Amitriptyline Hydrochloride
- Product NDC
- 43353-164
- 11-digit product format
- 433530164
- Labeler code
- 43353
- Product ID
- 43353-164_c52cd2ff-b891-4423-b147-143dfbe78a11
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA085968
- Marketing category
- ANDA
- Marketing start
- 1977-11-29
- Marketing end
- 0000-00-00
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Tricyclic Antidepressant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43353-164-30 | Amitriptyline Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 43353-164-53 | Amitriptyline Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 4 |
| 43353-164-60 | Amitriptyline Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-164 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 4 | Legacy NDC, 3 package rows | 20191219_cbdca5ce-97c3-4be5-b193-ae07e2ac770d.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 |
|---|
| 43353-164-30 | 43353016430 | 30 TABLET, FILM COATED in 1 BOTTLE (43353-164-30) | 2016-04-11 | 0000-00-00 | No | No | Current |
| 43353-164-53 | 43353016453 | 60 TABLET, FILM COATED in 1 BOTTLE (43353-164-53) | 2016-03-23 | 0000-00-00 | No | No | Current |
| 43353-164-60 | 43353016460 | 90 TABLET, FILM COATED in 1 BOTTLE (43353-164-60) | 2016-04-12 | 0000-00-00 | No | No | Current |