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NDC 68025-0709-10 RELEXXII 54 mg/1 Details
RELEXXII 54 mg/1
RELEXXII is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Vertical Pharmaceuticals, LLC. The primary component is METHYLPHENIDATE HYDROCHLORIDE.
Product Information
| NDC | 68025-0709 |
|---|---|
| Product ID | 68025-709_08f3dcf5-5d5e-f4ec-e063-6394a90a1ee8 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | RELEXXII |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | methylphenidate hydrochloride extended-release |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 54 |
| Active Ingredient Units | mg/1 |
| Substance Name | METHYLPHENIDATE HYDROCHLORIDE |
| Labeler Name | Vertical Pharmaceuticals, LLC |
| Pharmaceutical Class | Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE] |
| DEA Schedule | CII |
| Marketing Category | NDA |
| Application Number | NDA216117 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 68025-0709-10 (68025070910)
| NDC Package Code | 68025-709-10 |
|---|---|
| Billing NDC | 68025070910 |
| Package | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-709-10) |
| Marketing Start Date | 2023-11-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |