NORTRIPTYLINE HCI
- Product NDC
- 61919-285
- 11-digit product format
- 619190285
- Labeler code
- 61919
- Product ID
- 61919-285_ea4e5146-9c7a-ecaa-e053-2a95a90a2de7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NORTRIPTYLINE HCI
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA075520
- Marketing category
- ANDA
- Marketing start
- 2019-08-22
- Marketing end
- 0000-00-00
- Substance
- NORTRIPTYLINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Tricyclic Antidepressant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| de76de11-1019-6138-2d8a-16fa566ae22a | Product name | 2 | 20241009 |
| 777d68c6-a5ab-e06c-d314-677b0b9af0c8 | Product name | 2 | 20240508 |
| 53e88688-54e1-9681-22b8-e499bd715088 | Product name | 2 | 20210729 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61919-285-30 | 2025-01-30 | C162847 | 48780-1 | 1030e365-5f51-111a-e063-dadaa90a10e2 | Nortriptyline HCL |
| 61919-285-60 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-619b-d83d-e063-dadaa90ab31f | Nortriptyline HCL |
| 61919-285-90 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-624c-d83d-e063-dadaa90ab31f | Nortriptyline HCL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61919-285-30 | NORTRIPTYLINE HCI | 30 in 1 BOTTLE | CAPSULE | 30 | 2 | |
| 61919-285-60 | NORTRIPTYLINE HCI | 60 in 1 BOTTLE | CAPSULE | 60 | 2 | |
| 61919-285-90 | NORTRIPTYLINE HCI | 90 in 1 BOTTLE | CAPSULE | 90 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61919-285-30 | EA - Each | 61919-285 | a509f16b-9bcb-40fc-b3d0-44b8bf2b23a8 | 1 | 2019-04-11 |
| 61919-285-60 | EA - Each | 61919-285 | 5ff4e50b-f581-4159-bf94-f3e588ae2744 | 1 | 2019-09-05 |
| 61919-285-90 | EA - Each | 61919-285 | 14a3ca7f-7ea7-430b-b6f8-5dfae61fa87d | 1 | 2019-09-05 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61919-285 | NORTRIPTYLINE HCI CAPSULE [DIRECT_RX] | 2 | Legacy NDC, 1 package rows | 20221007_90a6bfcf-faf9-21c0-e053-2995a90ad69f.zip |
| 61919-285 | NORTRIPTYLINE HCI CAPSULE [DIRECT_RX] | 2 | Legacy NDC, 1 package rows | 20221007_90b531a8-f70c-1224-e053-2995a90a3550.zip |
| 61919-285 | NORTRIPTYLINE HCL CAPSULE NORTRIPTYLINE HCI CAPSULE [DIRECT_RX] | 2 | Legacy NDC, 1 package rows | 20190328_8024d787-333d-1235-e053-2991aa0a7e4c.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 317136 | nortriptyline HCl 25 MG Oral Capsule | PSN | 8024d787-333d-1235-e053-2991aa0a7e4c | 2 |
| 317136 | nortriptyline HCl 25 MG Oral Capsule | PSN | 90a6bfcf-faf9-21c0-e053-2995a90ad69f | 2 |
| 317136 | nortriptyline HCl 25 MG Oral Capsule | PSN | 90b531a8-f70c-1224-e053-2995a90a3550 | 2 |
| 198046 | nortriptyline HCl 50 MG Oral Capsule | PSN | 8024d787-333d-1235-e053-2991aa0a7e4c | 2 |
| 317136 | nortriptyline 25 MG Oral Capsule | SCD | 8024d787-333d-1235-e053-2991aa0a7e4c | 2 |
| 317136 | nortriptyline 25 MG Oral Capsule | SCD | 90a6bfcf-faf9-21c0-e053-2995a90ad69f | 2 |
| 317136 | nortriptyline 25 MG Oral Capsule | SCD | 90b531a8-f70c-1224-e053-2995a90a3550 | 2 |
| 198046 | nortriptyline 50 MG Oral Capsule | SCD | 8024d787-333d-1235-e053-2991aa0a7e4c | 2 |
| 317136 | nortriptyline (as nortriptyline HCl) 25 MG Oral Capsule | SY | 8024d787-333d-1235-e053-2991aa0a7e4c | 2 |
| 317136 | nortriptyline (as nortriptyline HCl) 25 MG Oral Capsule | SY | 90a6bfcf-faf9-21c0-e053-2995a90ad69f | 2 |
| 317136 | nortriptyline (as nortriptyline HCl) 25 MG Oral Capsule | SY | 90b531a8-f70c-1224-e053-2995a90a3550 | 2 |
| 198046 | nortriptyline (as nortriptyline HCl) 50 MG Oral Capsule | SY | 8024d787-333d-1235-e053-2991aa0a7e4c | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61919-285-30 | 61919028530 | 30 CAPSULE in 1 BOTTLE (61919-285-30) | 30 capsule | 2019-03-11 | 0000-00-00 | No | No | Current |
| 61919-285-60 | 61919028560 | 60 CAPSULE in 1 BOTTLE (61919-285-60) | 60 capsule | 2019-08-22 | 0000-00-00 | No | No | Current |
| 61919-285-90 | 61919028590 | 90 CAPSULE in 1 BOTTLE (61919-285-90) | 90 capsule | 2019-08-21 | 0000-00-00 | No | No | Current |