Prescription drug · ANDA
Methylphenidate Hydrochloride Extended Release NDC 10702-076
Methylphenidate hydrochloride 20 mg/1 · Tablet · Oral · KVK-Tech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10702-076-01 | 1070200760110702007601 | 100 TABLET in 1 BOTTLE (10702-076-01)Marketed from Jun 9, 2015 | |
| 10702-076-06 | 1070200760610702007606 | 60 TABLET in 1 BOTTLE (10702-076-06)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 hydrochloride — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- KVK-Tech, Inc.NDC labeler code 10702
- 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 10702-076_40950048-0e42-4661-e063-6394a90a2bb1SPL ID 40950048-0e42-4661-e063-6394a90a2bb1SPL set ID be8580bc-0eb2-4eb6-a4cc-4ebbeb33424dRxCUI 1091145, 1091225UNII 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
N410702007601followed by a unit qualifier and the quantityPackage 10702-0076-01. 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.
About NDC 10702-076
- What is NDC 10702-076?
- 10702-076 is the product NDC for Methylphenidate Hydrochloride Extended Release, Methylphenidate hydrochloride 20 mg/1 tablet, listed with the FDA by KVK-Tech, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Methylphenidate Hydrochloride Extended Release.
- What is the active ingredient?
- Methylphenidate hydrochloride.
- Who is the labeler?
- KVK-Tech, Inc., NDC labeler code 10702. 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 Extended Release?
- 10 other product NDCs are listed under this name. See all Methylphenidate Hydrochloride Extended Release NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Methylphenidate Hydrochloride Extended Release products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Methylphenidate Hydrochloride Extended-Releasemethylphenidate hydrochloride | Methylphenidate hydrochloride 10 mg/1 | Capsule, Extended releaseOral | SpecGx LLC | 0406-1810 | 00406-1810-01 |
| Methylphenidate Hydrochloride Extended-Releasemethylphenidate hydrochloride | Methylphenidate hydrochloride 20 mg/1 | Capsule, Extended releaseOral | SpecGx LLC | 0406-1820 | 00406-1820-01 |
| Methylphenidate Hydrochloride Extended-Releasemethylphenidate hydrochloride | Methylphenidate hydrochloride 30 mg/1 | Capsule, Extended releaseOral | SpecGx LLC | 0406-1830 | 00406-1830-01 |
| Methylphenidate Hydrochloride Extended-Releasemethylphenidate hydrochloride | Methylphenidate hydrochloride 40 mg/1 | Capsule, Extended releaseOral | SpecGx LLC | 0406-1840 | 00406-1840-01 |
| Methylphenidate Hydrochloride Extended-Releasemethylphenidate hydrochloride | Methylphenidate hydrochloride 50 mg/1 | Capsule, Extended releaseOral | SpecGx LLC | 0406-1850 | 00406-1850-01 |
| Methylphenidate Hydrochloride Extended-Releasemethylphenidate hydrochloride | Methylphenidate hydrochloride 60 mg/1 | Capsule, Extended releaseOral | SpecGx LLC | 0406-1860 | 00406-1860-01 |
| Methylphenidate Hydrochloride Extended Release | Methylphenidate hydrochloride 10 mg/1 | TabletOral | KVK-Tech, Inc. | 10702-075 | 10702-0075-0110702-0075-06 |
| Methylphenidate Hydrochloride Extended-Releasemethylphenidate hydrochloride | Methylphenidate hydrochloride 27 mg/1 | Tablet, Extended releaseOral | SpecGx LLC | 0406-0127 | 00406-0127-01 |
| Methylphenidate Hydrochloride Extended-Releasemethylphenidate hydrochloride | Methylphenidate hydrochloride 36 mg/1 | Tablet, Extended releaseOral | SpecGx LLC | 0406-0136 | 00406-0136-01 |
| Methylphenidate Hydrochloride Extended-Releasemethylphenidate hydrochloride | Methylphenidate hydrochloride 54 mg/1 | Tablet, Extended releaseOral | SpecGx LLC | 0406-0154 | 00406-0154-01 |
Other NDCs under ANDA 207488
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Methylphenidate Hydrochloride Extended Release | Methylphenidate hydrochloride 10 mg/1 | TabletOral | KVK-Tech, Inc. | 10702-075 |