FAVLYXA
- Product NDC
- 83831-143
- 11-digit product format
- 838310143
- Labeler code
- 83831
- Product ID
- 83831-143_c8c3a5e0-277e-4d3e-910c-62cbc241cc3a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluorouracil
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Avyxa Pharma, LLC
- Application
- NDA220201
- Marketing category
- NDA
- Marketing start
- 2026-04-01
- Substance
- FLUOROURACIL
- Active strength
- 25 mg/mL
- Pharmacologic classes
- Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FAVLYXA
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FLUOROURACIL | 25 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | U3P01618RT |
| Rxcui | 2738666, 2738672 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7dc9482d-9b87-4471-9708-4f1b4585846b | Product name | 2 | 20250723 |
| a2ca0bf8-8306-49cc-93a3-3e6e4137c7cb | Product name | 5 | 20250630 |
| dc0d2364-4811-4665-a3ee-7ed8c7301465 | Product name | 2 | 20171219 |
| 62fb8671-1693-49d8-8aab-0c1bfdd6794e | Product name | 1 | 20151005 |
| 878ca466-81fd-9d24-1349-31baf36065c6 | Product name | 2 | 20150506 |
| 630d1bc2-ae6b-fd31-1264-c4733e788193 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83831-143-01 | FAVLYXA | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | 2 | |
| 83831-143-01 | FAVLYXA | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 83831-143-01 | ML - Milliliter | 83831-143 | 07f73d6a-4572-459a-bb04-0856a68eb8a5 | 1 | 2026-05-22 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2738672 | FAVLYXA 250 MG in 10 ML Injection | PSN | 1daf714b-704c-4bcc-b6e0-6f0eb2bfe66b | 2 |
| 2738666 | fluorouracil 250 MG in 10 ML Injection | PSN | 1daf714b-704c-4bcc-b6e0-6f0eb2bfe66b | 2 |
| 2738672 | 10 ML fluorouracil 25 MG/ML Injection [Favlyxa] | SBD | 1daf714b-704c-4bcc-b6e0-6f0eb2bfe66b | 2 |
| 2738666 | 10 ML fluorouracil 25 MG/ML Injection | SCD | 1daf714b-704c-4bcc-b6e0-6f0eb2bfe66b | 2 |
| 2738666 | 10 ML 5-5-fluorouracil 25 MG/ML Injection | SY | 1daf714b-704c-4bcc-b6e0-6f0eb2bfe66b | 2 |
| 2738672 | 10 ML 5-5-fluorouracil 25 MG/ML Injection [Favlyxa] | SY | 1daf714b-704c-4bcc-b6e0-6f0eb2bfe66b | 2 |
| 2738666 | 10 ML 5-FU 25 MG/ML Injection | SY | 1daf714b-704c-4bcc-b6e0-6f0eb2bfe66b | 2 |
| 2738672 | 10 ML 5-FU 25 MG/ML Injection [Favlyxa] | SY | 1daf714b-704c-4bcc-b6e0-6f0eb2bfe66b | 2 |
| 2738672 | Favlyxa 25 MG/ML per 10 ML Injection | SY | 1daf714b-704c-4bcc-b6e0-6f0eb2bfe66b | 2 |
| 2738672 | Favlyxa 250 MG per 10 ML Injection | SY | 1daf714b-704c-4bcc-b6e0-6f0eb2bfe66b | 2 |
| 2738666 | fluorouracil 25 MG/ML per 10 ML Injection | SY | 1daf714b-704c-4bcc-b6e0-6f0eb2bfe66b | 2 |
| 2738666 | fluorouracil 250 MG per 10 ML Injection | SY | 1daf714b-704c-4bcc-b6e0-6f0eb2bfe66b | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 83831-143-01 | 83831014301 | 1 VIAL, SINGLE-DOSE in 1 CARTON (83831-143-01) / 10 mL in 1 VIAL, SINGLE-DOSE | 2026-04-01 | No | No | Current |