Prescription drug · NDA
Pamelor (nortriptyline hydrochloride) NDC 0406-9912
Nortriptyline hydrochloride 50 mg/1 · Capsule · Oral · SpecGx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0406-9912-03 | 00406991203 | 30 CAPSULE in 1 BOTTLE (0406-9912-03)Marketed from Aug 1, 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)
- Pamelor
- Generic name (nonproprietary)
- nortriptyline hydrochloride
- Active ingredients
- Nortriptyline hydrochloride — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- SpecGx LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018013
- Marketing start
- Marketing end
- Identifiers
- Product ID 0406-9912_0c3b20b3-e852-4959-815a-90ed989a30e1SPL ID 0c3b20b3-e852-4959-815a-90ed989a30e1SPL set ID e17dc299-f52d-414d-ab6e-e809bd6f8acbRxCUI 198045, 198046, 198047, 209329, 209339, 209350, 209391, 317136UNII 00FN6IH15DUPC 0304069911032, 0304069910035, 0304069912039, 0304069913036
- 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
N400406991203followed by a unit qualifier and the quantityPackage 00406-9912-03. 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 Pamelor™ (nortriptyline HCl) is 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 NDA 018013
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 |
|---|---|---|---|---|
| Pamelornortriptyline hydrochloride | Nortriptyline hydrochloride 10 mg/1 | CapsuleOral | SpecGx LLC | 0406-9910 |
| Pamelornortriptyline hydrochloride | Nortriptyline hydrochloride 25 mg/1 | CapsuleOral | SpecGx LLC | 0406-9911 |
| Pamelornortriptyline hydrochloride | Nortriptyline hydrochloride 75 mg/1 | CapsuleOral | SpecGx LLC | 0406-9913 |