Fosaprepitant
- Product NDC
- 83634-776
- 11-digit product format
- 836340776
- Labeler code
- 83634
- Product ID
- 83634-776_243b704e-ea10-4e4e-97dc-56b532be7f7b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fosaprepitant dimeglumine
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Avenacy, LLC
- Application
- ANDA212143
- Marketing category
- ANDA
- Marketing start
- 2024-02-28
- Substance
- FOSAPREPITANT DIMEGLUMINE
- Active strength
- 150 mg/5mL
- Pharmacologic classes
- Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fosaprepitant
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FOSAPREPITANT DIMEGLUMINE | 150 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | D35FM8T64X |
| Rxcui | 1731077 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83634-776-10 | Fosaprepitant | 5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 | | 2 |
| 83634-776-10 | Fosaprepitant | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83634-776 | FOSAPREPITANT (FOSAPREPITANT DIMEGLUMINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AVENACY, INC.] | 1 | Current NDC, 2 package rows | 20240229_3f942e4c-e26a-4155-9e14-344b2970b189.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83634-776-10 | 83634077610 | 1 VIAL in 1 CARTON (83634-776-10) / 5 mL in 1 VIAL | 1 vial | 2024-02-28 | No | No | Current |