Fingolimod
- Product NDC
- 31722-889
- 11-digit product format
- 317220889
- Labeler code
- 31722
- Product ID
- 31722-889_46342e58-9ad6-7e95-e063-6294a90aa7b4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fingolimod
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA207933
- Marketing category
- ANDA
- Marketing start
- 2019-09-27
- 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 |
|---|
| 31722-889-30 | Fingolimod | 30 in 1 BOTTLE | CAPSULE | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-889 | FINGOLIMOD (FINGOLIMOD) CAPSULE [CAMBER PHARMACEUTICALS, INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240929_c3199508-3d6a-4e44-96f0-bbde9969edcb.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 |
|---|
| 31722-889-30 | 31722088930 | 30 CAPSULE in 1 BOTTLE (31722-889-30) | 30 capsule | 2019-09-27 | 0000-00-00 | No | No | Current |