Amitriptyline Hydrochloride
- Product NDC
- 50090-6925
- 11-digit product format
- 500906925
- Labeler code
- 50090
- Product ID
- 50090-6925_f30de206-e7b1-4631-bc41-5588df1bd047
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA210086
- Marketing category
- ANDA
- Marketing start
- 2021-08-25
- Substance
- AMITRIPTYLINE 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
- Amitriptyline Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMITRIPTYLINE HYDROCHLORIDE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 26LUD4JO9K |
| Rxcui | 856834 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-6925-0 | Amitriptyline Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 50090-6925-1 | Amitriptyline Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
| 50090-6925-4 | Amitriptyline Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 50090-6925-8 | Amitriptyline Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-6925 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 1 | Current NDC, 4 package rows | 20231219_d22879c5-925a-42e0-9d48-55a422192983.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-6925-0 | 50090692500 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-6925-0) | 2023-12-14 | No | No | Current |
| 50090-6925-1 | 50090692501 | 100 TABLET, FILM COATED in 1 BOTTLE (50090-6925-1) | 2023-12-14 | No | No | Current |
| 50090-6925-4 | 50090692504 | 60 TABLET, FILM COATED in 1 BOTTLE (50090-6925-4) | 2023-12-14 | No | No | Current |
| 50090-6925-8 | 50090692508 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6925-8) | 2023-12-14 | No | No | Current |