Amitriptyline Hydrochloride
- Product NDC
- 50090-6315
- 11-digit product format
- 500906315
- Labeler code
- 50090
- Product ID
- 50090-6315_1ab3cc2b-7892-40d7-a440-81c186c2cf40
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA214548
- Marketing category
- ANDA
- Marketing start
- 2021-05-26
- 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 |
|---|
| 50090-6315-0 | Amitriptyline Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 9 |
| 50090-6315-1 | Amitriptyline Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 9 |
| 50090-6315-2 | Amitriptyline Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 9 |
| 50090-6315-5 | Amitriptyline Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-6315 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 7 | Current NDC, Legacy NDC, 4 package rows | 20250321_53f4f83c-4bfd-43d6-9bb8-82c21ed2864f.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 |
|---|
| 50090-6315-0 | 50090631500 | 100 TABLET, FILM COATED in 1 BOTTLE (50090-6315-0) | 2023-01-06 | 0000-00-00 | No | No | Current |
| 50090-6315-1 | 50090631501 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-6315-1) | 2023-01-06 | 0000-00-00 | No | No | Current |
| 50090-6315-2 | 50090631502 | 60 TABLET, FILM COATED in 1 BOTTLE (50090-6315-2) | 2023-01-06 | 0000-00-00 | No | No | Current |
| 50090-6315-5 | 50090631505 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6315-5) | 2023-01-06 | 0000-00-00 | No | No | Current |