NDC codes

FDA NDC Directory
Product NDC (as listed)64980-221Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64980-0221Add 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
64980-221-0164980022101100 TABLET, CHEWABLE in 1 BOTTLE (64980-221-01)Marketed from Dec 18, 2018

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)
Methylphenidate Hydrochloride
Generic name (nonproprietary)
methylphenidate hydrochloride
Active ingredients
Methylphenidate hydrochloride — 2.5 mg/1
Dosage form
Tablet, Chewable
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205756
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Central Nervous System Stimulation (Physiologic effect)
Identifiers
Product ID 64980-221_85d614b0-888e-461f-bc7d-3f240ed8bd0eSPL ID 85d614b0-888e-461f-bc7d-3f240ed8bd0eSPL set ID e5cb0740-813f-4dce-8c29-d7680c66e77cRxCUI 1091152, 1091322, 1091389UNII 4B3SC438HI

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

N464980022101 followed by a unit qualifier and the quantity

Package 64980-0221-01. 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)

Methylphenidate Hydrochloride Chewable Tablets is indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older Narcolepsy Methylphenidate Hydrochloride Chewable Tablets are a central nervous system (CNS) stimulant indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older ( 1 ) Narcolepsy ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205756

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

FDA NDC Directory listings under ANDA 205756
ProductStrengthForm · routeLabelerProduct NDC
Methylphenidate HydrochlorideMethylphenidate hydrochloride 5 mg/1Tablet, ChewableOralRising Pharma Holdings, Inc.64980-222
Methylphenidate HydrochlorideMethylphenidate hydrochloride 10 mg/1Tablet, ChewableOralRising Pharma Holdings, Inc.64980-223

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