NDC 57881-333
Abstral
Fentanyl Citrate
Abstral is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Galena Biopharma, Inc.. The primary component is Fentanyl Citrate.
| Product ID | 57881-333_621fd88b-b921-47a2-94bd-a778d6005353 |
| NDC | 57881-333 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Abstral |
| Generic Name | Fentanyl Citrate |
| Dosage Form | Tablet |
| Route of Administration | SUBLINGUAL |
| Marketing Start Date | 2013-08-08 |
| Marketing Category | NDA / NDA |
| Application Number | NDA022510 |
| Labeler Name | Galena Biopharma, Inc. |
| Substance Name | FENTANYL CITRATE |
| Active Ingredient Strength | 300 ug/1 |
| Pharm Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
| DEA Schedule | CII |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 57881-333-32
8 BLISTER PACK in 1 CARTON (57881-333-32) > 4 TABLET in 1 BLISTER PACK (57881-333-04)
| Marketing Start Date | 2013-08-08 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 57881-333-32 [57881033332]
Abstral TABLET
| Marketing Category | NDA |
| Application Number | NDA022510 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2013-08-08 |
| Inactivation Date | 2020-01-31 |
NDC 57881-333-04 [57881033304]
Abstral TABLET
| Marketing Category | NDA |
| Application Number | NDA022510 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2013-08-08 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| FENTANYL CITRATE | 300 ug/1 |
OpenFDA Data
| SPL SET ID: | f969e2bc-6297-4e29-89d3-a3685a2c7c6b |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Full Opioid Agonists [MoA]
- Opioid Agonist [EPC]
NDC Crossover Matching brand name "Abstral" or generic name "Fentanyl Citrate"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 42747-226 | Abstral | Abstral |
| 42747-222 | Abstral | Abstral |
| 42747-224 | Abstral | Abstral |
| 42747-221 | Abstral | Abstral |
| 42747-223 | Abstral | Abstral |
| 42747-228 | Abstral | Abstral |
| 57881-338 | Abstral | Abstral |
| 57881-336 | Abstral | Abstral |
| 57881-332 | Abstral | Abstral |
| 57881-333 | Abstral | Abstral |
| 57881-334 | Abstral | Abstral |
| 57881-331 | Abstral | Abstral |
| 0093-7865 | Fentanyl Citrate | Fentanyl Citrate |
| 0093-7866 | Fentanyl Citrate | Fentanyl Citrate |
| 0093-7867 | Fentanyl Citrate | Fentanyl Citrate |
| 0093-7868 | Fentanyl Citrate | Fentanyl Citrate |
| 0093-7869 | Fentanyl Citrate | Fentanyl Citrate |
| 0093-7870 | Fentanyl Citrate | Fentanyl Citrate |
| 0406-9202 | FENTANYL CITRATE | FENTANYL CITRATE |
Trademark Results [Abstral]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ABSTRAL 77117021 3563010 Live/Registered |
SENTYNL THERAPEUTICS, INC. 2007-02-27 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.