NDC codes

FDA NDC Directory
Product NDC (as listed)0527-4580Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00527-4580Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0527-4580-3700527458037100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-4580-37)Marketed from Feb 18, 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 — 20 mg/1
Dosage form
Capsule, Extended release
Route
Oral
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 0527-4580_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

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

N400527458037 followed by a unit qualifier and the quantity

Package 00527-4580-37. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021259

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 021259
ProductStrengthForm · routeLabelerProduct NDC
Metadate Cdmethylphenidate hydrochlorideMethylphenidate hydrochloride 20 mg/1Capsule, Extended releaseOralAytu BioPharma, Inc.69654-580
Metadate Cdmethylphenidate hydrochlorideMethylphenidate hydrochloride 10 mg/1Capsule, Extended releaseOralAytu BioPharma, Inc.69654-579
Metadate Cdmethylphenidate hydrochlorideMethylphenidate hydrochloride 60 mg/1Capsule, Extended releaseOralAytu BioPharma, Inc.69654-584
Metadate Cdmethylphenidate hydrochlorideMethylphenidate hydrochloride 30 mg/1Capsule, Extended releaseOralAytu BioPharma, Inc.69654-581
Metadate Cdmethylphenidate hydrochlorideMethylphenidate hydrochloride 40 mg/1Capsule, Extended releaseOralAytu BioPharma, Inc.69654-582
Metadate Cdmethylphenidate hydrochlorideMethylphenidate hydrochloride 50 mg/1Capsule, Extended releaseOralAytu BioPharma, Inc.69654-583
methylphenidate hydrochloride CDmethylphenidate hydrochlorideMethylphenidate hydrochloride 10 mg/1Capsule, Extended releaseOralLannett Company, LLC0527-4579
methylphenidate hydrochloride CDmethylphenidate hydrochlorideMethylphenidate hydrochloride 30 mg/1Capsule, Extended releaseOralLannett Company, LLC0527-4581
Metadate Cdmethylphenidate hydrochlorideMethylphenidate hydrochloride 10 mg/1Capsule, Extended releaseOralLannett Company, LLC0527-6579
Metadate Cdmethylphenidate hydrochlorideMethylphenidate hydrochloride 20 mg/1Capsule, Extended releaseOralLannett Company, LLC0527-6580
methylphenidate hydrochloride CDmethylphenidate hydrochlorideMethylphenidate hydrochloride 40 mg/1Capsule, Extended releaseOralLannett Company, LLC0527-4582
methylphenidate hydrochloride CDmethylphenidate hydrochlorideMethylphenidate hydrochloride 50 mg/1Capsule, Extended releaseOralLannett Company, LLC0527-4583
Metadate Cdmethylphenidate hydrochlorideMethylphenidate hydrochloride 30 mg/1Capsule, Extended releaseOralLannett Company, LLC0527-6581
Metadate Cdmethylphenidate hydrochlorideMethylphenidate hydrochloride 40 mg/1Capsule, Extended releaseOralLannett Company, LLC0527-6582
methylphenidate hydrochloride CDmethylphenidate hydrochlorideMethylphenidate hydrochloride 60 mg/1Capsule, Extended releaseOralLannett Company, LLC0527-4584
Metadate Cdmethylphenidate hydrochlorideMethylphenidate hydrochloride 50 mg/1Capsule, Extended releaseOralLannett Company, LLC0527-6583
Metadate Cdmethylphenidate hydrochlorideMethylphenidate hydrochloride 60 mg/1Capsule, Extended releaseOralLannett Company, LLC0527-6584

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