Amitriptyline Hydrochloride
- Product NDC
- 70518-4048
- 11-digit product format
- 705184048
- Labeler code
- 70518
- Product ID
- 70518-4048_3fa0e65b-2ab0-3d3f-e063-6294a90af011
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA217411
- Marketing category
- ANDA
- Marketing start
- 2024-04-10
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 50 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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 26LUD4JO9K |
| Rxcui | 856845 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4048-0 | Amitriptyline Hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 4 |
| 70518-4048-1 | Amitriptyline Hydrochloride | 30 in 1 BLISTER PACK | TABLET | 30 | | 4 |
| 70518-4048-2 | Amitriptyline Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4048 | AMITRIPTYLINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] | 2 | Current NDC, 3 package rows | 20240907_5dc3c2d7-60a2-4754-be33-1f9401c925a4.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 |
|---|
| 70518-4048-0 | 70518404800 | 90 in 1 BOTTLE, PLASTIC | | | | | Historical |
| 70518-4048-1 | 70518404801 | 30 TABLET in 1 BLISTER PACK (70518-4048-1) | 30 tablet | 2024-04-10 | No | No | Historical |
| 70518-4048-2 | 70518404802 | 30 TABLET in 1 BOTTLE, PLASTIC (70518-4048-2) | 30 tablet | 2024-09-04 | No | No | Historical |