Amitriptyline Hydrochloride
- Product NDC
- 50090-6313
- 11-digit product format
- 500906313
- Labeler code
- 50090
- Product ID
- 50090-6313_dd76eba0-6e9a-4fb2-8185-87290c800d76
- 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
- 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 |
|---|
| 50090-6313-0 | Amitriptyline Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 50090-6313-1 | Amitriptyline Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 4 |
| 50090-6313-4 | Amitriptyline Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 4 |
| 50090-6313-8 | 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 |
|---|
| 50090-6313 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 4 | Current NDC, Legacy NDC, 4 package rows | 20250226_69c7a0bd-93d0-40fe-a6d3-f41986b802b4.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 |
|---|
| 50090-6313-0 | 50090631300 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-6313-0) | 2023-01-06 | 0000-00-00 | No | No | Current |
| 50090-6313-1 | 50090631301 | 100 TABLET, FILM COATED in 1 BOTTLE (50090-6313-1) | 2023-01-06 | 0000-00-00 | No | No | Current |
| 50090-6313-4 | 50090631304 | 60 TABLET, FILM COATED in 1 BOTTLE (50090-6313-4) | 2023-01-06 | 0000-00-00 | No | No | Current |
| 50090-6313-8 | 50090631308 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6313-8) | 2023-01-06 | 0000-00-00 | No | No | Current |