fingolimod
- Product NDC
- 64980-449
- 11-digit product format
- 649800449
- Labeler code
- 64980
- Product ID
- 64980-449_2622c15a-3781-3016-e063-6294a90a84d5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fingolimod hcl
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA207939
- Marketing category
- ANDA
- Marketing start
- 2021-11-10
- 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 |
|---|
| 64980-449-03 | fingolimod | 30 in 1 BOTTLE | CAPSULE | 30 | | 17 |
| 64980-449-07 | fingolimod | 7 in 1 CARTON | CAPSULE | 7 | | 17 |
| 64980-449-28 | fingolimod | 28 in 1 CARTON | CAPSULE | 28 | | 17 |
| 64980-449-97 | fingolimod | 7 in 1 BLISTER PACK | CAPSULE | 7 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64980-449 | FINGOLIMOD (FINGOLIMOD HCL) CAPSULE [RISING PHARMA HOLDINGS, INC.] | 17 | Current NDC, Legacy NDC, 4 package rows | 20241106_99e7daf4-ea90-5e47-e053-2a95a90ac1b7.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 |
|---|
| 64980-449-03 | 64980044903 | 30 CAPSULE in 1 BOTTLE (64980-449-03) | 30 capsule | 2023-09-04 | 0000-00-00 | No | No | Current |
| 64980-449-07 | 64980044907 | 7 CAPSULE in 1 CARTON (64980-449-07) | 7 capsule | 2021-01-01 | 0000-00-00 | No | No | Current |
| 64980-449-28 | 64980044928 | 28 CAPSULE in 1 CARTON (64980-449-28) | 28 capsule | 2021-01-01 | 0000-00-00 | No | No | Current |
| 64980-449-97 | 64980044997 | 7 CAPSULE in 1 BLISTER PACK (64980-449-97) | 7 capsule | 2021-01-01 | 0000-00-00 | No | No | Current |