Prescription drug · ANDA
Perphenazine and Amitriptyline Hydrochloride NDC 0378-0330
Perphenazine 2 mg/1; Amitriptyline hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-0330-01 | 00378033001 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0330-01)Marketed from Nov 10, 1988 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Perphenazine and Amitriptyline Hydrochloride
- Generic name (nonproprietary)
- perphenazine and amitriptyline hydrochloride
- Active ingredients
- Perphenazine — 2 mg/1Amitriptyline hydrochloride — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 071443
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 0378-0330_a0ce12cc-6720-4bbe-9e86-41feb8e6d4cdSPL ID a0ce12cc-6720-4bbe-9e86-41feb8e6d4cdSPL set ID e2937445-c015-c9a5-52f8-a2959da97290RxCUI 856706, 856720, 856797, 856825, 856840UNII FTA7XXY4EZ, 26LUD4JO9K
- Pharmacologic class
- Phenothiazine; 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
N400378033001followed by a unit qualifier and the quantityPackage 00378-0330-01. 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 Perphenazine and amitriptyline hydrochloride tablets are recommended for treatment of (1) patients with moderate to severe anxiety and/or agitation and depressed mood, (2) patients with depression in whom anxiety and/or agitation are severe, and (3) patients with depression and anxiety in association with chronic physical disease. In many of these patients, anxiety masks the depressive state so that, although therapy with a tranquilizer appears to be indicated, the administration of a tranquilizer alone will not be adequate. Schizophrenic patients who have associated depressive symptoms should be considered for therapy with perphenazine and amitriptyline hydrochloride t…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 071443
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 |
|---|---|---|---|---|
| Perphenazine and Amitriptyline Hydrochloride | Perphenazine 2 mg/1; Amitriptyline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-0442 |
| Perphenazine and Amitriptyline Hydrochloride | Perphenazine 4 mg/1; Amitriptyline hydrochloride 10 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-0042 |
| Perphenazine and Amitriptyline Hydrochloride | Perphenazine 4 mg/1; Amitriptyline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-0574 |
| Perphenazine and Amitriptyline Hydrochloride | Perphenazine 4 mg/1; Amitriptyline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-0073 |