What is NDC 63629-1176?

63629-1176 is the product NDC for Methylphenidate Hydrochloride, Methylphenidate hydrochloride 10 mg/5mL solution, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 63629. 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?

149 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 63629-1176

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-1176Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-1176Add 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
63629-1176-1	63629117601	500 mL in 1 BOTTLE (63629-1176-1)Marketed from Jun 29, 2021

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 10 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Bryant Ranch PrepackNDC labeler code 63629
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210139
Marketing start: Mar 29, 2019
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)
Identifiers: Product ID 63629-1176_766addd2-4d8e-4ce0-b09b-746632c16ac6SPL ID 766addd2-4d8e-4ce0-b09b-746632c16ac6SPL set ID b49863bd-20ba-44d5-8dab-96fcbd276a5cRxCUI 1091133UNII 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

N463629117601 followed by a unit qualifier and the quantity

Package 63629-1176-01. 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 10, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Attention Deficit Disorders, Narcolepsy Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction. Methylphenidate hydrochloride oral solution is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-1176

What is NDC 63629-1176?: 63629-1176 is the product NDC for Methylphenidate Hydrochloride, Methylphenidate hydrochloride 10 mg/5mL solution, listed with the FDA by Bryant Ranch Prepack. 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?: Bryant Ranch Prepack, NDC labeler code 63629. 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?: 149 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 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 20 mg/1	TabletOral	Nivagen Pharmaceuticals, Inc.	75834-326	75834-0326-01
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 10 mg/1	TabletOral	Bryant Ranch Prepack	71335-2968	71335-2968-01
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 63 mg/1	Tablet, Extended releaseOral	Trigen Laboratories, LLC	13811-700	13811-0700-30

All 150 Methylphenidate Hydrochloride NDCs

Other NDCs under ANDA 210139

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

FDA NDC Directory listings under ANDA 210139
Product	Strength	Form · route	Labeler	Product NDC
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 5 mg/5mL	SolutionOral	Eywa Pharma Inc	71930-024
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 10 mg/5mL	SolutionOral	Eywa Pharma Inc	71930-025
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 5 mg/5mL	SolutionOral	Bryant Ranch Prepack	63629-1175
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 10 mg/5mL	SolutionOral	Bryant Ranch Prepack	72162-1993
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 5 mg/5mL	SolutionOral	Bryant Ranch Prepack	72162-1992