What is NDC 75834-326?

75834-326 is the product NDC for Methylphenidate Hydrochloride, Methylphenidate hydrochloride 20 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 Methylphenidate Hydrochloride?

148 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Methylphenidate Hydrochloride NDC 75834-326

NDC codes

FDA NDC Directory

Product NDC (as listed)75834-326Labeler and product segments. Claims need a package NDC.

Product NDC at billing width75834-0326Add 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
75834-326-01	7583403260175834032601	100 TABLET in 1 BOTTLE (75834-326-01)Marketed from Apr 16, 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): Methylphenidate Hydrochloride
Generic name (nonproprietary): methylphenidate hydrochloride
Active ingredients: Methylphenidate hydrochloride — 20 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 208737
Marketing start: Apr 16, 2024
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)
Identifiers: Product ID 75834-326_4cc16009-44ad-4055-ac76-efa282f1ff47SPL ID 4cc16009-44ad-4055-ac76-efa282f1ff47SPL set ID 4cc16009-44ad-4055-ac76-efa282f1ff47RxCUI 1091150, 1091392, 1091497UNII 4B3SC438HI
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

N475834032601 followed by a unit qualifier and the quantity

Package 75834-0326-01. 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 Feb 26, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Methylphenidate hydrochloride tablets are indicated for the treatment of: • Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults • Narcolepsy Methylphenidate hydrochloride tablets are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 75834-326

What is NDC 75834-326?: 75834-326 is the product NDC for Methylphenidate Hydrochloride, Methylphenidate hydrochloride 20 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?: Methylphenidate Hydrochloride.
What is the active ingredient?: Methylphenidate 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 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 72 mg/1	Tablet, Extended releaseOral	Northstar Rx LLC	72603-399	72603-0399-01
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 72 mg/1	Tablet, Extended releaseOral	Sun Pharmaceutical Industries, Inc.	57664-710	57664-0710-8357664-0710-88
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 10 mg/1	TabletOral	Bryant Ranch Prepack	71335-2968	71335-2968-01
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 5 mg/1	TabletOral	Nivagen Pharmaceuticals, Inc.	75834-324	75834-0324-01
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 10 mg/1	TabletOral	Nivagen Pharmaceuticals, Inc.	75834-325	75834-0325-01
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 5 mg/1	TabletOral	Bryant Ranch Prepack	72162-2428	72162-2428-01
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 10 mg/1	TabletOral	Bryant Ranch Prepack	72162-2429	72162-2429-01
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 20 mg/1	TabletOral	Bryant Ranch Prepack	72162-2430	72162-2430-01
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 63 mg/1	Tablet, Extended releaseOral	Trigen Laboratories, LLC	13811-700	13811-0700-30
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 45 mg/1	Tablet, Extended releaseOral	Trigen Laboratories, LLC	13811-711	13811-0711-30

All 149 Methylphenidate Hydrochloride NDCs

Other NDCs under ANDA 208737

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

FDA NDC Directory listings under ANDA 208737
Product	Strength	Form · route	Labeler	Product NDC
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 10 mg/1	TabletOral	Bryant Ranch Prepack	71335-2968
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 5 mg/1	TabletOral	Bryant Ranch Prepack	72162-2428
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 10 mg/1	TabletOral	Bryant Ranch Prepack	72162-2429
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 20 mg/1	TabletOral	Bryant Ranch Prepack	72162-2430
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 5 mg/1	TabletOral	Nivagen Pharmaceuticals, Inc.	75834-324
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 10 mg/1	TabletOral	Nivagen Pharmaceuticals, Inc.	75834-325