eribulin mesylate
- Product NDC
- 68083-592
- 11-digit product format
- 680830592
- Labeler code
- 68083
- Product ID
- 68083-592_5db5b24e-3893-4985-a658-731cb840eb76
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- eribulin mesylate
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA218047
- Marketing category
- ANDA
- Marketing start
- 2024-04-05
- Substance
- ERIBULIN MESYLATE
- Active strength
- .5 mg/mL
- Pharmacologic classes
- Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- eribulin mesylate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ERIBULIN MESYLATE | .5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | AV9U0660CW |
| Rxcui | 1045456 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-592-01 | eribulin mesylate | 1 in 1 CARTON | INJECTION | 1 | | 3 |
| 68083-592-01 | eribulin mesylate | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 2 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-592 | ERIBULIN MESYLATE INJECTION [GLAND PHARMA LIMITED] | 3 | Current NDC, 2 package rows | 20240413_f57835e2-4c53-4e93-b54b-7d7a5000ae3d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68083-592-01 | 68083059201 | 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-592-01) / 2 mL in 1 VIAL, SINGLE-DOSE | 2024-04-05 | No | No | Current |