Prescription drug · ANDA
Protriptyline Hydrochloride NDC 42806-096
Protriptyline hydrochloride 5 mg/1 · Tablet, Film coated · Oral · Epic Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42806-096-01 | 42806009601 | 100 TABLET, FILM COATED in 1 BOTTLE (42806-096-01)Marketed from Jan 9, 2013 | |
| 42806-096-10 | 42806009610 | 1000 TABLET, FILM COATED in 1 BOTTLE (42806-096-10)Marketed from Jan 9, 2013 | |
| 42806-096-30 | 42806009630 | 30 TABLET, FILM COATED in 1 BOTTLE (42806-096-30)Marketed from Jul 10, 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
- Epic Pharma, LLCNDC labeler code 42806
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202220
- Marketing start
- Listing expires
- Identifiers
- Product ID 42806-096_e68d74c7-1d6a-4453-bb46-0047047b7527SPL ID e68d74c7-1d6a-4453-bb46-0047047b7527SPL set ID c6c7c39e-e510-4f4a-bf7a-926f0e075d3aRxCUI 905168, 905172UNII 44665V00O8UPC 0342806097014, 0342806096307
- 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
N442806009601followed by a unit qualifier and the quantityPackage 42806-0096-01. 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 . 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.
About NDC 42806-096
- What is NDC 42806-096?
- 42806-096 is the product NDC for Protriptyline Hydrochloride, Protriptyline hydrochloride 5 mg/1 tablet, film coated, listed with the FDA by Epic Pharma, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Protriptyline Hydrochloride.
- What is the active ingredient?
- Protriptyline hydrochloride.
- Who is the labeler?
- Epic Pharma, LLC, NDC labeler code 42806. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Protriptyline Hydrochloride?
- 3 other product NDCs are listed under this name. See all Protriptyline Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Protriptyline 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) |
|---|---|---|---|---|---|
| Protriptyline Hydrochloride | Protriptyline hydrochloride 5 mg/1 | Tablet, Film coatedOral | Sigmapharm Laboratories, LLC | 42794-004 | 42794-0004-02 |
| Protriptyline Hydrochloride | Protriptyline hydrochloride 10 mg/1 | Tablet, Film coatedOral | Sigmapharm Laboratories, LLC | 42794-007 | 42794-0007-02 |
| Protriptyline Hydrochloride | Protriptyline hydrochloride 10 mg/1 | Tablet, Film coatedOral | Epic Pharma, LLC | 42806-097 | 42806-0097-0142806-0097-1042806-0097-30 |
Other NDCs under ANDA 202220
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 | Epic Pharma, LLC | 42806-097 |