What is NDC 31722-235?

31722-235 is the product NDC for Dexmethylphenidate Hydrochloride, Dexmethylphenidate hydrochloride 35 mg/1 capsule, 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 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 31722-235

NDC codes

FDA NDC Directory

Product NDC (as listed)31722-235Labeler and product segments. Claims need a package NDC.

Product NDC at billing width31722-0235Add 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
31722-235-01	31722023501	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-235-01)Marketed from Dec 8, 2021

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 — 35 mg/1
Dosage form: Capsule, 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 215523
Marketing start: Dec 8, 2021
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)
Identifiers: Product ID 31722-235_81c8ba81-82ac-4c18-b28b-da9c71520f35SPL ID 81c8ba81-82ac-4c18-b28b-da9c71520f35SPL set ID 77659abe-74be-4092-90fe-cc475726d4ecRxCUI 899439, 899461, 899485, 899495, 899511, 1006608, 1101926, 1101932UNII 1678OK0E08UPC 0331722233019, 0331722229012, 0331722234016, 0331722235013, 0331722231015, 0331722236010, 0331722232012, 0331722230018
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

N431722023501 followed by a unit qualifier and the quantity

Package 31722-0235-01. 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 Dec 17, 2021. This label includes a boxed warning.

Indications (excerpt from the label)

Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)] . Dexmethylphenidate hydrochloride extended-release capsules are 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)

About NDC 31722-235

What is NDC 31722-235?: 31722-235 is the product NDC for Dexmethylphenidate Hydrochloride, Dexmethylphenidate hydrochloride 35 mg/1 capsule, 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?: Dexmethylphenidate Hydrochloride.
What is the active ingredient?: Dexmethylphenidate 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 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	TabletOral	Nivagen Pharmaceuticals, Inc.	75834-327	75834-0327-01
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 30 mg/1	Capsule, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-234	31722-0234-01
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

All 73 Dexmethylphenidate Hydrochloride NDCs

Other NDCs under ANDA 215523

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

FDA NDC Directory listings under ANDA 215523
Product	Strength	Form · route	Labeler	Product NDC
Dexmethylphenidate Hydrochloride	Dexmethylphenidate hydrochloride 5 mg/1	Capsule, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-229
Dexmethylphenidate Hydrochloride	Dexmethylphenidate hydrochloride 10 mg/1	Capsule, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-230
Dexmethylphenidate Hydrochloride	Dexmethylphenidate hydrochloride 30 mg/1	Capsule, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-234
Dexmethylphenidate Hydrochloride	Dexmethylphenidate hydrochloride 15 mg/1	Capsule, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-231
Dexmethylphenidate Hydrochloride	Dexmethylphenidate hydrochloride 20 mg/1	Capsule, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-232
Dexmethylphenidate Hydrochloride	Dexmethylphenidate hydrochloride 25 mg/1	Capsule, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-233
Dexmethylphenidate Hydrochloride	Dexmethylphenidate hydrochloride 40 mg/1	Capsule, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-236