Amitriptyline Hydrochloride
- Product NDC
- 68788-8218
- 11-digit product format
- 687888218
- Labeler code
- 68788
- Product ID
- 68788-8218_82d00754-2c99-43ed-af8b-7cfa29e8df32
- 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
- 2022-09-08
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 26LUD4JO9K |
| Rxcui | 856783 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8218-3 | Amitriptyline Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
| 68788-8218-6 | Amitriptyline Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 5 |
| 68788-8218-9 | Amitriptyline Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8218 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] | 4 | Current NDC, Legacy NDC, 3 package rows | 20250124_5dd07852-43a5-415c-863e-1202f82b5654.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-8218-3 | 68788821803 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8218-3) | 2022-09-08 | 0000-00-00 | No | No | Current |
| 68788-8218-6 | 68788821806 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8218-6) | 2022-09-08 | 0000-00-00 | No | No | Current |
| 68788-8218-9 | 68788821809 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8218-9) | 2022-09-08 | 0000-00-00 | No | No | Current |