Prescription drug · ANDA
Dexmethylphenidate Hydrochloride NDC 43386-861
Dexmethylphenidate hydrochloride 10 mg/1 · Tablet · Oral · Lupin Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43386-861-01 | 4338608610143386086101 | 100 TABLET in 1 BOTTLE (43386-861-01)Marketed from Dec 4, 2015 |
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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals,Inc.NDC labeler code 43386
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204534
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 43386-861_4d2d72fd-412e-4556-9adc-d4673576a29cSPL ID 4d2d72fd-412e-4556-9adc-d4673576a29cSPL set ID a61932ef-c2b6-4363-a21d-1f0358f317b6RxCUI 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
N443386086101followed by a unit qualifier and the quantityPackage 43386-0861-01. 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 tablet 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.
About NDC 43386-861
- What is NDC 43386-861?
- 43386-861 is the product NDC for Dexmethylphenidate Hydrochloride, Dexmethylphenidate hydrochloride 10 mg/1 tablet, listed with the FDA by Lupin Pharmaceuticals,Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dexmethylphenidate Hydrochloride.
- What is the active ingredient?
- Dexmethylphenidate hydrochloride.
- Who is the labeler?
- Lupin Pharmaceuticals,Inc., NDC labeler code 43386. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dexmethylphenidate Hydrochloride?
- 72 other product NDCs are listed under this name. See all Dexmethylphenidate Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dexmethylphenidate Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2426 | 72162-2426-0172162-2426-06 |
| Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2427 | 72162-2427-01 |
| Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 5 mg/1 | TabletOral | Nivagen Pharmaceuticals, Inc. | 75834-327 | 75834-0327-01 |
| Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 10 mg/1 | TabletOral | Nivagen Pharmaceuticals, Inc. | 75834-328 | 75834-0328-01 |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 5 mg/1 | Capsule, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-229 | 31722-0229-01 |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 10 mg/1 | Capsule, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-230 | 31722-0230-01 |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 15 mg/1 | Capsule, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-231 | 31722-0231-01 |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 20 mg/1 | Capsule, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-232 | 31722-0232-01 |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 25 mg/1 | Capsule, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-233 | 31722-0233-01 |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-234 | 31722-0234-01 |
Other NDCs under ANDA 204534
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 | Lupin Pharmaceuticals,Inc. | 43386-860 |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 2.5 mg/1 | TabletOral | Lupin Pharmaceuticals,Inc. | 43386-862 |