Fentanyl Citrate
- Product NDC
- 81565-205
- 11-digit product format
- 815650205
- Labeler code
- 81565
- Product ID
- 81565-205_09e32400-24f3-4cab-9563-30e9f92dc17d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fentanyl Citrate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Phlow Corp.
- Application
- NDA019101
- Marketing category
- NDA
- Marketing start
- 2023-01-11
- Marketing end
- 2028-06-30
- Substance
- FENTANYL CITRATE
- Active strength
- 50 ug/mL
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fentanyl Citrate
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FENTANYL CITRATE | 50 ug/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | MUN5LYG46H |
| Rxcui | 1735003 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 81565-205-01 | Fentanyl Citrate | 2 mL in 1 VIAL | INJECTION | 2 | | 10 |
| 81565-205-02 | Fentanyl Citrate | 25 in 1 CARTON | INJECTION | 25 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81565-205 | FENTANYL CITRATE INJECTION [PHLOW CORP.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240614_58dcd3f7-e3d8-4929-a186-8f680a51ff11.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 |
|---|
| 81565-205-01 | 81565020501 | 2 mL in 1 VIAL | 2 ml | | | | | Historical |
| 81565-205-02 | 81565020502 | 25 VIAL in 1 CARTON (81565-205-02) / 2 mL in 1 VIAL (81565-205-01) | 25 vial | 2023-01-11 | 2028-06-30 | No | No | Current |