Prescription drug · ANDA
Nortriptyline Hydrochloride NDC 76420-912
Nortriptyline hydrochloride 50 mg/1 · Capsule · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)76420-912Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76420-0912Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-912-01 | 7642009120176420091201 | 100 CAPSULE in 1 BOTTLE, PLASTIC (76420-912-01)Marketed from Jan 28, 2025 | |
| 76420-912-05 | 7642009120576420091205 | 500 CAPSULE in 1 BOTTLE, PLASTIC (76420-912-05)Marketed from Jan 28, 2025 | |
| 76420-912-30 | 7642009123076420091230 | 30 CAPSULE in 1 BOTTLE, PLASTIC (76420-912-30)Marketed from Jan 28, 2025 | |
| 76420-912-60 | 7642009126076420091260 | 60 CAPSULE in 1 BOTTLE, PLASTIC (76420-912-60)Marketed from Jan 28, 2025 | |
| 76420-912-90 | 7642009129076420091290 | 90 CAPSULE in 1 BOTTLE, PLASTIC (76420-912-90)Marketed from Jan 28, 2025 |
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 Hydrochloride
- Generic name (nonproprietary)
- nortriptyline hydrochloride
- Active ingredients
- Nortriptyline hydrochloride — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Asclemed USA, Inc.NDC labeler code 76420
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 073556
- Marketing start
- Listing expires
- Identifiers
- Product ID 76420-912_2cbda9e6-b8cc-1364-e063-6294a90ace66SPL ID 2cbda9e6-b8cc-1364-e063-6294a90ace66SPL set ID b02eb04a-83ee-45b0-b755-187fde2698c3RxCUI 198045, 198046, 198047, 317136UNII 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
N476420091201followed by a unit qualifier and the quantityPackage 76420-0912-01. 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, 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 76420-912
- What is NDC 76420-912?
- 76420-912 is the product NDC for Nortriptyline Hydrochloride, Nortriptyline hydrochloride 50 mg/1 capsule, listed with the FDA by Asclemed USA, Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nortriptyline Hydrochloride.
- What is the active ingredient?
- Nortriptyline hydrochloride.
- Who is the labeler?
- Asclemed USA, Inc., NDC labeler code 76420. 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 Hydrochloride?
- 77 other product NDCs are listed under this name. See all Nortriptyline Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nortriptyline 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) |
|---|---|---|---|---|---|
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 10 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4766 | 70518-4766-00 |
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 25 mg/1 | CapsuleOral | Coupler LLC | 67046-1661 | 67046-1661-03 |
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 25 mg/1 | CapsuleOral | American Health Packaging | 60687-911 | 60687-0911-01 |
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 10 mg/1 | CapsuleOral | American Health Packaging | 60687-900 | 60687-0900-01 |
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 25 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-909 | 60760-0909-30 |
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 10 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8900 | 68788-8900-03 |
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 25 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0534 | 80425-0534-0180425-0534-0280425-0534-03 |
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 50 mg/1 | CapsuleOral | Coupler LLC | 67046-1530 | 67046-1530-03 |
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 75 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4281 | 70518-4281-00 |
| Nortriptyline Hydrochloride | Nortriptyline hydrochloride 10 mg/1 | CapsuleOral | Coupler LLC | 67046-1500 | 67046-1500-03 |
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 HCL | Nortriptyline hydrochloride 10 mg/1 | CapsuleOral | Direct_rx | 72189-563 |
| 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 |
Showing 20 of 33.