What is NDC 31722-954?

31722-954 is the product NDC for Methylphenidate Hydrochloride, Methylphenidate hydrochloride 36 mg/1 tablet, extended release, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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 31722-954

NDC codes

FDA NDC Directory

Product NDC (as listed)31722-954Labeler and product segments. Claims need a package NDC.

Product NDC at billing width31722-0954Add 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
31722-954-01	3172209540131722095401	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-954-01)Marketed from Sep 3, 2019

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 — 36 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Camber Pharmaceuticals, Inc.NDC labeler code 31722
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211009
Marketing start: Sep 3, 2019
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)
Identifiers: Product ID 31722-954_1d1d77b9-0f73-4daf-8ca6-0837caa03bacSPL ID 1d1d77b9-0f73-4daf-8ca6-0837caa03bacSPL set ID b9af3104-172d-4975-9301-b9fe7db9ef12RxCUI 1091155, 1091170, 1091185, 1091210UNII 4B3SC438HIUPC 0331722955010, 0331722954013, 0331722952019, 0331722953016
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

N431722095401 followed by a unit qualifier and the quantity

Package 31722-0954-01. 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 Aug 17, 2021. 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 31722-954

What is NDC 31722-954?: 31722-954 is the product NDC for Methylphenidate Hydrochloride, Methylphenidate hydrochloride 36 mg/1 tablet, extended release, listed with the FDA by Camber 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?: Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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 20 mg/1	TabletOral	Nivagen Pharmaceuticals, Inc.	75834-326	75834-0326-01
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

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
Product	Strength	Form · route	Labeler	Product NDC
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 18 mg/1	Tablet, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-952
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 27 mg/1	Tablet, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-953
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 54 mg/1	Tablet, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-955
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 18 mg/1	Tablet, Extended releaseOral	American Health Packaging	60687-532
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 27 mg/1	Tablet, Extended releaseOral	American Health Packaging	60687-543
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 36 mg/1	Tablet, Extended releaseOral	American Health Packaging	60687-554
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 54 mg/1	Tablet, Extended releaseOral	American Health Packaging	60687-565
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 18 mg/1	Tablet, Extended releaseOral	XLCare Pharmaceuticals, Inc.	72865-133
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 27 mg/1	Tablet, Extended releaseOral	XLCare Pharmaceuticals, Inc.	72865-134
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 36 mg/1	Tablet, Extended releaseOral	XLCare Pharmaceuticals, Inc.	72865-135
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 54 mg/1	Tablet, Extended releaseOral	XLCare Pharmaceuticals, Inc.	72865-136