Amitriptyline Hydrochloride
- Product NDC
- 69367-391
- 11-digit product format
- 693670391
- Labeler code
- 69367
- Product ID
- 69367-391_3991983c-6f46-46e2-825c-ed9e5d4c1cb4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Westminster Pharmaceuticals, LLC
- Application
- ANDA212654
- Marketing category
- ANDA
- Marketing start
- 2024-05-20
- 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 Hydrochloride
- 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 | 856762, 856773, 856783, 856834, 856845, 856853 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69367-391-01 | Amitriptyline Hydrochloride | 100 in 1 BOTTLE | TABLET, COATED | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69367-391 | AMITRIPTYLINE HYDROCHLORIDE TABLET, COATED [WESTMINSTER PHARMACEUTICALS, LLC] | 1 | Current NDC, 1 package rows | 20240526_d46ff585-7082-4a7c-a88f-2acf3be0f1d5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 69367-391-01 | 69367039101 | 100 TABLET, COATED in 1 BOTTLE (69367-391-01) | 2024-05-20 | No | No | Current |