Fingolimod
- Product NDC
- 0480-7820
- 11-digit product format
- 004807820
- Labeler code
- 0480
- Product ID
- 0480-7820_26a5f3bb-96f1-4148-a6b2-a8f5ce83c0d1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fingolimod
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals, Inc.
- Application
- ANDA208008
- Marketing category
- ANDA
- Marketing start
- 2024-02-14
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fingolimod
- Listing expiration
- 2027-12-31
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 |
|---|
| 0480-7820-56 | Fingolimod | 30 in 1 BOTTLE | CAPSULE | 30 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0480-7820 | FINGOLIMOD CAPSULE [TEVA PHARMACEUTICALS, INC.] | 6 | Current NDC, 1 package rows | 20250412_d9aa1078-fd72-47ef-84b2-2e1ad17b12a2.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 |
|---|
| 0480-7820-56 | 00480782056 | 30 CAPSULE in 1 BOTTLE (0480-7820-56) | 30 capsule | 2024-02-14 | No | No | Historical |