What is NDC 75834-327?

75834-327 is the product NDC for Dexmethylphenidate hydrochloride, Dexmethylphenidate hydrochloride 5 mg/1 tablet, listed with the FDA by Nivagen Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Nivagen Pharmaceuticals, Inc., NDC labeler code 75834. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Dexmethylphenidate hydrochloride?

72 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Dexmethylphenidate hydrochloride NDC 75834-327

NDC codes

FDA NDC Directory

Product NDC (as listed)75834-327Labeler and product segments. Claims need a package NDC.

Product NDC at billing width75834-0327Add 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
75834-327-01	7583403270175834032701	100 TABLET in 1 BOTTLE (75834-327-01)Marketed from May 3, 2024

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 — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Nivagen Pharmaceuticals, Inc.NDC labeler code 75834
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209211
Marketing start: May 3, 2024
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)
Identifiers: Product ID 75834-327_6103914c-da93-4648-9180-e5c439a07bc2SPL ID 6103914c-da93-4648-9180-e5c439a07bc2SPL set ID 638f614c-bf91-4bf6-876f-bf25fa273bc4RxCUI 899518, 899548UNII 1678OK0E08UPC 0375834328010, 0375834327013
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

N475834032701 followed by a unit qualifier and the quantity

Package 75834-0327-01. 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 Jan 1, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 75834-327

What is NDC 75834-327?: 75834-327 is the product NDC for Dexmethylphenidate hydrochloride, Dexmethylphenidate hydrochloride 5 mg/1 tablet, listed with the FDA by Nivagen Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Dexmethylphenidate hydrochloride.
What is the active ingredient?: Dexmethylphenidate hydrochloride.
Who is the labeler?: Nivagen Pharmaceuticals, Inc., NDC labeler code 75834. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dexmethylphenidate hydrochloride?: 72 other product NDCs are listed under this name. See all Dexmethylphenidate 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 Dexmethylphenidate hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride 5 mg/1	TabletOral	Bryant Ranch Prepack	72162-2426	72162-2426-0172162-2426-06
Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride 10 mg/1	TabletOral	Bryant Ranch Prepack	72162-2427	72162-2427-01
Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride 10 mg/1	TabletOral	Nivagen Pharmaceuticals, Inc.	75834-328	75834-0328-01
Dexmethylphenidate Hydrochloride	Dexmethylphenidate hydrochloride 5 mg/1	Capsule, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-229	31722-0229-01
Dexmethylphenidate Hydrochloride	Dexmethylphenidate hydrochloride 10 mg/1	Capsule, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-230	31722-0230-01
Dexmethylphenidate Hydrochloride	Dexmethylphenidate hydrochloride 15 mg/1	Capsule, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-231	31722-0231-01
Dexmethylphenidate Hydrochloride	Dexmethylphenidate hydrochloride 20 mg/1	Capsule, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-232	31722-0232-01
Dexmethylphenidate Hydrochloride	Dexmethylphenidate hydrochloride 25 mg/1	Capsule, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-233	31722-0233-01
Dexmethylphenidate Hydrochloride	Dexmethylphenidate hydrochloride 30 mg/1	Capsule, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-234	31722-0234-01
Dexmethylphenidate Hydrochloride	Dexmethylphenidate hydrochloride 35 mg/1	Capsule, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-235	31722-0235-01

All 73 Dexmethylphenidate hydrochloride NDCs

Other NDCs under ANDA 209211

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

FDA NDC Directory listings under ANDA 209211
Product	Strength	Form · route	Labeler	Product NDC
Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride 5 mg/1	TabletOral	Bryant Ranch Prepack	72162-2426
Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride 10 mg/1	TabletOral	Bryant Ranch Prepack	72162-2427
Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride 10 mg/1	TabletOral	Nivagen Pharmaceuticals, Inc.	75834-328