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