Prescription drug · ANDA

Dexmethylphenidate Hydrochloride NDC 49884-049

Dexmethylphenidate hydrochloride 10 mg/1 · Capsule, Extended release · Oral · Par Health USA, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)49884-049Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49884-0049Add 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
49884-049-0149884004901100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (49884-049-01)Marketed from Jan 5, 2017

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)
Dexmethylphenidate Hydrochloride
Generic name (nonproprietary)
dexmethylphenidate hydrochloride
Active ingredients
Dexmethylphenidate hydrochloride — 10 mg/1
Dosage form
Capsule, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202842
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Central Nervous System Stimulation (Physiologic effect)
Identifiers
Product ID 49884-049_09fcee97-8b48-4a1d-a380-0e01c92e0e9bSPL ID 09fcee97-8b48-4a1d-a380-0e01c92e0e9bSPL set ID e304388e-86a6-4335-abae-0ce79c7c99c6RxCUI 899439, 899461, 899485, 899495, 899511, 1006608, 1101926, 1101932UNII 1678OK0E08

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

N449884004901 followed by a unit qualifier and the quantity

Package 49884-0049-01. 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)

Dexmethylphenidate hydrochloride extended-release is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies ( 14 )]. Dexmethylphenidate hydrochloride extended-release is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202842

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

FDA NDC Directory listings under ANDA 202842
ProductStrengthForm · routeLabelerProduct NDC
Dexmethylphenidate HydrochlorideDexmethylphenidate hydrochloride 5 mg/1Capsule, Extended releaseOralPar Health USA, LLC49884-048
Dexmethylphenidate HydrochlorideDexmethylphenidate hydrochloride 20 mg/1Capsule, Extended releaseOralBryant Ranch Prepack63629-2173
Dexmethylphenidate HydrochlorideDexmethylphenidate hydrochloride 20 mg/1Capsule, Extended releaseOralPar Health USA, LLC49884-248
Dexmethylphenidate HydrochlorideDexmethylphenidate hydrochloride 10 mg/1Capsule, Extended releaseOralBryant Ranch Prepack63629-2171
Dexmethylphenidate HydrochlorideDexmethylphenidate hydrochloride 35 mg/1Capsule, Extended releaseOralBryant Ranch Prepack63629-2176
Dexmethylphenidate HydrochlorideDexmethylphenidate hydrochloride 25 mg/1Capsule, Extended releaseOralBryant Ranch Prepack63629-2174
Dexmethylphenidate HydrochlorideDexmethylphenidate hydrochloride 5 mg/1Capsule, Extended releaseOralBryant Ranch Prepack63629-2178
Dexmethylphenidate HydrochlorideDexmethylphenidate hydrochloride 25 mg/1Capsule, Extended releaseOralPar Health USA, LLC49884-333
Dexmethylphenidate HydrochlorideDexmethylphenidate hydrochloride 35 mg/1Capsule, Extended releaseOralPar Health USA, LLC49884-339
Dexmethylphenidate HydrochlorideDexmethylphenidate hydrochloride 40 mg/1Capsule, Extended releaseOralPar Health USA, LLC49884-546
Dexmethylphenidate HydrochlorideDexmethylphenidate hydrochloride 5 mg/1Capsule, Extended releaseOralBryant Ranch Prepack72162-1472
Dexmethylphenidate HydrochlorideDexmethylphenidate hydrochloride 10 mg/1Capsule, Extended releaseOralBryant Ranch Prepack72162-1473
Dexmethylphenidate HydrochlorideDexmethylphenidate hydrochloride 20 mg/1Capsule, Extended releaseOralBryant Ranch Prepack72162-1488
Dexmethylphenidate HydrochlorideDexmethylphenidate hydrochloride 25 mg/1Capsule, Extended releaseOralBryant Ranch Prepack72162-1493
Dexmethylphenidate HydrochlorideDexmethylphenidate hydrochloride 35 mg/1Capsule, Extended releaseOralBryant Ranch Prepack72162-1496
Dexmethylphenidate HydrochlorideDexmethylphenidate hydrochloride 40 mg/1Capsule, Extended releaseOralBryant Ranch Prepack72162-1507

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Dexmethylphenidate Hydrochloride NDC 49884-049 | Med-Code