310404, 310405 |
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#
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 |