Prescription drug · ANDA
Protriptyline Hydrochloride NDC 42794-004
Protriptyline hydrochloride 5 mg/1 · Tablet, Film coated · Oral · Sigmapharm Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42794-004-02 | 42794000402 | 100 TABLET, FILM COATED in 1 BOTTLE (42794-004-02)Marketed from Mar 2, 2020 |
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)
- Protriptyline Hydrochloride
- Generic name (nonproprietary)
- protriptyline hydrochloride
- Active ingredients
- Protriptyline hydrochloride — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Sigmapharm Laboratories, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090462
- Marketing start
- Listing expires
- Identifiers
- Product ID 42794-004_f1f190da-554e-55cb-e053-2a95a90a2871SPL ID f1f190da-554e-55cb-e053-2a95a90a2871SPL set ID a023e637-bee9-8c86-e053-2a95a90aa488RxCUI 905168, 905172UNII 44665V00O8UPC 0342794007026, 0342794004025
- Pharmacologic class
- Tricyclic Antidepressant
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
N442794000402followed by a unit qualifier and the quantityPackage 42794-0004-02. 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)
INDICATIONS AND USAGE Protriptyline hydrochloride tablets are indicated for the treatment of symptoms of mental depression in patients who are under close medical supervision. Its activating properties make it particularly suitable for withdrawn and anergic patients.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090462
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 |
|---|---|---|---|---|
| Protriptyline Hydrochloride | Protriptyline hydrochloride 10 mg/1 | Tablet, Film coatedOral | Sigmapharm Laboratories, LLC | 42794-007 |