Fingolimod
- Product NDC
- 0378-4525
- 11-digit product format
- 003784525
- Labeler code
- 0378
- Product ID
- 0378-4525_3f9827b7-f7b0-4c5a-a53d-b08641d45beb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fingolimod
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA208005
- Marketing category
- ANDA
- Marketing start
- 2022-09-22
- Marketing end
- 0000-00-00
- Substance
- FINGOLIMOD HYDROCHLORIDE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-4525 | FINGOLIMOD CAPSULE [MYLAN PHARMACEUTICALS INC.] | 6 | Legacy NDC | 20250316_3f9827b7-f7b0-4c5a-a53d-b08641d45beb.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-4525-93 | 00378452593 | 30 CAPSULE in 1 BOTTLE, PLASTIC (0378-4525-93) | 30 capsule | 2022-09-22 | 0000-00-00 | No | No | Current |