Fluorouracil
- Product NDC
- 70700-186
- 11-digit product format
- 707000186
- Labeler code
- 70700
- Product ID
- 70700-186_4b35b4f1-4de4-42de-e063-6294a90a10ae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluorouracil
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Xiromed LLC
- Application
- ANDA210123
- Marketing category
- ANDA
- Marketing start
- 2021-08-13
- Substance
- FLUOROURACIL
- Active strength
- 50 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
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70700-186-23 | 2026-01-29 | C162847 | 48780-1 | 49896155-c21e-586f-e063-e6dba90add90 | These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Initial U.S. Approval: 1962 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70700-186-22 | Fluorouracil | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | 7 | |
| 70700-186-23 | Fluorouracil | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70700-186-22 | ML - Milliliter | 70700-186 | b1ba05a6-8169-4eea-ac73-a0de39da2c71 | 1 | 2021-09-07 |
| 70700-186-23 | ML - Milliliter | 70700-186 | 4ca061bb-fd3d-4a42-bc5b-a94ae441d95f | 1 | 2021-09-07 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1791736 | fluorouracil 1 GM in 20 ML Injection | PSN | 19735014-c6fb-0a05-c330-2e9389c71216 | 7 |
| 1791701 | fluorouracil 500 MG in 10 ML Injection | PSN | 19735014-c6fb-0a05-c330-2e9389c71216 | 7 |
| 1791701 | 10 ML fluorouracil 50 MG/ML Injection | SCD | 19735014-c6fb-0a05-c330-2e9389c71216 | 7 |
| 1791736 | 20 ML fluorouracil 50 MG/ML Injection | SCD | 19735014-c6fb-0a05-c330-2e9389c71216 | 7 |
| 1791701 | 10 ML 5-5-fluorouracil 50 MG/ML Injection | SY | 19735014-c6fb-0a05-c330-2e9389c71216 | 7 |
| 1791701 | 10 ML 5-FU 50 MG/ML Injection | SY | 19735014-c6fb-0a05-c330-2e9389c71216 | 7 |
| 1791736 | 20 ML 5-5-fluorouracil 50 MG/ML Injection | SY | 19735014-c6fb-0a05-c330-2e9389c71216 | 7 |
| 1791736 | 20 ML 5-FU 50 MG/ML Injection | SY | 19735014-c6fb-0a05-c330-2e9389c71216 | 7 |
| 1791736 | fluorouracil 1 GM per 20 ML Injection | SY | 19735014-c6fb-0a05-c330-2e9389c71216 | 7 |
| 1791701 | fluorouracil 500 MG per 10 ML Injection | SY | 19735014-c6fb-0a05-c330-2e9389c71216 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70700-186-22 | 70700018622 | 10 mL in 1 VIAL | 10 ml | Historical | ||||
| 70700-186-23 | 70700018623 | 10 VIAL in 1 CARTON (70700-186-23) / 10 mL in 1 VIAL (70700-186-22) | 10 vial | 2021-08-13 | 0000-00-00 | No | No | Current |