Prescription drug · ANDA
Tranylcypromine NDC 70518-4708
Tranylcypromine sulfate 10 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4708-0 | 7051847080070518470800 | 100 POUCH in 1 BOX (70518-4708-0) / 1 TABLET in 1 POUCH (70518-4708-1)Marketed from Jul 21, 2026 |
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)
- Tranylcypromine
- Generic name (nonproprietary)
- tranylcypromine
- Active ingredients
- Tranylcypromine sulfate — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213503
- Marketing start
- Listing expires
- Other FDA classes
- Monoamine Oxidase Inhibitors (Mechanism)
- Identifiers
- Product ID 70518-4708_57321a72-7260-30d4-e063-6394a90a3fb3SPL ID 57321a72-7260-30d4-e063-6394a90a3fb3SPL set ID 83942f11-e10c-4c2d-ad78-880e1886064dRxCUI 313447UNII 7ZAT6ES870
- Pharmacologic class
- Monoamine Oxidase 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
N470518470800followed by a unit qualifier and the quantityPackage 70518-4708-00. 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)
Tranylcypromine tablets are indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants. Tranylcypromine tablets are not indicated for the initial treatment of MDD due to the potential for serious adverse reactions and drug interactions, and the need for dietary restrictions [see Contraindications (4) , Warnings and Precautions (5) , and Drug Interactions (7) ] . Tranylcypromine tablets are a monoamine oxidase inhibitor (MAOI) indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants ( 1 ) Tranylcypromine tablets are not indicated f…
Excerpt only. Read the full label for complete information.
About NDC 70518-4708
- What is NDC 70518-4708?
- 70518-4708 is the product NDC for Tranylcypromine, Tranylcypromine sulfate 10 mg/1 tablet, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tranylcypromine.
- What is the active ingredient?
- Tranylcypromine sulfate.
- Who is the labeler?
- REMEDYREPACK INC., NDC labeler code 70518. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tranylcypromine?
- 2 other product NDCs are listed under this name. See all Tranylcypromine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tranylcypromine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tranylcypromine | Tranylcypromine sulfate 10 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-655 | 43547-0655-10 |
| Tranylcypromine | Tranylcypromine sulfate 10 mg/1 | TabletOral | Novitium Pharma LLC | 70954-538 | 70954-0538-10 |
Other NDCs under ANDA 213503
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 |
|---|---|---|---|---|
| Tranylcypromine | Tranylcypromine sulfate 10 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-655 |