Prescription drug · ANDA
Dexmethylphenidate Hydrochloride NDC 31722-234
Dexmethylphenidate hydrochloride 30 mg/1 · Capsule, Extended release · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-234-01 | 31722023401 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-234-01)Marketed from Dec 8, 2021 |
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 — 30 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215523
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 31722-234_81c8ba81-82ac-4c18-b28b-da9c71520f35SPL ID 81c8ba81-82ac-4c18-b28b-da9c71520f35SPL set ID 77659abe-74be-4092-90fe-cc475726d4ecRxCUI 899439, 899461, 899485, 899495, 899511, 1006608, 1101926, 1101932UNII 1678OK0E08UPC 0331722233019, 0331722229012, 0331722234016, 0331722235013, 0331722231015, 0331722236010, 0331722232012, 0331722230018
- 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
N431722023401followed by a unit qualifier and the quantityPackage 31722-0234-01. 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 extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)] . Dexmethylphenidate hydrochloride extended-release capsules 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 215523
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 10 mg/1 | Capsule, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-230 |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 5 mg/1 | Capsule, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-229 |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 25 mg/1 | Capsule, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-233 |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 15 mg/1 | Capsule, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-231 |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 20 mg/1 | Capsule, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-232 |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 35 mg/1 | Capsule, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-235 |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 40 mg/1 | Capsule, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-236 |