Methylphenidate Hydrochloride (LA) NDC 75907-050

NDC codes

FDA NDC Directory

Product NDC (as listed)75907-050Labeler and product segments. Claims need a package NDC.

Product NDC at billing width75907-0050Add 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
75907-050-01	75907005001	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (75907-050-01)Marketed from Dec 20, 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 (LA)
Generic name (nonproprietary): methylphenidate hydrochloride
Active ingredients: Methylphenidate hydrochloride — 20 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Dr. Reddy's Laboratories Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078458
Marketing start: Dec 20, 2024
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)
Identifiers: Product ID 75907-050_256aeb9c-b91a-46b9-35fc-94648f5f585cSPL ID 256aeb9c-b91a-46b9-35fc-94648f5f585cSPL set ID d8c14df4-ac05-d69d-9308-58a51d568329RxCUI 1806177, 1806179, 1806183, 1806185, 1806195UNII 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

N475907005001 followed by a unit qualifier and the quantity

Package 75907-0050-01. 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 Sep 30, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Methylphenidate hydrochloride extended-release capsules (LA) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies (14) ] . Limitation of Use The use of Methylphenidate hydrochloride extended-release capsules (LA) 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 (LA) is a central nervous system (CNS…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078458

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

FDA NDC Directory listings under ANDA 078458
Product	Strength	Form · route	Labeler	Product NDC
Methylphenidate Hydrochloride (LA)methylphenidate hydrochloride	Methylphenidate hydrochloride 30 mg/1	Capsule, Extended releaseOral	Dr. Reddy's Laboratories Inc	75907-051
Methylphenidate Hydrochloride (LA)methylphenidate hydrochloride	Methylphenidate hydrochloride 40 mg/1	Capsule, Extended releaseOral	Dr. Reddy's Laboratories Inc	75907-052
Methylphenidate Hydrochloride (LA)methylphenidate hydrochloride	Methylphenidate hydrochloride 60 mg/1	Capsule, Extended releaseOral	Dr. Reddy's Laboratories Inc	75907-053