Prescription drug · ANDA
Amitriptyline HCL NDC 72189-588
Amitriptyline hydrochloride 150 mg/1 · Tablet, Film coated · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-588-30 | 7218905883072189058830 | 30 TABLET, FILM COATED in 1 BOTTLE (72189-588-30)Marketed from Oct 4, 2024 |
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 — 150 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Direct_RxNDC labeler code 72189
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213999
- Marketing start
- Listing expires
- Identifiers
- Product ID 72189-588_23ab2afe-06c2-fa61-e063-6394a90abcf8SPL ID 23ab2afe-06c2-fa61-e063-6394a90abcf8SPL set ID 23ab2afe-06c1-fa61-e063-6394a90abcf8RxCUI 856773UNII 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
N472189058830followed by a unit qualifier and the quantityPackage 72189-0588-30. 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.
About NDC 72189-588
- What is NDC 72189-588?
- 72189-588 is the product NDC for Amitriptyline HCL, Amitriptyline hydrochloride 150 mg/1 tablet, film coated, listed with the FDA by Direct_Rx. It has 1 package NDC, 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?
- Direct_Rx, NDC labeler code 72189. 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 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 |
| Amitriptyline HCL | Amitriptyline hydrochloride 10 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0172 | 80425-0172-0180425-0172-02 |
Other NDCs under ANDA 213999
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 | Northwind Health Company, LLC | 51655-084 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-334 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-969 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1669 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 10 mg/1 | Tablet, Film coatedOral | Lifestar Pharma LLC | 70756-201 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Lifestar Pharma LLC | 70756-202 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Lifestar Pharma LLC | 70756-203 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 75 mg/1 | Tablet, Film coatedOral | Lifestar Pharma LLC | 70756-204 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Lifestar Pharma LLC | 70756-205 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 150 mg/1 | Tablet, Film coatedOral | Lifestar Pharma LLC | 70756-206 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 150 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-9710 |