Prescription drug · ANDA
Amitriptyline Hydrochloride NDC 0781-1491
Amitriptyline hydrochloride 150 mg/1 · Tablet, Film coated · Oral · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-1491-01 | 00781149101 | 100 TABLET, FILM COATED in 1 BOTTLE (0781-1491-01)Marketed from Nov 21, 1977 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 150 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Sandoz IncNDC labeler code 0781
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 085968
- Marketing start
- Listing expires
- Identifiers
- Product ID 0781-1491_9df45420-7268-454e-9624-8da48c97b7dbSPL ID 9df45420-7268-454e-9624-8da48c97b7dbSPL set ID 705a2bae-031d-4218-82fe-4346542c0baaRxCUI 856762, 856773, 856783, 856834, 856845, 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
N400781149101followed by a unit qualifier and the quantityPackage 00781-1491-01. 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.
About NDC 0781-1491
- What is NDC 0781-1491?
- 0781-1491 is the product NDC for Amitriptyline Hydrochloride, Amitriptyline hydrochloride 150 mg/1 tablet, film coated, listed with the FDA by Sandoz Inc. It has 1 package NDC, 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?
- Sandoz Inc, NDC labeler code 0781. 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?
- 200 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 100 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1694 | 67046-1694-03 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0689 | 67046-0689-03 |
| 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 085968
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 | Sandoz Inc | 0781-1486 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Sandoz Inc | 0781-1487 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Sandoz Inc | 0781-1488 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 75 mg/1 | Tablet, Film coatedOral | Sandoz Inc | 0781-1489 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Sandoz Inc | 0781-1490 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 25 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-822 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 50 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-836 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 82868-086 |