Methylphenidate Hydrochloride NDC 43598-440

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-440Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0440Add 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 NDC	11-digit (billing)	Package	Copy
43598-440-01	43598044001	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-440-01)Marketed from Aug 20, 2020

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 — 36 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Dr.Reddys Laboratories Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213473
Marketing start: Aug 20, 2020
Marketing end: Sep 30, 2026
DEA schedule: CII
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)
Identifiers: Product ID 43598-440_528a86ce-1037-944a-e934-15846984dd73SPL ID 528a86ce-1037-944a-e934-15846984dd73SPL set ID 7124df7e-6273-a68d-6e35-dc06122d8686RxCUI 1091155, 1091170, 1091185, 1091210UNII 4B3SC438HI
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

N443598044001 followed by a unit qualifier and the quantity

Package 43598-0440-01. 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 Dec 3, 2021. This label includes a boxed warning.

Indications (excerpt from the label)

Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65 [see Clinical Studies ( 14 )] . A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another…

Excerpt only. Read the full label for complete information.

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