Nortriptyline Hydrochloride
- Product NDC
- 70518-4086
- 11-digit product format
- 705184086
- Labeler code
- 70518
- Product ID
- 70518-4086_3fa3ddf9-13ce-acd5-e063-6394a90a47fe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nortriptyline Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA073556
- Marketing category
- ANDA
- Marketing start
- 2024-05-25
- Substance
- NORTRIPTYLINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Tricyclic Antidepressant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nortriptyline Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NORTRIPTYLINE HYDROCHLORIDE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 00FN6IH15D |
| Rxcui | 317136 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4086-0 | Nortriptyline Hydrochloride | 30 in 1 BLISTER PACK | CAPSULE | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4086 | NORTRIPTYLINE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.] | 1 | Current NDC, 1 package rows | 20240529_27e96d6c-b311-45d2-b879-65c6a4efcfba.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4086-0 | 70518408600 | 30 CAPSULE in 1 BLISTER PACK (70518-4086-0) | 30 capsule | 2024-05-25 | No | No | Current |
| 70518-4086-1 | 70518408601 | 50 POUCH in 1 BOX (70518-4086-1) / 1 CAPSULE in 1 POUCH (70518-4086-2) | 50 pouch | 2026-04-24 | 0 | | Current |