FINGOLIMOD
- Product NDC
- 43547-003
- 11-digit product format
- 435470003
- Labeler code
- 43547
- Product ID
- 43547-003_8a52d7dc-58d1-4dec-bfbd-5424ec30b984
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fingolimod
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Solco Healthcare US, LLC
- Application
- ANDA208003
- Marketing category
- ANDA
- Marketing start
- 2020-02-17
- Substance
- FINGOLIMOD
- Active strength
- .5 mg/1
- Pharmacologic classes
- Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FINGOLIMOD
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FINGOLIMOD | .5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3QN8BYN5QF |
| Rxcui | 1012895 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43547-003-03 | FINGOLIMOD | 30 in 1 BOTTLE | CAPSULE | 30 | | 2 |
| 43547-003-09 | FINGOLIMOD | 90 in 1 BOTTLE | CAPSULE | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43547-003 | FINGOLIMOD CAPSULE [SOLCO HEALTHCARE US, LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20240927_6c0faf2b-21fb-4830-bb78-5f2dbceb2c82.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 |
|---|
| 43547-003-03 | 43547000303 | 30 CAPSULE in 1 BOTTLE (43547-003-03) | 30 capsule | 2021-10-26 | 0000-00-00 | No | No | Current |
| 43547-003-09 | 43547000309 | 90 CAPSULE in 1 BOTTLE (43547-003-09) | 90 capsule | 2021-10-26 | 0000-00-00 | No | No | Current |