Prescription drug · NDA
JORNAY PM Extended-Release (Methylphenidate hydrochloride) NDC 71376-203
Methylphenidate hydrochloride 60 mg/1 · Capsule · Oral · Ironshore Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71376-203-03 | 71376020303 | 100 CAPSULE in 1 BOTTLE (71376-203-03)Marketed from Jun 1, 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)
- JORNAY PM Extended-ReleaseSuffix: Extended-Release
- Generic name (nonproprietary)
- methylphenidate hydrochloride
- Active ingredients
- Methylphenidate hydrochloride — 60 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Ironshore Pharmaceuticals Inc.NDC labeler code 71376
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209311
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 71376-203_1c0e3d41-30b4-4815-8dbc-5466eaf56f8fSPL ID 1c0e3d41-30b4-4815-8dbc-5466eaf56f8fSPL set ID d95dede0-b1ff-4489-8f91-3bbe122852bfRxCUI 2168857, 2168859, 2168861, 2168863, 2168864, 2168865, 2168866, 2168867, 2168868, 2168869UNII 4B3SC438HIUPC 0371376202030, 0371376204034, 0371376205031, 0371376201033, 0371376203037
- 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
N471376020303followed by a unit qualifier and the quantityPackage 71376-0203-03. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
About NDC 71376-203
- What is NDC 71376-203?
- 71376-203 is the product NDC for JORNAY PM Extended-Release (methylphenidate hydrochloride), Methylphenidate hydrochloride 60 mg/1 capsule, listed with the FDA by Ironshore Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- JORNAY PM Extended-Release (Methylphenidate Hydrochloride).
- What is the active ingredient?
- Methylphenidate hydrochloride.
- Who is the labeler?
- Ironshore Pharmaceuticals Inc., NDC labeler code 71376. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for JORNAY PM Extended-Release?
- 4 other product NDCs are listed under this name. See all JORNAY PM 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 JORNAY PM 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) |
|---|---|---|---|---|---|
| JORNAY PM Extended-Releasemethylphenidate hydrochloride | Methylphenidate hydrochloride 20 mg/1 | CapsuleOral | Ironshore Pharmaceuticals Inc. | 71376-201 | 71376-0201-03 |
| JORNAY PM Extended-Releasemethylphenidate hydrochloride | Methylphenidate hydrochloride 40 mg/1 | CapsuleOral | Ironshore Pharmaceuticals Inc. | 71376-202 | 71376-0202-03 |
| JORNAY PM Extended-Releasemethylphenidate hydrochloride | Methylphenidate hydrochloride 80 mg/1 | CapsuleOral | Ironshore Pharmaceuticals Inc. | 71376-204 | 71376-0204-03 |
| JORNAY PM Extended-Releasemethylphenidate hydrochloride | Methylphenidate hydrochloride 100 mg/1 | CapsuleOral | Ironshore Pharmaceuticals Inc. | 71376-205 | 71376-0205-03 |
Other NDCs under NDA 209311
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 |
|---|---|---|---|---|
| JORNAY PM Extended-Releasemethylphenidate hydrochloride | Methylphenidate hydrochloride 20 mg/1 | CapsuleOral | Ironshore Pharmaceuticals Inc. | 71376-201 |
| JORNAY PM Extended-Releasemethylphenidate hydrochloride | Methylphenidate hydrochloride 40 mg/1 | CapsuleOral | Ironshore Pharmaceuticals Inc. | 71376-202 |
| JORNAY PM Extended-Releasemethylphenidate hydrochloride | Methylphenidate hydrochloride 80 mg/1 | CapsuleOral | Ironshore Pharmaceuticals Inc. | 71376-204 |
| JORNAY PM Extended-Releasemethylphenidate hydrochloride | Methylphenidate hydrochloride 100 mg/1 | CapsuleOral | Ironshore Pharmaceuticals Inc. | 71376-205 |