Amitriptyline HCL
- Product NDC
- 72189-444
- 11-digit product format
- 721890444
- Labeler code
- 72189
- Product ID
- 72189-444_2c4d9d53-d060-978d-e063-6294a90ac22d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline HCL
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA214548
- Marketing category
- ANDA
- Marketing start
- 2023-03-14
- 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 HCL
- 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 |
|---|
| 72189-444-30 | Amitriptyline HCL | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-444 | AMITRIPTYLINE HCL TABLET, FILM COATED [DIRECT_RX] | 2 | Current NDC, 1 package rows | 20250123_f6dc463b-3601-48c0-e053-6294a90a2d77.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72189-444-30 | 72189044430 | 30 TABLET, FILM COATED in 1 BOTTLE (72189-444-30) | 2023-03-14 | No | No | Current |