Prescription drug · ANDA
Amitriptyline Hydrochloride NDC 16571-105
Amitriptyline hydrochloride 10 mg/1 · Tablet · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16571-105-01 | 16571010501 | 100 TABLET in 1 BOTTLE (16571-105-01)Marketed from Jun 10, 2023 | |
| 16571-105-10 | 16571010510 | 1000 TABLET in 1 BOTTLE (16571-105-10)Marketed from Jun 10, 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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217411
- Marketing start
- Listing expires
- Identifiers
- Product ID 16571-105_a83b8840-dd78-46f1-b952-893c30bf5bf9SPL ID a83b8840-dd78-46f1-b952-893c30bf5bf9SPL set ID a219a68e-7ce5-4e9d-a0de-ec76960040f6RxCUI 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
N416571010501followed by a unit qualifier and the quantityPackage 16571-0105-01. 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.
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 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 Hydrochloride | Amitriptyline hydrochloride 75 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8788 |
| 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 100 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2374 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 100 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-109 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 25 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2397 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 150 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-110 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 75 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2398 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 100 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-732 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 25 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3656 |
| 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 50 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4048 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 75 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-108 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 25 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-106 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 50 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-107 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 100 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4054 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 75 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4365 |
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