Prescription drug · ANDA
Dexmethylphenidate Hydrochloride Extended-Release (Dexmethylphenidate hydrochloride) NDC 0527-8113
Dexmethylphenidate hydrochloride 40 mg/1 · Capsule, Extended release · Oral · Lannett Company, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0527-8113-37 | 00527811337 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-8113-37)Marketed from Oct 9, 2018 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 Extended-ReleaseSuffix: Extended-Release
- Generic name (nonproprietary)
- dexmethylphenidate hydrochloride
- Active ingredients
- Dexmethylphenidate hydrochloride — 40 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Lannett Company, Inc.NDC labeler code 0527
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210279
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 0527-8113_05dde601-77db-4253-be20-c4737687633eSPL ID 05dde601-77db-4253-be20-c4737687633eSPL set ID edad7c67-a872-41ad-a8bd-169278693cc2RxCUI 899439, 899461, 899485, 899495, 899511, 1006608, 1101926, 1101932UNII 1678OK0E08UPC 0305278113378
- 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
N400527811337followed by a unit qualifier and the quantityPackage 00527-8113-37. 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 HCl extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies ( 14 )] . Dexmethylphenidate HCl 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.
About NDC 0527-8113
- What is NDC 0527-8113?
- 0527-8113 is the product NDC for Dexmethylphenidate Hydrochloride Extended-Release, Dexmethylphenidate hydrochloride 40 mg/1 capsule, extended release, listed with the FDA by Lannett Company, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dexmethylphenidate Hydrochloride Extended-Release (Dexmethylphenidate hydrochloride).
- What is the active ingredient?
- Dexmethylphenidate hydrochloride.
- Who is the labeler?
- Lannett Company, Inc., NDC labeler code 0527. 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 Extended-Release?
- 21 other product NDCs are listed under this name. See all Dexmethylphenidate Hydrochloride Extended-Release 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 Extended-Release 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 Extended-Releasedexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 25 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2731 | 00781-2731-31 |
| Dexmethylphenidate Hydrochloride Extended-Releasedexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2732 | 00781-2732-31 |
| Dexmethylphenidate Hydrochloride Extended-Releasedexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 35 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2733 | 00781-2733-31 |
| Dexmethylphenidate Hydrochloride Extended-Releasedexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 40 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2734 | 00781-2734-31 |
| Dexmethylphenidate Hydrochloride Extended-Releasedexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 5 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2727 | 00781-2727-31 |
| Dexmethylphenidate Hydrochloride Extended-Releasedexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 10 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2728 | 00781-2728-31 |
| Dexmethylphenidate Hydrochloride Extended-Releasedexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 15 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2729 | 00781-2729-31 |
| Dexmethylphenidate Hydrochloride Extended-Releasedexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 20 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2730 | 00781-2730-31 |
| Dexmethylphenidate Hydrochloride Extended-Releasedexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 5 mg/1 | Capsule, Extended releaseOral | Lannett Company, Inc. | 0527-8106 | 00527-8106-37 |
| Dexmethylphenidate Hydrochloride Extended-Releasedexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 10 mg/1 | Capsule, Extended releaseOral | Lannett Company, Inc. | 0527-8107 | 00527-8107-37 |
All 22 Dexmethylphenidate Hydrochloride Extended-Release NDCs
Other NDCs under ANDA 210279
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 Extended-Releasedexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 5 mg/1 | Capsule, Extended releaseOral | Lannett Company, Inc. | 0527-8106 |
| Dexmethylphenidate Hydrochloride Extended-Releasedexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 10 mg/1 | Capsule, Extended releaseOral | Lannett Company, Inc. | 0527-8107 |
| Dexmethylphenidate Hydrochloride Extended-Releasedexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 15 mg/1 | Capsule, Extended releaseOral | Lannett Company, Inc. | 0527-8108 |
| Dexmethylphenidate Hydrochloride Extended-Releasedexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 20 mg/1 | Capsule, Extended releaseOral | Lannett Company, Inc. | 0527-8109 |
| Dexmethylphenidate Hydrochloride Extended-Releasedexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 25 mg/1 | Capsule, Extended releaseOral | Lannett Company, Inc. | 0527-8110 |
| Dexmethylphenidate Hydrochloride Extended-Releasedexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Lannett Company, Inc. | 0527-8111 |
| Dexmethylphenidate Hydrochloride Extended-Releasedexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 35 mg/1 | Capsule, Extended releaseOral | Lannett Company, Inc. | 0527-8112 |