Amitriptyline Hydrochloride
- Product NDC
- 0904-7411
- 11-digit product format
- 009047411
- Labeler code
- 0904
- Product ID
- 0904-7411_54771c13-f83b-4c28-b2ed-be967b14d388
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA217411
- Marketing category
- ANDA
- Marketing start
- 2024-03-08
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 50 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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 26LUD4JO9K |
| Rxcui | 856834, 856845 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7411-61 | Amitriptyline Hydrochloride | 1 in 1 BLISTER PACK | TABLET | 1 | | 2 |
| 0904-7411-61 | Amitriptyline Hydrochloride | 100 in 1 CARTON | TABLET | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7411 | AMITRIPTYLINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS] | 1 | Current NDC, 2 package rows | 20240404_29ec1221-04d8-4b21-822e-2779fcaae62c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0904-7411-61 | 00904741161 | 100 BLISTER PACK in 1 CARTON (0904-7411-61) / 1 TABLET in 1 BLISTER PACK | 100 blister pack | 2024-03-08 | No | No | Current |