Prescription drug · NDA AUTHORIZED GENERIC
methylphenidate hydrochloride CD (Methylphenidate hydrochloride) NDC 0527-4579
Methylphenidate hydrochloride 10 mg/1 · Capsule, Extended release · Oral · Lannett Company, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0527-4579-37 | 0052745793700527457937 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-4579-37)Marketed from Aug 12, 2003 |
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)
- methylphenidate hydrochloride CD
- Generic name (nonproprietary)
- methylphenidate hydrochloride
- Active ingredients
- Methylphenidate hydrochloride — 10 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Lannett Company, LLCNDC labeler code 0527
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021259
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 0527-4579_06870e9a-5f34-475f-be00-04b9eabe940eSPL ID 06870e9a-5f34-475f-be00-04b9eabe940eSPL set ID e45c75dc-d381-475b-b649-a871c8a36e60RxCUI 1806181, 1806187, 1806189, 1806191, 1806193, 1806197UNII 4B3SC438HIUPC 0305274579376, 0305274580372, 0305274582376, 0305274584370
- 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
N400527457937followed by a unit qualifier and the quantityPackage 00527-4579-37. 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)
Methylphenidate HCl Extended-Release Capsules CD is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. Limitations of Use The use of Methylphenidate HCl Extended-Release Capsules CD is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions ( 5.7 ), Use in Specific Populations ( 8.4 )] . Methylphenidate HCl Extended-Release Capsules CD is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyp…
Excerpt only. Read the full label for complete information.
About NDC 0527-4579
- What is NDC 0527-4579?
- 0527-4579 is the product NDC for methylphenidate hydrochloride CD (methylphenidate hydrochloride), Methylphenidate hydrochloride 10 mg/1 capsule, extended release, listed with the FDA by Lannett Company, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- methylphenidate hydrochloride CD (Methylphenidate hydrochloride).
- What is the active ingredient?
- Methylphenidate hydrochloride.
- Who is the labeler?
- Lannett Company, LLC, 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 methylphenidate hydrochloride CD?
- 5 other product NDCs are listed under this name. See all methylphenidate hydrochloride CD NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other methylphenidate hydrochloride CD products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| methylphenidate hydrochloride CDmethylphenidate hydrochloride | Methylphenidate hydrochloride 40 mg/1 | Capsule, Extended releaseOral | Lannett Company, LLC | 0527-4582 | 00527-4582-37 |
| methylphenidate hydrochloride CDmethylphenidate hydrochloride | Methylphenidate hydrochloride 50 mg/1 | Capsule, Extended releaseOral | Lannett Company, LLC | 0527-4583 | 00527-4583-37 |
| methylphenidate hydrochloride CDmethylphenidate hydrochloride | Methylphenidate hydrochloride 60 mg/1 | Capsule, Extended releaseOral | Lannett Company, LLC | 0527-4584 | 00527-4584-37 |
| methylphenidate hydrochloride CDmethylphenidate hydrochloride | Methylphenidate hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Lannett Company, LLC | 0527-4581 | 00527-4581-37 |
| methylphenidate hydrochloride CDmethylphenidate hydrochloride | Methylphenidate hydrochloride 20 mg/1 | Capsule, Extended releaseOral | Lannett Company, LLC | 0527-4580 | 00527-4580-37 |
Other NDCs under NDA 021259
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 |
|---|---|---|---|---|
| Metadate Cdmethylphenidate hydrochloride | Methylphenidate hydrochloride 10 mg/1 | Capsule, Extended releaseOral | Lannett Company, LLC | 0527-6579 |
| Metadate Cdmethylphenidate hydrochloride | Methylphenidate hydrochloride 20 mg/1 | Capsule, Extended releaseOral | Lannett Company, LLC | 0527-6580 |
| Metadate Cdmethylphenidate hydrochloride | Methylphenidate hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Lannett Company, LLC | 0527-6581 |
| Metadate Cdmethylphenidate hydrochloride | Methylphenidate hydrochloride 40 mg/1 | Capsule, Extended releaseOral | Lannett Company, LLC | 0527-6582 |
| Metadate Cdmethylphenidate hydrochloride | Methylphenidate hydrochloride 50 mg/1 | Capsule, Extended releaseOral | Lannett Company, LLC | 0527-6583 |
| Metadate Cdmethylphenidate hydrochloride | Methylphenidate hydrochloride 60 mg/1 | Capsule, Extended releaseOral | Lannett Company, LLC | 0527-6584 |
| Metadate Cdmethylphenidate hydrochloride | Methylphenidate hydrochloride 10 mg/1 | Capsule, Extended releaseOral | Aytu BioPharma, Inc. | 69654-579 |
| Metadate Cdmethylphenidate hydrochloride | Methylphenidate hydrochloride 20 mg/1 | Capsule, Extended releaseOral | Aytu BioPharma, Inc. | 69654-580 |
| Metadate Cdmethylphenidate hydrochloride | Methylphenidate hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Aytu BioPharma, Inc. | 69654-581 |
| Metadate Cdmethylphenidate hydrochloride | Methylphenidate hydrochloride 40 mg/1 | Capsule, Extended releaseOral | Aytu BioPharma, Inc. | 69654-582 |
| Metadate Cdmethylphenidate hydrochloride | Methylphenidate hydrochloride 50 mg/1 | Capsule, Extended releaseOral | Aytu BioPharma, Inc. | 69654-583 |
| Metadate Cdmethylphenidate hydrochloride | Methylphenidate hydrochloride 60 mg/1 | Capsule, Extended releaseOral | Aytu BioPharma, Inc. | 69654-584 |
| methylphenidate hydrochloride CDmethylphenidate hydrochloride | Methylphenidate hydrochloride 20 mg/1 | Capsule, Extended releaseOral | Lannett Company, LLC | 0527-4580 |
| methylphenidate hydrochloride CDmethylphenidate hydrochloride | Methylphenidate hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Lannett Company, LLC | 0527-4581 |
| methylphenidate hydrochloride CDmethylphenidate hydrochloride | Methylphenidate hydrochloride 40 mg/1 | Capsule, Extended releaseOral | Lannett Company, LLC | 0527-4582 |
| methylphenidate hydrochloride CDmethylphenidate hydrochloride | Methylphenidate hydrochloride 50 mg/1 | Capsule, Extended releaseOral | Lannett Company, LLC | 0527-4583 |
| methylphenidate hydrochloride CDmethylphenidate hydrochloride | Methylphenidate hydrochloride 60 mg/1 | Capsule, Extended releaseOral | Lannett Company, LLC | 0527-4584 |