Fentanyl Citrate
- Product NDC
- 63323-808
- 11-digit product format
- 633230808
- Labeler code
- 63323
- Product ID
- 63323-808_a47a3a31-e293-49d5-b6bc-950303525a64
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fentanyl Citrate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA212086
- Marketing category
- ANDA
- Marketing start
- 2020-09-30
- Substance
- FENTANYL CITRATE
- Active strength
- 50 ug/mL
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fentanyl Citrate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FENTANYL CITRATE | 50 ug/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | MUN5LYG46H |
| Rxcui | 2474267, 2474269 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-808-01 | Fentanyl Citrate | 1 mL in 1 SYRINGE | INJECTION, SOLUTION | 1 | | 6 |
| 63323-808-11 | Fentanyl Citrate | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-808 | FENTANYL CITRATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240117_0c10e465-4117-48ba-a454-23ccb7a3fcc7.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 |
|---|
| 63323-808-01 | 63323080801 | 1 mL in 1 SYRINGE | 1 ml | | | | | Historical |
| 63323-808-11 | 63323080811 | 10 SYRINGE in 1 CARTON (63323-808-11) / 1 mL in 1 SYRINGE (63323-808-01) | 10 syringe | 2020-09-30 | 0000-00-00 | No | No | Current |