Amitriptyline Hydrochloride
- Product NDC
- 50268-040
- 11-digit product format
- 502680040
- Labeler code
- 50268
- Product ID
- 50268-040_2b489f9d-de0e-dd7a-e063-6394a90a8571
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA214548
- Marketing category
- ANDA
- Marketing start
- 2023-06-06
- 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 | 856783, 856834, 856845, 856853 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50268-040-11 | Amitriptyline Hydrochloride | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 2 |
| 50268-040-15 | Amitriptyline Hydrochloride | 50 in 1 BOX | TABLET, FILM COATED | 50 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50268-040 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AVPAK] | 2 | Current NDC, 2 package rows | 20250112_fd771b4b-c7ae-8e69-e053-6294a90a2120.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 |
|---|
| 50268-040-11 | 50268004011 | 1 in 1 BLISTER PACK | | | | | Historical |
| 50268-040-15 | 50268004015 | 50 BLISTER PACK in 1 BOX (50268-040-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-040-11) | 50 blister pack | 2023-06-06 | No | No | Current |