AMITRIPTYLINE HYDROCHLORIDE
- Product NDC
- 63187-637
- 11-digit product format
- 631870637
- Labeler code
- 63187
- Product ID
- 63187-637_503fd66a-220b-410b-b82f-2c449dbb8dab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMITRIPTYLINE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA202446
- Marketing category
- ANDA
- Marketing start
- 2014-12-05
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 10 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 | 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 |
|---|
| 63187-637-30 | AMITRIPTYLINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
| 63187-637-60 | AMITRIPTYLINE HYDROCHLORIDE | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 5 |
| 63187-637-90 | AMITRIPTYLINE HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-637 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] | 5 | Current NDC, Legacy NDC, 3 package rows | 20220513_df5aee40-ffa9-4cf3-ab5f-30253f43092b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63187-637-30 | 63187063730 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-637-30) | 2018-12-01 | 0000-00-00 | No | No | Current |
| 63187-637-60 | 63187063760 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-637-60) | 2018-12-01 | 0000-00-00 | No | No | Current |
| 63187-637-90 | 63187063790 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-637-90) | 2018-12-01 | 0000-00-00 | No | No | Current |