ADHANSIA XR is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Adlon Therapeutics L.p.. The primary component is Methylphenidate Hydrochloride.
Product ID | 72912-525_032a9e34-904e-b736-ba3a-59dbf8ba0f75 |
NDC | 72912-525 |
Product Type | Human Prescription Drug |
Proprietary Name | ADHANSIA XR |
Generic Name | Methylphenidate Hydrochloride |
Dosage Form | Capsule, Extended Release |
Route of Administration | ORAL |
Marketing Start Date | 2019-07-01 |
Marketing Category | NDA / NDA |
Application Number | NDA212038 |
Labeler Name | Adlon Therapeutics L.P. |
Substance Name | METHYLPHENIDATE HYDROCHLORIDE |
Active Ingredient Strength | 25 mg/1 |
Pharm Classes | Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] |
DEA Schedule | CII |
NDC Exclude Flag | N |
Listing Certified Through | 2022-12-31 |
Marketing Start Date | 2019-07-01 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA212038 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2019-07-01 |
Marketing Category | NDA |
Application Number | NDA212038 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2019-07-01 |
Marketing End Date | 2019-07-10 |
Ingredient | Strength |
---|---|
METHYLPHENIDATE HYDROCHLORIDE | 25 mg/1 |
SPL SET ID: | 80e15bd0-4d56-75f0-ab5a-885879fc56e9 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI | |
UPC Code |
NDC | Brand Name | Generic Name |
---|---|---|
72912-535 | ADHANSIA XR | ADHANSIA XR |
72912-570 | ADHANSIA XR | ADHANSIA XR |
72912-555 | ADHANSIA XR | ADHANSIA XR |
72912-585 | ADHANSIA XR | ADHANSIA XR |
72912-525 | ADHANSIA XR | ADHANSIA XR |
72912-545 | ADHANSIA XR | ADHANSIA XR |
0093-3230 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride |
0093-3231 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride |
0093-3232 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride |
0078-0370 | Ritalin | methylphenidate hydrochloride |
0078-0371 | Ritalin | methylphenidate hydrochloride |
0078-0372 | Ritalin | methylphenidate hydrochloride |
0078-0424 | Ritalin | methylphenidate hydrochloride |
0078-0439 | Ritalin | methylphenidate hydrochloride |
0078-0440 | Ritalin | methylphenidate hydrochloride |
0078-0441 | Ritalin | methylphenidate hydrochloride |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ADHANSIA XR 87982478 not registered Live/Pending |
PURDUE PHARMA L.P. 2018-01-16 |
ADHANSIA XR 87756623 not registered Live/Pending |
PURDUE PHARMA L.P. 2018-01-16 |