Prescription drug · ANDA
Methylphenidate Hydrochloride NDC 72865-135
Methylphenidate hydrochloride 36 mg/1 · Tablet, Extended release · Oral · XLCare Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72865-135-01 | 72865013501 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72865-135-01)Marketed from Feb 24, 2020 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Methylphenidate Hydrochloride
- Generic name (nonproprietary)
- methylphenidate hydrochloride
- Active ingredients
- Methylphenidate hydrochloride — 36 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- XLCare Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211009
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 72865-135_f0d4af9c-1d16-4405-ac11-6c412af320ebSPL ID f0d4af9c-1d16-4405-ac11-6c412af320ebSPL set ID b07150db-fd99-4400-bb83-b3a7544a917aRxCUI 1091155, 1091170, 1091185, 1091210UNII 4B3SC438HIUPC 0372865133019, 0372865135013, 0372865136010, 0372865134016
- Pharmacologic class
- Central Nervous System Stimulant
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N472865013501followed by a unit qualifier and the quantityPackage 72865-0135-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Methylphenidate hydrochloride extended-release tablets is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65 [see Clinical Studies (14)] . A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another me…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211009
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 18 mg/1 | Tablet, Extended releaseOral | American Health Packaging | 60687-532 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 27 mg/1 | Tablet, Extended releaseOral | American Health Packaging | 60687-543 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 36 mg/1 | Tablet, Extended releaseOral | American Health Packaging | 60687-554 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 18 mg/1 | Tablet, Extended releaseOral | XLCare Pharmaceuticals, Inc. | 72865-133 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 27 mg/1 | Tablet, Extended releaseOral | XLCare Pharmaceuticals, Inc. | 72865-134 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 54 mg/1 | Tablet, Extended releaseOral | XLCare Pharmaceuticals, Inc. | 72865-136 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 18 mg/1 | Tablet, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-952 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 27 mg/1 | Tablet, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-953 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 36 mg/1 | Tablet, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-954 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 54 mg/1 | Tablet, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-955 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 54 mg/1 | Tablet, Extended releaseOral | American Health Packaging | 60687-565 |