Prescription drug · ANDA
Amitriptyline HCL NDC 72189-444
Amitriptyline hydrochloride 75 mg/1 · Tablet, Film coated · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-444-30 | 72189044430 | 30 TABLET, FILM COATED in 1 BOTTLE (72189-444-30)Marketed from Mar 14, 2023 |
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)
- Amitriptyline HCL
- Generic name (nonproprietary)
- amitriptyline hcl
- Active ingredients
- Amitriptyline hydrochloride — 75 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Direct_Rx
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214548
- Marketing start
- Listing expires
- Identifiers
- Product ID 72189-444_2c4d9d53-d060-978d-e063-6294a90ac22dSPL ID 2c4d9d53-d060-978d-e063-6294a90ac22dSPL set ID f6dc463b-3601-48c0-e053-6294a90a2d77RxCUI 856853UNII 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
N472189044430followed by a unit qualifier and the quantityPackage 72189-0444-30. 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)
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 214548
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 | Proficient Rx LP | 82804-092 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-100 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3621 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3641 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 10 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-556 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-823 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6313 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 50 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6315 |
| Amitriptyline HCL | Amitriptyline hydrochloride 150 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-622 |
| Amitriptyline HCl | Amitriptyline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-420 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-695 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 10 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-693 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-694 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 75 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-696 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-697 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 150 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-698 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 25 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-305 |
| Amitriptyline HCL | Amitriptyline hydrochloride 10 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-431 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6418 |
| Amitriptyline HCL | Amitriptyline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-440 |
Showing 20 of 39.