NDC codes

FDA NDC Directory
Product NDC (as listed)62037-734Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62037-0734Add 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
62037-734-0162037073401100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62037-734-01)Marketed from Mar 4, 2019

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 — 27 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076772
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Central Nervous System Stimulation (Physiologic effect)
Identifiers
Product ID 62037-734_24aa9277-3773-489d-8459-f9215140c53fSPL ID 24aa9277-3773-489d-8459-f9215140c53fSPL set ID 85ef422d-af27-4126-9841-6892af1871d6RxCUI 1091155, 1091170, 1091185, 1091210UNII 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

N462037073401 followed by a unit qualifier and the quantity

Package 62037-0734-01. 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 extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years old. Limitations of Use The use of methylphenidate hydrochloride extended-release tablets are 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 ) and Use in Specific Populations ( 8.4 )]. Methylphenidate hydrochloride extended-release tablets are a CNS stimulant indicated for the treatment of attention deficit hyperactivit…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076772

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

FDA NDC Directory listings under ANDA 076772
ProductStrengthForm · routeLabelerProduct NDC
Methylphenidate HydrochlorideMethylphenidate hydrochloride 18 mg/1Tablet, Film coated, Extended releaseOralActavis Pharma, Inc.62037-725
Methylphenidate HydrochlorideMethylphenidate hydrochloride 36 mg/1Tablet, Film coated, Extended releaseOralActavis Pharma, Inc.62037-726

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