Amitriptyline Hydrochloride
- Product NDC
- 50090-7599
- 11-digit product format
- 500907599
- Labeler code
- 50090
- Product ID
- 50090-7599_2f5fe8de-9178-4691-8678-2b20ff8d8d27
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA212654
- Marketing category
- ANDA
- Marketing start
- 2024-05-20
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 50 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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 26LUD4JO9K |
| Rxcui | 856845 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-7599-0 | Amitriptyline Hydrochloride | 100 in 1 BOTTLE | TABLET, COATED | 100 | | 3 |
| 50090-7599-1 | Amitriptyline Hydrochloride | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 3 |
| 50090-7599-2 | Amitriptyline Hydrochloride | 60 in 1 BOTTLE | TABLET, COATED | 60 | | 3 |
| 50090-7599-5 | Amitriptyline Hydrochloride | 90 in 1 BOTTLE | TABLET, COATED | 90 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-7599-0 | 50090759900 | 100 TABLET, COATED in 1 BOTTLE (50090-7599-0) | 2025-07-09 | No | No | Historical |
| 50090-7599-1 | 50090759901 | 30 TABLET, COATED in 1 BOTTLE (50090-7599-1) | 2025-07-09 | No | No | Historical |
| 50090-7599-2 | 50090759902 | 60 TABLET, COATED in 1 BOTTLE (50090-7599-2) | 2025-07-09 | No | No | Historical |
| 50090-7599-5 | 50090759905 | 90 TABLET, COATED in 1 BOTTLE (50090-7599-5) | 2025-07-09 | No | No | Historical |