Amitriptyline Hydrochloride
- Product NDC
- 70518-3621
- 11-digit product format
- 705183621
- Labeler code
- 70518
- Product ID
- 70518-3621_4f6c0463-dde4-5040-e063-6294a90af47e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA214548
- Marketing category
- ANDA
- Marketing start
- 2023-01-25
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 26LUD4JO9K |
| Rxcui | 856783 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3621-0 | Amitriptyline Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 7 |
| 70518-3621-1 | Amitriptyline Hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 7 |
| 70518-3621-2 | Amitriptyline Hydrochloride | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 7 |
| 70518-3621-3 | Amitriptyline Hydrochloride | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3621 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.] | 4 | Current NDC, 4 package rows | 20241012_abf6a3f5-0df9-4b23-995d-63b973ef80c1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-3621-0 | 70518362100 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3621-0) | 2023-01-25 | No | No | Historical |
| 70518-3621-1 | 70518362101 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3621-1) | 2023-01-28 | No | No | Historical |
| 70518-3621-2 | 70518362102 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3621-2) | 2023-05-05 | No | No | Historical |
| 70518-3621-3 | 70518362103 | 60 in 1 BOTTLE, PLASTIC | | | | Historical |