Amitriptyline Hydrochloride
- Product NDC
- 16714-257
- 11-digit product format
- 167140257
- Labeler code
- 16714
- Product ID
- 16714-257_f089e8f9-aed0-4f80-812d-35a969447345
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Northstar Rx LLC.
- Application
- ANDA210086
- Marketing category
- ANDA
- Marketing start
- 2021-08-25
- 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 | 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 |
|---|
| 16714-257-01 | Amitriptyline Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 4 |
| 16714-257-02 | Amitriptyline Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-257 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250418_8ed28f42-e41a-45ca-a86f-849ebeb6ab80.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 |
|---|
| 16714-257-01 | 16714025701 | 100 TABLET, FILM COATED in 1 BOTTLE (16714-257-01) | 2021-08-25 | 0000-00-00 | No | No | Current |
| 16714-257-02 | 16714025702 | 1000 TABLET, FILM COATED in 1 BOTTLE (16714-257-02) | 2021-08-25 | 0000-00-00 | No | No | Current |