Prescription drug · ANDA
Nortriptyline Hydrochloride NDC 70771-1613
Nortriptyline hydrochloride 25 mg/1 · Capsule · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1613-1 | 70771161301 | 100 CAPSULE in 1 BOTTLE (70771-1613-1)Marketed from Feb 10, 2022 | |
| 70771-1613-3 | 70771161303 | 30 CAPSULE in 1 BOTTLE (70771-1613-3)Marketed from Feb 10, 2022 | |
| 70771-1613-5 | 70771161305 | 500 CAPSULE in 1 BOTTLE (70771-1613-5)Marketed from Feb 10, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Nortriptyline Hydrochloride
- Generic name (nonproprietary)
- nortriptyline hydrochloride
- Active ingredients
- Nortriptyline hydrochloride — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213441
- Marketing start
- Listing expires
- Identifiers
- Product ID 70771-1613_b2965133-3b71-4cdb-8676-235882e57bebSPL ID b2965133-3b71-4cdb-8676-235882e57bebSPL set ID f22dce73-b895-4fe2-8cf7-816dca93c246RxCUI 198045, 198046, 198047, 317136UNII 00FN6IH15DUPC 0370771161331
- 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
N470771161301followed by a unit qualifier and the quantityPackage 70771-1613-01. 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 Nortriptyline hydrochloride capsules are indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213441
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 |
|---|---|---|---|---|
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 50 mg/1 | CapsuleOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1155 |
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 10 mg/1 | CapsuleOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1153 |
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 25 mg/1 | CapsuleOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1154 |
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 10 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1612 |
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 50 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1614 |
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 75 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1615 |
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 75 mg/1 | CapsuleOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1156 |