Prescription drug · NDA

Methylin (Methylphenidate hydrochloride) NDC 59630-755

Methylphenidate hydrochloride 10 mg/5mL · Solution · Oral · SHIONOGI INC.

NDC codes

FDA NDC Directory
Product NDC (as listed)59630-755Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59630-0755Add 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
59630-755-5059630075550500 mL in 1 BOTTLE (59630-755-50)Marketed from Dec 19, 2002

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)
Methylin
Generic name (nonproprietary)
methylphenidate hydrochloride
Active ingredients
Methylphenidate hydrochloride — 10 mg/5mL
Dosage form
Solution
Route
Oral
Labeler
SHIONOGI INC.NDC labeler code 59630
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 021419
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Central Nervous System Stimulation (Physiologic effect)
Identifiers
Product ID 59630-755_64c7c464-4ef5-401a-ab3c-c0443e5e31a5SPL ID 64c7c464-4ef5-401a-ab3c-c0443e5e31a5SPL set ID 9e3c22d9-71d9-46a7-b315-8021c94c4becRxCUI 1091133, 1091135, 1091341, 1091343UNII 4B3SC438HIUPC 0359630755508, 0359630750503

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

N459630075550 followed by a unit qualifier and the quantity

Package 59630-0755-50. 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)

Methylin is indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years of age and older Narcolepsy Methylin is a central nervous system (CNS) stimulant indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric 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)

About NDC 59630-755

What is NDC 59630-755?
59630-755 is the product NDC for Methylin (methylphenidate hydrochloride), Methylphenidate hydrochloride 10 mg/5mL solution, listed with the FDA by SHIONOGI INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Methylin (Methylphenidate Hydrochloride).
What is the active ingredient?
Methylphenidate hydrochloride.
Who is the labeler?
SHIONOGI INC., NDC labeler code 59630. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Methylin?
1 other product NDC are listed under this name. See all Methylin NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Methylin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Methylinmethylphenidate hydrochlorideMethylphenidate hydrochloride 5 mg/5mLSolutionOralSHIONOGI INC.59630-75059630-0750-50

Other NDCs under NDA 021419

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

FDA NDC Directory listings under NDA 021419
ProductStrengthForm · routeLabelerProduct NDC
Methylinmethylphenidate hydrochlorideMethylphenidate hydrochloride 5 mg/5mLSolutionOralSHIONOGI INC.59630-750

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Methylin NDC 59630-755 | National Drug Code | Med-Code