Prescription drug · ANDA
Amitriptyline Hydrochloride NDC 68071-4104
Amitriptyline hydrochloride 10 mg/1 · Tablet, Film coated · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-4104-1 | 68071410401 | 100 TABLET, FILM COATED in 1 BOTTLE (68071-4104-1)Marketed from Sep 29, 2017 |
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)
- Amitriptyline Hydrochloride
- Generic name (nonproprietary)
- amitriptyline hydrochloride
- Active ingredients
- Amitriptyline hydrochloride — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202446
- Marketing start
- Listing expires
- Identifiers
- Product ID 68071-4104_1d8e3ff7-d1f4-0a8a-e063-6294a90ac4aeSPL ID 1d8e3ff7-d1f4-0a8a-e063-6294a90ac4aeSPL set ID 5a5a4040-5395-54ac-e053-2991aa0aa4abRxCUI 856783UNII 26LUD4JO9KUPC 0368071410419
- 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
N468071410401followed by a unit qualifier and the quantityPackage 68071-4104-01. 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 For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202446
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 |
|---|---|---|---|---|
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0395 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 10 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-637 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 10 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-632 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 150 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0566 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3564 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 10 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4092 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 10 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-171 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-175 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 150 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-176 |
| Amitriptyline HCL | Amitriptyline hydrochloride 10 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0172 |