Amitriptyline Hydrochloride
- Product NDC
- 70518-3641
- 11-digit product format
- 705183641
- Labeler code
- 70518
- Product ID
- 70518-3641_4f6dfa4f-bce0-3eb5-e063-6394a90aca9e
- 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
- 2023-02-14
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3641-0 | Amitriptyline Hydrochloride | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 6 |
| 70518-3641-1 | Amitriptyline Hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 6 |
| 70518-3641-2 | Amitriptyline Hydrochloride | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3641 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.] | 3 | Current NDC, 3 package rows | 20240328_c66e9088-4f34-4b97-971e-5272b45cfc97.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-3641-0 | 70518364100 | 30 in 1 BLISTER PACK | | | | Historical |
| 70518-3641-1 | 70518364101 | 90 in 1 BOTTLE, PLASTIC | | | | Historical |
| 70518-3641-2 | 70518364102 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3641-2) | 2025-08-13 | No | No | Historical |