NDC codes

FDA NDC Directory
Product NDC (as listed)72865-136Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72865-0136Add 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
72865-136-017286501360172865013601100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72865-136-01)Marketed from Feb 24, 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 — 54 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
XLCare Pharmaceuticals, Inc.NDC labeler code 72865
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211009
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Central Nervous System Stimulation (Physiologic effect)
Identifiers
Product ID 72865-136_f0d4af9c-1d16-4405-ac11-6c412af320ebSPL ID f0d4af9c-1d16-4405-ac11-6c412af320ebSPL set ID b07150db-fd99-4400-bb83-b3a7544a917aRxCUI 1091155, 1091170, 1091185, 1091210UNII 4B3SC438HIUPC 0372865133019, 0372865135013, 0372865136010, 0372865134016

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

N472865013601 followed by a unit qualifier and the quantity

Package 72865-0136-01. 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 is 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 me…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72865-136

What is NDC 72865-136?
72865-136 is the product NDC for Methylphenidate Hydrochloride, Methylphenidate hydrochloride 54 mg/1 tablet, extended release, listed with the FDA by XLCare Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Methylphenidate Hydrochloride.
What is the active ingredient?
Methylphenidate hydrochloride.
Who is the labeler?
XLCare Pharmaceuticals, Inc., NDC labeler code 72865. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Methylphenidate Hydrochloride?
148 other product NDCs are listed under this name. See all Methylphenidate Hydrochloride 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 Methylphenidate Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Methylphenidate HydrochlorideMethylphenidate hydrochloride 72 mg/1Tablet, Extended releaseOralNorthstar Rx LLC72603-39972603-0399-01
Methylphenidate HydrochlorideMethylphenidate hydrochloride 72 mg/1Tablet, Extended releaseOralSun Pharmaceutical Industries, Inc.57664-71057664-0710-8357664-0710-88
Methylphenidate HydrochlorideMethylphenidate hydrochloride 10 mg/1TabletOralBryant Ranch Prepack71335-296871335-2968-01
Methylphenidate HydrochlorideMethylphenidate hydrochloride 5 mg/1TabletOralNivagen Pharmaceuticals, Inc.75834-32475834-0324-01
Methylphenidate HydrochlorideMethylphenidate hydrochloride 10 mg/1TabletOralNivagen Pharmaceuticals, Inc.75834-32575834-0325-01
Methylphenidate HydrochlorideMethylphenidate hydrochloride 20 mg/1TabletOralNivagen Pharmaceuticals, Inc.75834-32675834-0326-01
Methylphenidate HydrochlorideMethylphenidate hydrochloride 5 mg/1TabletOralBryant Ranch Prepack72162-242872162-2428-01
Methylphenidate HydrochlorideMethylphenidate hydrochloride 10 mg/1TabletOralBryant Ranch Prepack72162-242972162-2429-01
Methylphenidate HydrochlorideMethylphenidate hydrochloride 20 mg/1TabletOralBryant Ranch Prepack72162-243072162-2430-01
Methylphenidate HydrochlorideMethylphenidate hydrochloride 63 mg/1Tablet, Extended releaseOralTrigen Laboratories, LLC13811-70013811-0700-30

All 149 Methylphenidate Hydrochloride NDCs

Other NDCs under ANDA 211009

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

FDA NDC Directory listings under ANDA 211009
ProductStrengthForm · routeLabelerProduct NDC
Methylphenidate HydrochlorideMethylphenidate hydrochloride 18 mg/1Tablet, Extended releaseOralCamber Pharmaceuticals, Inc.31722-952
Methylphenidate HydrochlorideMethylphenidate hydrochloride 27 mg/1Tablet, Extended releaseOralCamber Pharmaceuticals, Inc.31722-953
Methylphenidate HydrochlorideMethylphenidate hydrochloride 36 mg/1Tablet, Extended releaseOralCamber Pharmaceuticals, Inc.31722-954
Methylphenidate HydrochlorideMethylphenidate hydrochloride 54 mg/1Tablet, Extended releaseOralCamber Pharmaceuticals, Inc.31722-955
Methylphenidate HydrochlorideMethylphenidate hydrochloride 18 mg/1Tablet, Extended releaseOralAmerican Health Packaging60687-532
Methylphenidate HydrochlorideMethylphenidate hydrochloride 27 mg/1Tablet, Extended releaseOralAmerican Health Packaging60687-543
Methylphenidate HydrochlorideMethylphenidate hydrochloride 36 mg/1Tablet, Extended releaseOralAmerican Health Packaging60687-554
Methylphenidate HydrochlorideMethylphenidate hydrochloride 54 mg/1Tablet, Extended releaseOralAmerican Health Packaging60687-565
Methylphenidate HydrochlorideMethylphenidate hydrochloride 18 mg/1Tablet, Extended releaseOralXLCare Pharmaceuticals, Inc.72865-133
Methylphenidate HydrochlorideMethylphenidate hydrochloride 27 mg/1Tablet, Extended releaseOralXLCare Pharmaceuticals, Inc.72865-134
Methylphenidate HydrochlorideMethylphenidate hydrochloride 36 mg/1Tablet, Extended releaseOralXLCare Pharmaceuticals, Inc.72865-135

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