Fingolimod
- Product NDC
- 46708-228
- 11-digit product format
- 467080228
- Labeler code
- 46708
- Product ID
- 46708-228_d0538769-3cec-4cf2-97e5-41e79599c181
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fingolimod
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA207974
- Marketing category
- ANDA
- Marketing start
- 2026-04-28
- 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
- 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 |
|---|
| 46708-228-10 | Fingolimod | 10 in 1 BLISTER PACK | CAPSULE | 10 | | 1 |
| 46708-228-10 | Fingolimod | 100 in 1 CARTON | CAPSULE | 100 | | 1 |
| 46708-228-30 | Fingolimod | 30 in 1 BOTTLE | CAPSULE | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-228-10 | 46708022810 | 100 BLISTER PACK in 1 CARTON (46708-228-10) / 10 CAPSULE in 1 BLISTER PACK | 100 blister pack | 2026-04-28 | No | No | Current |
| 46708-228-30 | 46708022830 | 30 CAPSULE in 1 BOTTLE (46708-228-30) | 30 capsule | 2026-04-28 | No | No | Current |