Amitriptyline Hydrochloride
- Product NDC
- 76420-696
- 11-digit product format
- 764200696
- Labeler code
- 76420
- Product ID
- 76420-696_12a7cd78-b13d-91e0-e063-6294a90a339b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- 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 | 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 |
|---|
| 76420-696-01 | Amitriptyline Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
| 76420-696-30 | Amitriptyline Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 76420-696-60 | Amitriptyline Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 76420-696-90 | 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 |
|---|
| 76420-696 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ASCLEMED USA, INC.] | 1 | Current NDC, 4 package rows | 20240306_776d2c2c-d897-4da1-a99a-b4324e1f864f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-696-01 | 76420069601 | 100 TABLET, FILM COATED in 1 BOTTLE (76420-696-01) | 2024-03-02 | No | No | Current |
| 76420-696-30 | 76420069630 | 30 TABLET, FILM COATED in 1 BOTTLE (76420-696-30) | 2024-03-02 | No | No | Current |
| 76420-696-60 | 76420069660 | 60 TABLET, FILM COATED in 1 BOTTLE (76420-696-60) | 2024-03-02 | No | No | Current |
| 76420-696-90 | 76420069690 | 90 TABLET, FILM COATED in 1 BOTTLE (76420-696-90) | 2024-03-02 | No | No | Current |