Prescription drug · ANDA
Methylphenidate Hydrochloride NDC 70010-012
Methylphenidate hydrochloride 10 mg/1 · Capsule, Extended release · Oral · Granules Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70010-012-01 | 70010001201 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-012-01)Marketed from Sep 10, 2019 |
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
- Generic name (nonproprietary)
- methylphenidate hydrochloride
- Active ingredients
- Methylphenidate hydrochloride — 10 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211796
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 70010-012_40a67d01-89e6-a878-e063-6394a90ae051SPL ID 40a67d01-89e6-a878-e063-6394a90ae051SPL set ID 27ea91ad-f64e-43d7-ab10-6f988bca5379RxCUI 1806177, 1806179, 1806183, 1806185, 1806195UNII 4B3SC438HIUPC 0370010014015, 0370010012011, 0370010013018, 0370010015012, 0370010016033
- 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
N470010001201followed by a unit qualifier and the quantityPackage 70010-0012-01. 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 capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [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 capsule is a central nervous system (CNS) stimulant i…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211796
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 | Methylphenidate hydrochloride 40 mg/1 | Capsule, Extended releaseOral | Granules Pharmaceuticals Inc. | 70010-015 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 20 mg/1 | Capsule, Extended releaseOral | Granules Pharmaceuticals Inc. | 70010-013 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Granules Pharmaceuticals Inc. | 70010-014 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 60 mg/1 | Capsule, Extended releaseOral | Granules Pharmaceuticals Inc. | 70010-016 |