Prescription drug · ANDA
methylphenidate hydrochloride NDC 0591-3895
Methylphenidate hydrochloride 50 mg/1 · Capsule, Extended release · Oral · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0591-3895-19 | 00591389519 | 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.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208861
- Marketing start
- Listing expires
- 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
N400591389519followed by a unit qualifier and the quantityPackage 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 . 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.
Other NDCs under ANDA 208861
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 | Actavis Pharma, Inc. | 0591-3891 |
| methylphenidate hydrochloride | Methylphenidate hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Actavis Pharma, Inc. | 0591-3873 |
| methylphenidate hydrochloride | Methylphenidate hydrochloride 60 mg/1 | Capsule, Extended releaseOral | Actavis Pharma, Inc. | 0591-3902 |
| 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 |