Prescription drug · ANDA
Amitriptyline HCL NDC 80425-0172
Amitriptyline hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0172-1 | 8042501720180425017201 | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0172-1)Marketed from Dec 5, 2014 | |
| 80425-0172-2 | 8042501720280425017202 | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0172-2)Marketed from Dec 5, 2014 |
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 HCL
- Generic name (nonproprietary)
- amitriptyline hcl
- Active ingredients
- Amitriptyline hydrochloride — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202446
- Marketing start
- Listing expires
- Identifiers
- Product ID 80425-0172_2a99a670-af32-299d-e063-6294a90a05d2SPL ID 2a99a670-af32-299d-e063-6294a90a05d2SPL set ID ca66c2fc-6724-f4cd-e053-2995a90a42cfRxCUI 856783UNII 26LUD4JO9K
- 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
N480425017201followed by a unit qualifier and the quantityPackage 80425-0172-01. 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)
3. 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.
About NDC 80425-0172
- What is NDC 80425-0172?
- 80425-0172 is the product NDC for Amitriptyline HCL, Amitriptyline hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Amitriptyline HCL.
- What is the active ingredient?
- Amitriptyline hydrochloride.
- Who is the labeler?
- Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Amitriptyline HCL?
- 7 other product NDCs are listed under this name. See all Amitriptyline HCL NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Amitriptyline HCL products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Amitriptyline HCL | Amitriptyline hydrochloride 150 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-622 | 72189-0622-30 |
| Amitriptyline HCL | Amitriptyline hydrochloride 150 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-588 | 72189-0588-30 |
| Amitriptyline HCL | Amitriptyline hydrochloride 100 mg/1 | TabletOral | Direct_rx | 72189-581 | 72189-0581-30 |
| Amitriptyline HCL | Amitriptyline hydrochloride 75 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-444 | 72189-0444-30 |
| Amitriptyline HCL | Amitriptyline hydrochloride 10 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-431 | 72189-0431-3072189-0431-6072189-0431-90 |
| Amitriptyline HCL | Amitriptyline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-440 | 72189-0440-3072189-0440-6072189-0440-90 |
| Amitriptyline HCl | Amitriptyline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-420 | 72189-0420-3072189-0420-6072189-0420-90 |
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 | 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 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 | Northwind Health Company, LLC | 51655-632 |
| 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 | NuCare Pharmaceuticals,Inc. | 68071-4092 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 10 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4104 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0395 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 150 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0566 |