Prescription drug · ANDA
Amitriptyline Hydrochloride NDC 0904-7411
Amitriptyline hydrochloride 50 mg/1 · Tablet · Oral · Major Pharmaceuticals
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0904-7411Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-7411Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7411-61 | 00904741161 | 100 BLISTER PACK in 1 CARTON (0904-7411-61) / 1 TABLET in 1 BLISTER PACKMarketed from Mar 8, 2024 |
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 — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217411
- Marketing start
- Listing expires
- Identifiers
- Product ID 0904-7411_54771c13-f83b-4c28-b2ed-be967b14d388SPL ID 54771c13-f83b-4c28-b2ed-be967b14d388SPL set ID 29ec1221-04d8-4b21-822e-2779fcaae62cRxCUI 856834, 856845UNII 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
N400904741161followed by a unit qualifier and the quantityPackage 00904-7411-61. 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 0904-7411
- What is NDC 0904-7411?
- 0904-7411 is the product NDC for Amitriptyline Hydrochloride, Amitriptyline hydrochloride 50 mg/1 tablet, listed with the FDA by Major Pharmaceuticals. 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?
- Major Pharmaceuticals, NDC labeler code 0904. 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 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 100 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-821 | 59651-0821-0159651-0821-60 |
| 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 150 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-822 | 59651-0822-01 |
Other NDCs under ANDA 217411
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 25 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7410 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 100 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4052 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 50 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2491 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 25 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0395 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 50 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4048 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 100 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4054 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 75 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4365 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 25 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4088 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 25 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8691 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 50 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0434 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 100 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0439 |
| Amitriptyline HCL | Amitriptyline hydrochloride 100 mg/1 | TabletOral | Direct_rx | 72189-581 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-7583 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-7598 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 50 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8767 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 75 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8788 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 100 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2374 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 25 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-685 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 50 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-686 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 10 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-105 |
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