Amitriptyline HCL
- Product NDC
- 72189-431
- 11-digit product format
- 721890431
- Labeler code
- 72189
- Product ID
- 72189-431_4c4bca55-969f-d933-e063-6394a90ab8df
- 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
- 2023-03-13
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Tricyclic Antidepressant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amitriptyline HCL
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMITRIPTYLINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 26LUD4JO9K |
| Rxcui | 856783 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72189-431-30 | Amitriptyline HCL | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 7 |
| 72189-431-60 | Amitriptyline HCL | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 7 |
| 72189-431-90 | Amitriptyline HCL | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-431 | AMITRIPTYLINE HCL TABLET, FILM COATED [DIRECT_RX] | 6 | Current NDC, 3 package rows | 20250403_f6c88d87-66bb-2962-e053-6294a90acfbe.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72189-431-30 | 72189043130 | 30 TABLET, FILM COATED in 1 BOTTLE (72189-431-30) | 2023-03-13 | No | No | Current |
| 72189-431-60 | 72189043160 | 60 TABLET, FILM COATED in 1 BOTTLE (72189-431-60) | 2023-03-13 | No | No | Current |
| 72189-431-90 | 72189043190 | 90 TABLET, FILM COATED in 1 BOTTLE (72189-431-90) | 2023-03-13 | No | No | Current |