Amitriptyline Hydrochloride
- Product NDC
- 70518-4330
- 11-digit product format
- 705184330
- Labeler code
- 70518
- Product ID
- 70518-4330_40300c18-032d-bcaf-e063-6294a90af7a8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA212654
- Marketing category
- ANDA
- Marketing start
- 2025-04-16
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 25 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 | 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 |
|---|
| 70518-4330-0 | Amitriptyline Hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET, COATED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4330 | AMITRIPTYLINE HYDROCHLORIDE TABLET, COATED [REMEDYREPACK INC.] | 1 | Current NDC, 1 package rows | 20250418_c072c1b3-ed8a-4f1e-ba6c-580a2b2c8f58.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4330-0 | 70518433000 | 90 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-4330-0) | 2025-04-16 | No | No | Historical |