Prescription drug · ANDA
Dexmethylphenidate Hydrochloride NDC 27808-092
Dexmethylphenidate hydrochloride 5 mg/1 · Tablet · Oral · Cranbury Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 27808-092-01 | 27808009201 | 100 TABLET in 1 BOTTLE (27808-092-01)Marketed from Nov 30, 2001 |
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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207901
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 27808-092_9e21f04a-b4b6-45b8-8da3-5955e6aa18a5SPL ID 9e21f04a-b4b6-45b8-8da3-5955e6aa18a5SPL set ID 1f2aa66a-51dc-459c-a765-5364bccd310fRxCUI 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
N427808009201followed by a unit qualifier and the quantityPackage 27808-0092-01. 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 tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies ( 14 )] . Dexmethylphenidate hydrochloride tablets are 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 207901
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 2.5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1284 |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1285 |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1286 |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2306 |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 2.5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2305 |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2307 |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 2.5 mg/1 | TabletOral | Cranbury Pharmaceuticals, LLC | 27808-091 |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 10 mg/1 | TabletOral | Cranbury Pharmaceuticals, LLC | 27808-093 |