Amitriptyline Hydrochloride
- Product NDC
- 71335-2374
- 11-digit product format
- 713352374
- Labeler code
- 71335
- Product ID
- 71335-2374_3a62a016-ae4b-4c92-aa9f-eb4f097e2c6c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA217411
- Marketing category
- ANDA
- Marketing start
- 2023-06-10
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Tricyclic Antidepressant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 71335-2374_3a62a016-ae4b-4c92-aa9f-eb4f097e2c6c
- SPL ID
- 3a62a016-ae4b-4c92-aa9f-eb4f097e2c6c
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Amitriptyline Hydrochloride
- Generic name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2023-06-10
- Marketing category
- ANDA
- Application number
- ANDA217411
- Pharmacologic classes
- Tricyclic Antidepressant [EPC]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| AMITRIPTYLINE HYDROCHLORIDE | 100 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 26LUD4JO9K |
| Rxcui | 856762 |
| Spl Set Id | c707a873-6b67-478f-aa3c-d206a59cbe6d |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71335-2374-1 | 30 TABLET in 1 BOTTLE (71335-2374-1) | 2024-05-29 | No |
| 71335-2374-2 | 60 TABLET in 1 BOTTLE (71335-2374-2) | 2024-05-29 | No |
| 71335-2374-3 | 90 TABLET in 1 BOTTLE (71335-2374-3) | 2024-05-29 | No |
| 71335-2374-4 | 180 TABLET in 1 BOTTLE (71335-2374-4) | 2024-05-29 | No |
| 71335-2374-5 | 28 TABLET in 1 BOTTLE (71335-2374-5) | 2024-05-29 | No |
| 71335-2374-6 | 120 TABLET in 1 BOTTLE (71335-2374-6) | 2024-05-29 | No |
| 71335-2374-7 | 18 TABLET in 1 BOTTLE (71335-2374-7) | 2024-05-29 | No |
| 71335-2374-8 | 8 TABLET in 1 BOTTLE (71335-2374-8) | 2024-05-29 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 26LUD4JO9K | AMITRIPTYLINE HYDROCHLORIDE | 549-18-8 | AMITRIPTYLINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2374-1 | 71335237401 | 30 TABLET in 1 BOTTLE (71335-2374-1) | 30 tablet | 2024-05-29 | No | No | Historical |
| 71335-2374-2 | 71335237402 | 60 TABLET in 1 BOTTLE (71335-2374-2) | 60 tablet | 2024-05-29 | No | No | Historical |
| 71335-2374-3 | 71335237403 | 90 TABLET in 1 BOTTLE (71335-2374-3) | 90 tablet | 2024-05-29 | No | No | Historical |
| 71335-2374-4 | 71335237404 | 180 TABLET in 1 BOTTLE (71335-2374-4) | 180 tablet | 2024-05-29 | No | No | Historical |
| 71335-2374-5 | 71335237405 | 28 TABLET in 1 BOTTLE (71335-2374-5) | 28 tablet | 2024-05-29 | No | No | Historical |
| 71335-2374-6 | 71335237406 | 120 TABLET in 1 BOTTLE (71335-2374-6) | 120 tablet | 2024-05-29 | No | No | Historical |
| 71335-2374-7 | 71335237407 | 18 TABLET in 1 BOTTLE (71335-2374-7) | 18 tablet | 2024-05-29 | No | No | Historical |
| 71335-2374-8 | 71335237408 | 8 TABLET in 1 BOTTLE (71335-2374-8) | 8 tablet | 2024-05-29 | No | No | Historical |