Nortriptyline Hydrochloride
- Product NDC
- 67544-078
- 11-digit product format
- 675440078
- Labeler code
- 67544
- Product ID
- 67544-078_00c8012b-9b3c-44b9-8f0e-be0b6cef2bec
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nortriptyline Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA074132
- Marketing category
- ANDA
- Marketing start
- 1995-04-06
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67544-078-30 | Nortriptyline Hydrochloride | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 3 |
| 67544-078-53 | Nortriptyline Hydrochloride | 60 in 1 BOTTLE, PLASTIC | CAPSULE | 60 | | 3 |
| 67544-078-60 | Nortriptyline Hydrochloride | 90 in 1 BOTTLE, PLASTIC | CAPSULE | 90 | | 3 |
| 67544-078-70 | Nortriptyline Hydrochloride | 120 in 1 BOTTLE, PLASTIC | CAPSULE | 120 | | 3 |
| 67544-078-80 | Nortriptyline Hydrochloride | 180 in 1 BOTTLE, PLASTIC | CAPSULE | 180 | | 3 |
| 67544-078-92 | Nortriptyline Hydrochloride | 270 in 1 BOTTLE, PLASTIC | CAPSULE | 270 | | 3 |
| 67544-078-94 | Nortriptyline Hydrochloride | 360 in 1 BOTTLE, PLASTIC | CAPSULE | 360 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NORTRIPTYLINE HYDROCHLORIDE | ACTIVE INGREDIENT | 00FN6IH15D | NORTRIPTYLINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| NORTRIPTYLINE | ACTIVE MOIETY | BL03SY4LXB | NORTRIPTYLINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | NORTRIPTYLINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | NORTRIPTYLINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | NORTRIPTYLINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | NORTRIPTYLINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | NORTRIPTYLINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | NORTRIPTYLINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | NORTRIPTYLINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | NORTRIPTYLINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | NORTRIPTYLINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | NORTRIPTYLINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | NORTRIPTYLINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | NORTRIPTYLINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | NORTRIPTYLINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | NORTRIPTYLINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | NORTRIPTYLINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | NORTRIPTYLINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67544-078 | NORTRIPTYLINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | Legacy NDC, 7 package rows | 20191224_e1f5e650-e83f-4343-a025-fc90f645a796.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67544-078-30 | 67544007830 | 30 CAPSULE in 1 BOTTLE, PLASTIC (67544-078-30) | 30 capsule | 2004-06-26 | 0000-00-00 | No | No | Current |
| 67544-078-53 | 67544007853 | 60 CAPSULE in 1 BOTTLE, PLASTIC (67544-078-53) | 60 capsule | 2004-06-12 | 0000-00-00 | No | No | Current |
| 67544-078-60 | 67544007860 | 90 CAPSULE in 1 BOTTLE, PLASTIC (67544-078-60) | 90 capsule | 2004-06-12 | 0000-00-00 | No | No | Current |
| 67544-078-70 | 67544007870 | 120 CAPSULE in 1 BOTTLE, PLASTIC (67544-078-70) | 120 capsule | 2009-02-23 | 0000-00-00 | No | No | Current |
| 67544-078-80 | 67544007880 | 180 CAPSULE in 1 BOTTLE, PLASTIC (67544-078-80) | 180 capsule | 2009-02-23 | 0000-00-00 | No | No | Current |
| 67544-078-92 | 67544007892 | 270 CAPSULE in 1 BOTTLE, PLASTIC (67544-078-92) | 270 capsule | 2006-08-17 | 0000-00-00 | No | No | Current |
| 67544-078-94 | 67544007894 | 360 CAPSULE in 1 BOTTLE, PLASTIC (67544-078-94) | 360 capsule | 2006-08-17 | 0000-00-00 | No | No | Current |