Prescription drug · ANDA
Nortriptyline HCL NDC 72189-563
Nortriptyline hydrochloride 10 mg/1 · Capsule · Oral · Direct_rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-563-30 | 7218905633072189056330 | 30 CAPSULE in 1 BOTTLE, PLASTIC (72189-563-30)Marketed from Jun 26, 2024 | |
| 72189-563-60 | 7218905636072189056360 | 60 CAPSULE in 1 BOTTLE (72189-563-60)Marketed from Jun 26, 2024 |
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)
- Nortriptyline HCL
- Generic name (nonproprietary)
- nortriptyline hcl
- Active ingredients
- Nortriptyline hydrochloride — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Direct_rxNDC labeler code 72189
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 073556
- Marketing start
- Listing expires
- Identifiers
- Product ID 72189-563_5371dd3f-bc71-e5c6-e063-6394a90a1427SPL ID 5371dd3f-bc71-e5c6-e063-6394a90a1427SPL set ID 1bcf2f7b-974f-54ad-e063-6394a90a28d9RxCUI 198045UNII 00FN6IH15D
- 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
N472189056330followed by a unit qualifier and the quantityPackage 72189-0563-30. 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)
Nortriptyline hydrochloride, USP 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.
About NDC 72189-563
- What is NDC 72189-563?
- 72189-563 is the product NDC for Nortriptyline HCL, Nortriptyline hydrochloride 10 mg/1 capsule, listed with the FDA by Direct_rx. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nortriptyline HCL.
- What is the active ingredient?
- Nortriptyline hydrochloride.
- Who is the labeler?
- Direct_rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nortriptyline HCL?
- 2 other product NDCs are listed under this name. See all Nortriptyline HCL NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nortriptyline HCL products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nortriptyline HCL | Nortriptyline hydrochloride 50 mg/1 | CapsuleOral | Direct_rx | 72189-562 | 72189-0562-3072189-0562-6072189-0562-90 |
| Nortriptyline HCL | Nortriptyline hydrochloride 25 mg/1 | CapsuleOral | Direct_rx | 72189-561 | 72189-0561-3072189-0561-6072189-0561-90 |
Other NDCs under ANDA 073556
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 HCL | Nortriptyline hydrochloride 25 mg/1 | CapsuleOral | Direct_rx | 72189-561 |
| Nortriptyline HCL | Nortriptyline hydrochloride 50 mg/1 | CapsuleOral | Direct_rx | 72189-562 |
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 25 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 43063-722 |
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 25 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7191 |
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 25 mg/1 | CapsuleOral | Mayne Pharma Inc. | 51862-016 |
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 10 mg/1 | CapsuleOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-908 |
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 25 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-909 |
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 25 mg/1 | CapsuleOral | Coupler LLC | 67046-1411 |
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 10 mg/1 | CapsuleOral | Coupler LLC | 67046-1500 |
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 50 mg/1 | CapsuleOral | Coupler LLC | 67046-1530 |
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 25 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8721 |
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 10 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8900 |
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 25 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4086 |
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 50 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4122 |
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 75 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4281 |
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 10 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4766 |
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2350 |
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2351 |
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 75 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2459 |
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 10 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2772 |
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