Amitriptyline Hydrochloride
- Product NDC
- 60760-838
- 11-digit product format
- 607600838
- Labeler code
- 60760
- Product ID
- 60760-838_35aa6dbf-04d9-6a1d-e063-6294a90a6afa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- ST. MARY'S MEDICAL PARK PHARMACY
- Application
- ANDA212654
- Marketing category
- ANDA
- Marketing start
- 2024-05-20
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 25 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 | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 26LUD4JO9K |
| Rxcui | 856834 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60760-838-30 | Amitriptyline Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, COATED | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60760-838 | AMITRIPTYLINE HYDROCHLORIDE TABLET, COATED [ST. MARY'S MEDICAL PARK PHARMACY] | 1 | Current NDC, 1 package rows | 20250523_35aa7ab3-321a-97f7-e063-6294a90a91e2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 60760-838-30 | 60760083830 | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (60760-838-30) | 2025-05-15 | No | No | Historical |