Fingolimod
- Product NDC
- 62756-064
- 11-digit product format
- 627560064
- Labeler code
- 62756
- Product ID
- 62756-064_a0abec7c-e7a2-4bbf-936a-370e0eff4e9f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fingolimod
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA208014
- Marketing category
- ANDA
- Marketing start
- 2022-10-25
- 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#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62756-064 | FINGOLIMOD CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 7 | Current NDC, Legacy NDC, 6 package rows | 20241127_b228dac8-b07d-424d-b23b-a03573517c54.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 |
|---|
| 62756-064-57 | 62756006457 | 4 BLISTER PACK in 1 CARTON (62756-064-57) > 7 CAPSULE in 1 BLISTER PACK | 4 blister pack | 2022-10-25 | 0000-00-00 | No | No | Current |
| 62756-064-59 | 62756006459 | 1 BLISTER PACK in 1 CARTON (62756-064-59) / 7 CAPSULE in 1 BLISTER PACK | 1 blister pack | 2022-10-25 | 0000-00-00 | No | No | Current |
| 62756-064-81 | 62756006481 | 90 CAPSULE in 1 BOTTLE (62756-064-81) | 90 capsule | 2022-10-25 | 0000-00-00 | No | No | Current |
| 62756-064-83 | 62756006483 | 30 CAPSULE in 1 BOTTLE (62756-064-83) | 30 capsule | 2022-10-25 | 0000-00-00 | No | No | Current |
| 62756-064-96 | 62756006496 | 2 BLISTER PACK in 1 CARTON (62756-064-96) / 14 CAPSULE in 1 BLISTER PACK | 2 blister pack | 2022-10-25 | 0000-00-00 | No | No | Current |