Amitriptyline Hydrochloride
- Product NDC
- 60687-433
- 11-digit product format
- 606870433
- Labeler code
- 60687
- Product ID
- 60687-433_44706732-5523-8018-e063-6294a90a9cc7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA210086
- Marketing category
- ANDA
- Marketing start
- 2019-08-15
- 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, 856845 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60687-433-01 | Amitriptyline Hydrochloride | 100 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 100 | | 7 |
| 60687-433-11 | Amitriptyline Hydrochloride | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60687-433 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240926_98cc0bf3-ae5b-47cc-992f-9157fed7c3f4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 60687-433-01 | 60687043301 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-433-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-433-11) | 100 blister pack | 2019-08-15 | 0000-00-00 | No | No | Current |
| 60687-433-11 | 60687043311 | 1 in 1 BLISTER PACK | | | | | | Historical |