Amitriptyline Hydrochloride
- Product NDC
- 68788-8363
- 11-digit product format
- 687888363
- Labeler code
- 68788
- Product ID
- 68788-8363_18c58a61-e63d-43f0-9597-47202ecf8aca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA214548
- Marketing category
- ANDA
- Marketing start
- 2023-02-01
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Tricyclic Antidepressant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amitriptyline Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMITRIPTYLINE HYDROCHLORIDE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 26LUD4JO9K |
| Rxcui | 856845 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8363-3 | Amitriptyline Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 68788-8363-6 | Amitriptyline Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 4 |
| 68788-8363-8 | Amitriptyline Hydrochloride | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | | 4 |
| 68788-8363-9 | Amitriptyline Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8363 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] | 3 | Current NDC, 4 package rows | 20250122_6f0c2fd1-0e0d-4f5f-80c4-266fcee09fa8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8363-3 | 68788836303 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8363-3) | 2023-02-01 | No | No | Current |
| 68788-8363-6 | 68788836306 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8363-6) | 2023-02-01 | No | No | Current |
| 68788-8363-8 | 68788836308 | 28 TABLET, FILM COATED in 1 BOTTLE (68788-8363-8) | 2023-02-01 | No | No | Current |
| 68788-8363-9 | 68788836309 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8363-9) | 2023-02-01 | No | No | Current |