Prescription drug · ANDA
Selegiline Hydrochloride NDC 10135-737
Selegiline hydrochloride 5 mg/1 · Capsule · Oral · Marlex Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10135-737-60 | 10135073760 | 60 CAPSULE in 1 BOTTLE (10135-737-60)Marketed from May 1, 2021 |
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
- Capsule
- Route
- Oral
- Labeler
- Marlex Pharmaceuticals, Inc.NDC labeler code 10135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075352
- Marketing start
- Listing expires
- Other FDA classes
- Monoamine Oxidase Inhibitors (Mechanism)Monoamine Oxidase-B Inhibitors (Mechanism)
- Identifiers
- Product ID 10135-737_441eef3c-3c0d-08b3-e063-6394a90afef9SPL ID 441eef3c-3c0d-08b3-e063-6394a90afef9SPL set ID df88d6bf-0fda-3825-e053-2a95a90a3a75RxCUI 859186UNII 6W731X367Q
- 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
N410135073760followed by a unit qualifier and the quantityPackage 10135-0737-60. 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 & USAGE Selegiline hydrochloride capsules, USP 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 l…
Excerpt only. Read the full label for complete information.
About NDC 10135-737
- What is NDC 10135-737?
- 10135-737 is the product NDC for Selegiline Hydrochloride, Selegiline hydrochloride 5 mg/1 capsule, listed with the FDA by Marlex Pharmaceuticals, Inc.. 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?
- Marlex Pharmaceuticals, Inc., NDC labeler code 10135. 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 | 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 |
| Selegiline Hydrochloride | Selegiline hydrochloride 5 mg/1 | TabletOral | Apotex Corp. | 60505-3438 | 60505-3438-0360505-3438-08 |
Other NDCs under ANDA 075352
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 |
|---|---|---|---|---|
| Selegiline Hydrochloride | Selegiline hydrochloride 5 mg/1 | CapsuleOral | Novitium Pharma LLC | 70954-504 |
| Selegiline Hydrochloride | Selegiline hydrochloride 5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2676 |