FINGOLIMOD
- Product NDC
- 82009-143
- 11-digit product format
- 820090143
- Labeler code
- 82009
- Product ID
- 82009-143_c10504a7-d1e3-b3d2-2b35-43f1e602d8c9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FINGOLIMOD
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Quallent Pharmaceuticals Health LLC
- Application
- ANDA207979
- Marketing category
- ANDA
- Marketing start
- 2024-03-28
- Substance
- FINGOLIMOD HYDROCHLORIDE
- 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 HYDROCHLORIDE | .5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G926EC510T |
| Rxcui | 1012895 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82009-143-30 | FINGOLIMOD | 30 in 1 BOTTLE | CAPSULE | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82009-143 | FINGOLIMOD CAPSULE [QUALLENT PHARMACEUTICALS HEALTH LLC] | 2 | Current NDC, 1 package rows | 20250302_5434bd4a-2610-0e17-4f14-513ff1cbb822.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82009-143-30 | 82009014330 | 30 CAPSULE in 1 BOTTLE (82009-143-30) | 30 capsule | 2024-03-28 | No | No | Historical |