AMITRIPTYLINE HYDROCHLORIDE
- Product NDC
- 53002-3391
- 11-digit product format
- 530023391
- Labeler code
- 53002
- Product ID
- 53002-3391_c445459a-aac6-4215-aab7-75d28486dedd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMITRIPTYLINE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA202446
- Marketing category
- ANDA
- Marketing start
- 2014-12-05
- Marketing end
- 0000-00-00
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Tricyclic Antidepressant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 |
|---|
| 53002-3391-1 | AMITRIPTYLINE HYDROCHLORIDE | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 4 |
| 53002-3391-3 | AMITRIPTYLINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-3391 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.] | 4 | Legacy NDC, 2 package rows | 20220331_0f4a2a75-0d9e-4c36-9b0a-2962c4114a27.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 |
|---|
| 53002-3391-1 | 53002339101 | 10 TABLET, FILM COATED in 1 BOTTLE (53002-3391-1) | 2022-08-01 | 0000-00-00 | No | No | Current |
| 53002-3391-3 | 53002339103 | 30 TABLET, FILM COATED in 1 BOTTLE (53002-3391-3) | 2022-08-01 | 0000-00-00 | No | No | Current |