Prescription drug · ANDA
Selegiline Hydrochloride NDC 62135-694
Selegiline hydrochloride 5 mg/1 · Tablet · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-694-60 | 6213506946062135069460 | 60 TABLET in 1 BOTTLE (62135-694-60)Marketed from May 6, 2024 |
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)
- Selegiline Hydrochloride
- Generic name (nonproprietary)
- selegiline hydrochloride
- Active ingredients
- Selegiline hydrochloride — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Chartwell RX, LLCNDC labeler code 62135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074565
- Marketing start
- Listing expires
- Other FDA classes
- Monoamine Oxidase Inhibitors (Mechanism)Monoamine Oxidase-B Inhibitors (Mechanism)
- Identifiers
- Product ID 62135-694_17f2fc17-a150-214b-e063-6294a90ab548SPL ID 17f2fc17-a150-214b-e063-6294a90ab548SPL set ID 189ac32d-28b4-47c5-9de6-318e502eff3bRxCUI 859193UNII 6W731X367QUPC 0362135694609
- Pharmacologic class
- Monoamine Oxidase Inhibitor; Monoamine Oxidase Type B Inhibitor
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
N462135069460followed by a unit qualifier and the quantityPackage 62135-0694-60. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Selegiline Hydrochloride Tablets are indicated as an adjunct in the management of Parkinsonian patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. There is no evidence from controlled studies that selegiline has any beneficial effect in the absence of concurrent levodopa therapy. Evidence supporting this claim was obtained in randomized controlled clinical investigations that compared the effects of added selegiline or placebo in patients receiving levodopa/carbidopa. Selegiline was significantly superior to placebo on all three principal outcome measures employed: change from baseline in daily levod…
Excerpt only. Read the full label for complete information.
About NDC 62135-694
- What is NDC 62135-694?
- 62135-694 is the product NDC for Selegiline Hydrochloride, Selegiline hydrochloride 5 mg/1 tablet, listed with the FDA by Chartwell RX, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Selegiline Hydrochloride.
- What is the active ingredient?
- Selegiline hydrochloride.
- Who is the labeler?
- Chartwell RX, LLC, NDC labeler code 62135. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Selegiline Hydrochloride?
- 12 other product NDCs are listed under this name. See all Selegiline Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Selegiline Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Selegiline Hydrochloride | Selegiline hydrochloride 5 mg/1 | TabletOral | A2A Integrated Pharmaceuticals | 73141-006 | 73141-0006-02 |
| Selegiline Hydrochloride | Selegiline hydrochloride 5 mg/1 | TabletOral | i3 Pharmaceuticals, LLC | 72319-006 | 72319-0006-02 |
| Selegiline Hydrochloride | Selegiline hydrochloride 5 mg/1 | CapsuleOral | Marlex Pharmaceuticals, Inc. | 10135-737 | 10135-0737-60 |
| Selegiline Hydrochloride | Selegiline hydrochloride 5 mg/1 | CapsuleOral | Novitium Pharma LLC | 70954-504 | 70954-0504-1070954-0504-20 |
| Selegiline Hydrochloride | Selegiline hydrochloride 5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2676 | 71335-2676-01 |
| Selegiline Hydrochloride | Selegiline hydrochloride 5 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 16571-659 | 16571-0659-0616571-0659-50 |
| Selegiline Hydrochloride | Selegiline hydrochloride 5 mg/1 | CapsuleOral | Proficient Rx LP | 71205-888 | 71205-0888-0071205-0888-1171205-0888-30+3 more |
| Selegiline Hydrochloride | Selegiline hydrochloride 5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2673 | 71335-2673-01 |
| Selegiline Hydrochloride | Selegiline hydrochloride 5 mg/1 | CapsuleOral | Apotex Corp. | 60505-0055 | 60505-0055-0160505-0055-0260505-0055-03 |
| Selegiline Hydrochloride | Selegiline hydrochloride 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-2918 | 50090-2918-00 |