AMITRIPTYLINE HYDROCHLORIDE
- Product NDC
- 50090-2553
- 11-digit product format
- 500902553
- Labeler code
- 50090
- Product ID
- 50090-2553_0e6d3575-3408-448c-a577-972d345c42df
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMITRIPTYLINE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA202446
- Marketing category
- ANDA
- Marketing start
- 2014-12-05
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-2553-0 | 2023-02-07 | C162847 | 48780-1 | f386c649-f867-0266-e053-dadaa90a7c1a | bc78f035-08ce-4a5a-b51f-03384a2c157a |
| 50090-2553-1 | 2023-02-07 | C162847 | 48780-1 | f386c649-f867-0266-e053-dadaa90a7c1a | bc78f035-08ce-4a5a-b51f-03384a2c157a |
| 50090-2553-2 | 2023-02-07 | C162847 | 48780-1 | f386c649-f867-0266-e053-dadaa90a7c1a | bc78f035-08ce-4a5a-b51f-03384a2c157a |
| 50090-2553-5 | 2023-02-07 | C162847 | 48780-1 | f386c649-f867-0266-e053-dadaa90a7c1a | bc78f035-08ce-4a5a-b51f-03384a2c157a |
| 50090-2553-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-f867-0266-e053-dadaa90a7c1a | bc78f035-08ce-4a5a-b51f-03384a2c157a |
| 50090-2553-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-f867-0266-e053-dadaa90a7c1a | bc78f035-08ce-4a5a-b51f-03384a2c157a |
| 50090-2553-2 | 2023-01-30 | C162847 | 48780-1 | f386c649-f867-0266-e053-dadaa90a7c1a | bc78f035-08ce-4a5a-b51f-03384a2c157a |
| 50090-2553-5 | 2023-01-30 | C162847 | 48780-1 | f386c649-f867-0266-e053-dadaa90a7c1a | bc78f035-08ce-4a5a-b51f-03384a2c157a |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-2553-0 | EA - Each | 50090-2553 | f12ce6fd-9b9a-4bb5-9062-00f0c21ebd1c | 1 | 2019-03-12 |
| 50090-2553-1 | EA - Each | 50090-2553 | becee21a-d788-4341-95d3-6f5cdb812dba | 1 | 2019-03-12 |
| 50090-2553-2 | EA - Each | 50090-2553 | 10d2eb28-8239-42d5-a287-1c5fb35bc73f | 1 | 2019-03-12 |
| 50090-2553-5 | EA - Each | 50090-2553 | f58f5b3e-43e5-493e-a128-9d294fa4dbab | 1 | 2019-03-12 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50090-2553-0 | 50090255300 | 100 TABLET, FILM COATED in 1 BOTTLE (50090-2553-0) | 2018-08-09 | 0000-00-00 | No | No | Current |
| 50090-2553-1 | 50090255301 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-2553-1) | 2016-12-16 | 0000-00-00 | No | No | Current |
| 50090-2553-2 | 50090255302 | 60 TABLET, FILM COATED in 1 BOTTLE (50090-2553-2) | 2018-07-27 | 0000-00-00 | No | No | Current |
| 50090-2553-5 | 50090255305 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-2553-5) | 2018-08-30 | 0000-00-00 | No | No | Current |