Prescription drug · ANDA
Amitriptyline Hydrochloride NDC 72888-069
Amitriptyline hydrochloride 50 mg/1 · Tablet, Film coated · Oral · Advagen Pharma Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72888-069-00 | 72888006900 | 1000 TABLET, FILM COATED in 1 BOTTLE (72888-069-00)Marketed from May 1, 2023 | |
| 72888-069-01 | 72888006901 | 100 TABLET, FILM COATED in 1 BOTTLE (72888-069-01)Marketed from May 1, 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 Hydrochloride
- Generic name (nonproprietary)
- amitriptyline hydrochloride
- Active ingredients
- Amitriptyline hydrochloride — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Advagen Pharma LtdNDC labeler code 72888
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215376
- Marketing start
- Listing expires
- Identifiers
- Product ID 72888-069_451e8ad6-a78e-429b-e063-6394a90a2bdbSPL ID 451e8ad6-a78e-429b-e063-6394a90a2bdbSPL set ID 651bd090-a420-4dd8-89b0-4cb766c144c2RxCUI 856762, 856773, 856783, 856834, 856845, 856853UNII 26LUD4JO9KUPC 0372888067001, 0372888072012, 0372888071015, 0372888070018, 0372888067018, 0372888069012, 0372888071039, 0372888069005, 0372888068008
- 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
N472888006900followed by a unit qualifier and the quantityPackage 72888-0069-00. 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.
About NDC 72888-069
- What is NDC 72888-069?
- 72888-069 is the product NDC for Amitriptyline Hydrochloride, Amitriptyline hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by Advagen Pharma Ltd. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Amitriptyline Hydrochloride.
- What is the active ingredient?
- Amitriptyline hydrochloride.
- Who is the labeler?
- Advagen Pharma Ltd, NDC labeler code 72888. 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 Hydrochloride?
- 202 other product NDCs are listed under this name. See all Amitriptyline Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Amitriptyline Hydrochloride 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 Hydrochloride | Amitriptyline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0689 | 67046-0689-03 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1694 | 67046-1694-03 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 150 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1671 | 67046-1671-03 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0764 | 67046-0764-03 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1669 | 67046-1669-03 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-818 | 59651-0818-0159651-0818-99 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-819 | 59651-0819-0159651-0819-99 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 75 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-820 | 59651-0820-01 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-821 | 59651-0821-0159651-0821-60 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 150 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-822 | 59651-0822-01 |
Other NDCs under ANDA 215376
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 | Advagen Pharma Ltd | 72888-067 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Advagen Pharma Ltd | 72888-068 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 75 mg/1 | Tablet, Film coatedOral | Advagen Pharma Ltd | 72888-070 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Advagen Pharma Ltd | 72888-071 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 150 mg/1 | Tablet, Film coatedOral | Advagen Pharma Ltd | 72888-072 |