AMITRIPTYLINE HYDROCHLORIDE
- Product NDC
- 59651-820
- 11-digit product format
- 596510820
- Labeler code
- 59651
- Product ID
- 59651-820_8085a37f-3c76-4f74-aab3-9a929a7eb1c2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMITRIPTYLINE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA086009
- Marketing category
- ANDA
- Marketing start
- 2026-03-20
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 75 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 HYDROCHLORIDE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMITRIPTYLINE HYDROCHLORIDE | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 26LUD4JO9K |
| Rxcui | 856762, 856773, 856834, 856845, 856853 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-820-01 | AMITRIPTYLINE HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-820-01 | 59651082001 | 100 TABLET, FILM COATED in 1 BOTTLE (59651-820-01) | 2026-03-20 | No | No | Current |