Amitriptyline Hydrochloride
- Product NDC
- 50090-7424
- 11-digit product format
- 500907424
- Labeler code
- 50090
- Product ID
- 50090-7424_cfbea0b3-d501-4285-a38f-4ea27877f77b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA212654
- Marketing category
- ANDA
- Marketing start
- 2024-05-20
- 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 |
|---|
| 50090-7424-0 | Amitriptyline Hydrochloride | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 3 |
| 50090-7424-1 | Amitriptyline Hydrochloride | 100 in 1 BOTTLE | TABLET, COATED | 100 | | 3 |
| 50090-7424-6 | Amitriptyline Hydrochloride | 90 in 1 BOTTLE | TABLET, COATED | 90 | | 3 |
| 50090-7424-7 | Amitriptyline Hydrochloride | 60 in 1 BOTTLE | TABLET, COATED | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-7424 | AMITRIPTYLINE HYDROCHLORIDE TABLET, COATED [A-S MEDICATION SOLUTIONS] | 1 | Current NDC, 4 package rows | 20241102_9d00b912-69be-4d9a-8c81-42cfc9bf6e09.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-7424-0 | 50090742400 | 30 TABLET, COATED in 1 BOTTLE (50090-7424-0) | 2024-10-28 | No | No | Historical |
| 50090-7424-1 | 50090742401 | 100 TABLET, COATED in 1 BOTTLE (50090-7424-1) | 2024-10-28 | No | No | Historical |
| 50090-7424-6 | 50090742406 | 90 TABLET, COATED in 1 BOTTLE (50090-7424-6) | 2024-10-28 | No | No | Historical |
| 50090-7424-7 | 50090742407 | 60 TABLET, COATED in 1 BOTTLE (50090-7424-7) | 2024-10-28 | No | No | Historical |