Nortriptyline Hydrochloride
- Product NDC
- 72789-425
- 11-digit product format
- 727890425
- Labeler code
- 72789
- Product ID
- 72789-425_4123bbc5-c72a-e70d-e063-6294a90a2fb4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nortriptyline Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA073556
- Marketing category
- ANDA
- Marketing start
- 2023-11-17
- 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
- 2026-12-31
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 |
|---|
| 72789-425-30 | Nortriptyline Hydrochloride | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-425 | NORTRIPTYLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 2 | Current NDC, 1 package rows | 20240808_dbb3cc4d-c36d-495d-b9fc-e5513b2f6b93.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72789-425-30 | 72789042530 | 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-425-30) | 30 capsule | 2024-08-07 | No | No | Current |