What is NDC 0591-3895?

0591-3895 is the product NDC for methylphenidate hydrochloride, Methylphenidate hydrochloride 50 mg/1 capsule, extended release, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Actavis Pharma, Inc., NDC labeler code 0591. 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 0591-3895

NDC codes

FDA NDC Directory

Product NDC (as listed)0591-3895Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00591-3895Add 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
0591-3895-19	0059138951900591389519	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0591-3895-19)Marketed from Sep 30, 2020

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 50 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Actavis Pharma, Inc.NDC labeler code 0591
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208861
Marketing start: Sep 30, 2020
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)
Identifiers: Product ID 0591-3895_1895894a-ed70-4f82-b512-6bc184ee806cSPL ID 1895894a-ed70-4f82-b512-6bc184ee806cSPL set ID ecbb4a30-21ac-42e1-b4e9-6c35344ffc45RxCUI 1648183, 1806200, 1806202, 1806204, 1806206, 1806208, 1806210UNII 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

N400591389519 followed by a unit qualifier and the quantity

Package 00591-3895-19. 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 Oct 31, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies ( 14 )] . Limitations of Use The use of methylphenidate hydrochloride extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions ( 5.7 ), Use in Specific Populations ( 8.4 )] . Methylphenidate hydrochloride extended-release capsules are a central nervous system (CNS) stimulant indicated …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0591-3895

What is NDC 0591-3895?: 0591-3895 is the product NDC for methylphenidate hydrochloride, Methylphenidate hydrochloride 50 mg/1 capsule, extended release, listed with the FDA by Actavis Pharma, 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?: Actavis Pharma, Inc., NDC labeler code 0591. 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 208861

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

FDA NDC Directory listings under ANDA 208861
Product	Strength	Form · route	Labeler	Product NDC
methylphenidate hydrochloride	Methylphenidate hydrochloride 10 mg/1	Capsule, Extended releaseOral	Actavis Pharma, Inc.	0591-3854
methylphenidate hydrochloride	Methylphenidate hydrochloride 15 mg/1	Capsule, Extended releaseOral	Actavis Pharma, Inc.	0591-3862
methylphenidate hydrochloride	Methylphenidate hydrochloride 20 mg/1	Capsule, Extended releaseOral	Actavis Pharma, Inc.	0591-3869
methylphenidate hydrochloride	Methylphenidate hydrochloride 30 mg/1	Capsule, Extended releaseOral	Actavis Pharma, Inc.	0591-3873
methylphenidate hydrochloride	Methylphenidate hydrochloride 40 mg/1	Capsule, Extended releaseOral	Actavis Pharma, Inc.	0591-3891
methylphenidate hydrochloride	Methylphenidate hydrochloride 60 mg/1	Capsule, Extended releaseOral	Actavis Pharma, Inc.	0591-3902