Prescription drug · ANDA
Methylphenidate Hydrochloride NDC 60687-532
Methylphenidate hydrochloride 18 mg/1 · Tablet, Extended release · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-532-21 | 60687053221 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-532-21) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (60687-532-11)Marketed from Jun 25, 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 — 18 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- American Health Packaging
- 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 60687-532_4522b794-5c43-44cd-e063-6394a90ab39aSPL ID 4522b794-5c43-44cd-e063-6394a90ab39aSPL set ID f6581305-cd1e-4171-8c1b-e184c7bde033RxCUI 1091155, 1091170, 1091185, 1091210UNII 4B3SC438HI
- 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
N460687053221followed by a unit qualifier and the quantityPackage 60687-0532-21. 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) ]. Methylphenidate hydrochloride extended-release tablets is a CNS stimulant 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. (1)
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 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 36 mg/1 | Tablet, Extended releaseOral | XLCare Pharmaceuticals, Inc. | 72865-135 |
| 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 |