Fingolimod
- Product NDC
- 70771-1603
- 11-digit product format
- 707711603
- Labeler code
- 70771
- Product ID
- 70771-1603_423dd0fd-c654-4de1-b535-947cd795758b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fingolimod
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA207994
- Marketing category
- ANDA
- Marketing start
- 2022-10-11
- 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 |
|---|
| 70771-1603 | FINGOLIMOD CAPSULE [ZYDUS LIFESCIENCES LIMITED] | 5 | Current NDC, Legacy NDC, 7 package rows | 20241201_5a0319b4-4bc6-4564-9687-9cfd5c1b23a8.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 |
|---|
| 70771-1603-1 | 70771160301 | 100 CAPSULE in 1 BOTTLE (70771-1603-1) | 100 capsule | 2022-10-11 | 0000-00-00 | No | No | Current |
| 70771-1603-3 | 70771160303 | 30 CAPSULE in 1 BOTTLE (70771-1603-3) | 30 capsule | 2022-10-11 | 0000-00-00 | No | No | Current |
| 70771-1603-7 | 70771160307 | 1 BLISTER PACK in 1 CARTON (70771-1603-7) / 7 CAPSULE in 1 BLISTER PACK | 1 blister pack | 2022-10-11 | 0000-00-00 | No | No | Current |
| 70771-1603-8 | 70771160308 | 4 BLISTER PACK in 1 CARTON (70771-1603-8) / 7 CAPSULE in 1 BLISTER PACK | 4 blister pack | 2022-10-11 | 0000-00-00 | No | No | Current |
| 70771-1603-9 | 70771160309 | 90 CAPSULE in 1 BOTTLE (70771-1603-9) | 90 capsule | 2022-10-11 | 0000-00-00 | No | No | Current |