Amitriptyline Hydrochloride
- Product NDC
- 80425-0386
- 11-digit product format
- 804250386
- Labeler code
- 80425
- Product ID
- 80425-0386_18ff1cbe-c15c-347b-e063-6394a90ae6a8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA214548
- Marketing category
- ANDA
- Marketing start
- 2024-05-21
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 10 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 | 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 |
|---|
| 80425-0386-1 | Amitriptyline Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 80425-0386-2 | Amitriptyline Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 80425-0386-3 | 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 |
|---|
| 80425-0386 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC] | 1 | Current NDC, 3 package rows | 20240601_18ff2901-08fd-37f0-e063-6394a90a1ad2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0386-1 | 80425038601 | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0386-1) | 2024-05-21 | No | No | Historical |
| 80425-0386-2 | 80425038602 | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0386-2) | 2024-05-21 | No | No | Historical |
| 80425-0386-3 | 80425038603 | 90 TABLET, FILM COATED in 1 BOTTLE (80425-0386-3) | 2024-05-21 | No | No | Historical |