Modafinil is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Viona Pharmaceuticals Inc. The primary component is Modafinil.
| Product ID | 72578-005_16e4e243-a7de-40c0-8991-2244d78f9361 |
| NDC | 72578-005 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Modafinil |
| Generic Name | Modafinil |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2019-02-15 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA209966 |
| Labeler Name | Viona Pharmaceuticals Inc |
| Substance Name | MODAFINIL |
| Active Ingredient Strength | 100 mg/1 |
| Pharm Classes | Central Nervous System Stimulation [PE], Increased Sympathetic Activity [PE], Sympathomimetic-like Agent [EPC] |
| DEA Schedule | CIV |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2019-02-15 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA209966 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-02-15 |
| Marketing Category | ANDA |
| Application Number | ANDA209966 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-02-15 |
| Marketing Category | ANDA |
| Application Number | ANDA209966 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-02-15 |
| Ingredient | Strength |
|---|---|
| MODAFINIL | 100 mg/1 |
| SPL SET ID: | 15739a31-2433-49b5-90ea-b974214f73be |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0143-9968 | Modafinil | modafinil |
| 0143-9969 | Modafinil | modafinil |
| 0378-5573 | Modafinil | modafinil |
| 0378-5575 | Modafinil | modafinil |
| 0591-3499 | Modafinil | Modafinil |
| 0591-3500 | Modafinil | Modafinil |
| 0904-6423 | Modafinil | Modafinil |
| 0904-6424 | Modafinil | Modafinil |
| 0904-6791 | Modafinil | modafinil |
| 0904-6792 | Modafinil | modafinil |
| 23155-604 | Modafinil | Modafinil |
| 23155-605 | Modafinil | Modafinil |
| 42043-160 | Modafinil | Modafinil |
| 42043-161 | Modafinil | Modafinil |
| 42291-599 | Modafinil | Modafinil |
| 42291-600 | Modafinil | Modafinil |
| 43353-831 | Modafinil | modafinil |
| 43353-925 | modafinil | modafinil |
| 43353-956 | Modafinil | Modafinil |
| 46708-385 | Modafinil | Modafinil |
| 46708-386 | Modafinil | Modafinil |
| 49884-534 | Modafinil | Modafinil |
| 68084-721 | Modafinil | Modafinil |
| 68084-621 | Modafinil | Modafinil |
| 68258-7981 | modafinil | modafinil |
| 68788-7408 | Modafinil | Modafinil |
| 70710-1073 | Modafinil | Modafinil |
| 70710-1072 | Modafinil | Modafinil |
| 70771-1051 | Modafinil | Modafinil |
| 70771-1052 | Modafinil | Modafinil |
| 71335-0259 | Modafinil | Modafinil |
| 71335-0811 | Modafinil | Modafinil |
| 71335-0997 | Modafinil | Modafinil |
| 72578-005 | Modafinil | Modafinil |
| 72578-006 | Modafinil | Modafinil |
| 49884-535 | Modafinil | Modafinil |
| 50090-2472 | Modafinil | Modafinil |
| 50090-2473 | Modafinil | Modafinil |
| 50090-3865 | Modafinil | Modafinil |
| 50268-570 | Modafinil | Modafinil |
| 50090-4144 | Modafinil | Modafinil |
| 50268-571 | Modafinil | Modafinil |
| 50742-153 | Modafinil | Modafinil |
| 50742-152 | Modafinil | Modafinil |
| 51079-561 | Modafinil | Modafinil |
| 51079-562 | Modafinil | Modafinil |
| 55253-801 | Modafinil | Modafinil |
| 55253-802 | Modafinil | Modafinil |
| 55700-695 | Modafinil | Modafinil |
| 55700-688 | Modafinil | Modafinil |