Prescription drug · ANDA
Selegiline Hydrochloride NDC 71335-2676
Selegiline hydrochloride 5 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2676-1 | 71335267601 | 30 CAPSULE in 1 BOTTLE (71335-2676-1)Marketed from Aug 18, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Bryant Ranch Prepack
- 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 71335-2676_c3d9a9b2-d6f7-4008-9fa8-e198f1f5bbbbSPL ID c3d9a9b2-d6f7-4008-9fa8-e198f1f5bbbbSPL set ID b8eb0a00-adc7-4aaf-987c-fa1b207b2996RxCUI 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
N471335267601followed by a unit qualifier and the quantityPackage 71335-2676-01. 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 .
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.
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 | Marlex Pharmaceuticals, Inc. | 10135-737 |
| Selegiline Hydrochloride | Selegiline hydrochloride 5 mg/1 | CapsuleOral | Novitium Pharma LLC | 70954-504 |