NDC codes

FDA NDC Directory
Product NDC (as listed)10702-075Labeler and product segments. Claims need a package NDC.
Product NDC at billing width10702-0075Add 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 NDC11-digit (billing)PackageCopy
10702-075-0110702007501100 TABLET in 1 BOTTLE (10702-075-01)Marketed from Jun 9, 2015
10702-075-061070200750660 TABLET in 1 BOTTLE (10702-075-06)Marketed from Jun 9, 2015

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 Extended Release
Generic name (nonproprietary)
methylphenidate hydrochloride extended release
Active ingredients
Methylphenidate hydrochloride10 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207488
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Central Nervous System Stimulation (Physiologic effect)
Identifiers
Product ID 10702-075_40950048-0e42-4661-e063-6394a90a2bb1SPL ID 40950048-0e42-4661-e063-6394a90a2bb1SPL set ID be8580bc-0eb2-4eb6-a4cc-4ebbeb33424dRxCUI 1091145, 1091225UNII 4B3SC438HI

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

N410702007501 followed by a unit qualifier and the quantity

Package 10702-0075-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of: • Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults • Narcolepsy Limitations of Use: The use of Methylphenidate hydrochloride 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 tablet is a central nervous system (CNS) stimulant indicated for the treatment of Attenti

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207488

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

FDA NDC Directory listings under ANDA 207488
ProductStrengthForm · routeLabelerProduct NDC
Methylphenidate Hydrochloride Extended ReleaseMethylphenidate hydrochloride 20 mg/1TabletOralKVK-Tech, Inc.10702-076

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