Amitriptyline Hydrochloride
- Product NDC
- 51655-969
- 11-digit product format
- 516550969
- Labeler code
- 51655
- Product ID
- 51655-969_4bcf1377-0596-1300-e063-6294a90a9d14
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA213999
- Marketing category
- ANDA
- Marketing start
- 2023-02-28
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 25 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 | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 26LUD4JO9K |
| Rxcui | 856834 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 51655-969-26 | 51655096926 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-969-26) | 2023-02-28 | No | No | Historical |
| 51655-969-52 | 51655096952 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-969-52) | 2023-02-28 | No | No | Historical |