Amitriptyline Hydrochloride
- Product NDC
- 16571-110
- 11-digit product format
- 165710110
- Labeler code
- 16571
- Product ID
- 16571-110_a83b8840-dd78-46f1-b952-893c30bf5bf9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA217411
- Marketing category
- ANDA
- Marketing start
- 2023-06-10
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 150 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 | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 26LUD4JO9K |
| Rxcui | 856762, 856773, 856783, 856834, 856845, 856853 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16571-110-01 | Amitriptyline Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16571-110 | AMITRIPTYLINE HYDROCHLORIDE TABLET [RISING PHARMA HOLDINGS, INC.] | 2 | Current NDC, 1 package rows | 20250523_a219a68e-7ce5-4e9d-a0de-ec76960040f6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 16571-110-01 | 16571011001 | 100 TABLET in 1 BOTTLE (16571-110-01) | 100 tablet | 2023-06-10 | No | No | Current |