FINGOLIMOD HYDROCHLORIDE
- Product NDC
- 16729-342
- 11-digit product format
- 167290342
- Labeler code
- 16729
- Product ID
- 16729-342_4148bb57-7d2c-1724-e063-6294a90a34fd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FINGOLIMOD HYDROCHLORIDE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA207991
- Marketing category
- ANDA
- Marketing start
- 2022-10-18
- 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 HYDROCHLORIDE
- 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 |
|---|
| 16729-342-10 | FINGOLIMOD HYDROCHLORIDE | 30 in 1 BOTTLE | CAPSULE | 30 | | 5 |
| 16729-342-15 | FINGOLIMOD HYDROCHLORIDE | 90 in 1 BOTTLE | CAPSULE | 90 | | 5 |
| 16729-342-17 | FINGOLIMOD HYDROCHLORIDE | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 5 |
| 16729-342-87 | FINGOLIMOD HYDROCHLORIDE | 7 in 1 CARTON | CAPSULE | 7 | | 5 |
| 16729-342-88 | FINGOLIMOD HYDROCHLORIDE | 28 in 1 CARTON | CAPSULE | 28 | | 5 |
| 16729-342-89 | FINGOLIMOD HYDROCHLORIDE | 7 in 1 BOTTLE | CAPSULE | 7 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-342 | FINGOLIMOD HYDROCHLORIDE CAPSULE [ACCORD HEALTHCARE INC.] | 4 | Current NDC, Legacy NDC, 6 package rows | 20240221_65e59a51-c9c2-47b4-84fc-e0f8879eb26c.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 |
|---|
| 16729-342-10 | 16729034210 | 30 CAPSULE in 1 BOTTLE (16729-342-10) | 30 capsule | 2022-10-18 | 0000-00-00 | No | No | Current |
| 16729-342-15 | 16729034215 | 90 in 1 BOTTLE | | | | | | Historical |
| 16729-342-17 | 16729034217 | 1000 in 1 BOTTLE | | | | | | Historical |
| 16729-342-87 | 16729034287 | 7 in 1 CARTON | | | | | | Historical |
| 16729-342-88 | 16729034288 | 28 in 1 CARTON | | | | | | Historical |
| 16729-342-89 | 16729034289 | 7 in 1 BOTTLE | | | | | | Historical |