Amitriptyline Hydrochloride
- Product NDC
- 82804-048
- 11-digit product format
- 828040048
- Labeler code
- 82804
- Product ID
- 82804-048_6dc9d113-1156-43ec-a7eb-253c2ff6bcfa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA214548
- Marketing category
- ANDA
- Marketing start
- 2021-05-26
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 75 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 | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 26LUD4JO9K |
| Rxcui | 856853 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82804-048-30 | Amitriptyline Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 82804-048-60 | Amitriptyline Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 82804-048-90 | 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 |
|---|
| 82804-048 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | Current NDC, 3 package rows | 20231223_6dc9d113-1156-43ec-a7eb-253c2ff6bcfa.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-048-30 | 82804004830 | 30 TABLET, FILM COATED in 1 BOTTLE (82804-048-30) | 2023-12-21 | No | No | Current |
| 82804-048-60 | 82804004860 | 60 TABLET, FILM COATED in 1 BOTTLE (82804-048-60) | 2023-12-21 | No | No | Current |
| 82804-048-90 | 82804004890 | 90 TABLET, FILM COATED in 1 BOTTLE (82804-048-90) | 2023-12-21 | No | No | Current |