Prescription drug · ANDA
Dexmethylphenidate Hydrochloride NDC 67877-655
Dexmethylphenidate hydrochloride 2.5 mg/1 · Tablet · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-655-01 | 67877065501 | 100 TABLET in 1 BOTTLE (67877-655-01)Marketed from Jul 21, 2019 | |
| 67877-655-05 | 67877065505 | 500 TABLET in 1 BOTTLE (67877-655-05)Marketed from Jul 21, 2019 | |
| 67877-655-30 | 67877065530 | 30 TABLET in 1 BOTTLE (67877-655-30)Marketed from Jul 21, 2019 |
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)
- Dexmethylphenidate Hydrochloride
- Generic name (nonproprietary)
- dexmethylphenidate hydrochloride
- Active ingredients
- Dexmethylphenidate hydrochloride — 2.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Ascend Laboratories, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212631
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 67877-655_d87ba2c9-5dd1-4038-8149-7ef46c421422SPL ID d87ba2c9-5dd1-4038-8149-7ef46c421422SPL set ID 830df993-db01-40df-beef-90af6b86f561RxCUI 899518, 899548, 899557UNII 1678OK0E08
- 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
N467877065501followed by a unit qualifier and the quantityPackage 67877-0655-01. 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)
Dexmethylphenidate hydrochloride is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies ( 14 )] . Dexmethylphenidate hydrochloride is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) (1).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212631
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 |
|---|---|---|---|---|
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 5 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-656 |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 10 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-657 |