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
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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 26LUD4JO9K |
| Rxcui | 856762 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-2374-1 | Amitriptyline Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 71335-2374-2 | Amitriptyline Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
| 71335-2374-3 | Amitriptyline Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
| 71335-2374-4 | Amitriptyline Hydrochloride | 180 in 1 BOTTLE | TABLET | 180 | | 1 |
| 71335-2374-5 | Amitriptyline Hydrochloride | 28 in 1 BOTTLE | TABLET | 28 | | 1 |
| 71335-2374-6 | Amitriptyline Hydrochloride | 120 in 1 BOTTLE | TABLET | 120 | | 1 |
| 71335-2374-7 | Amitriptyline Hydrochloride | 18 in 1 BOTTLE | TABLET | 18 | | 1 |
| 71335-2374-8 | Amitriptyline Hydrochloride | 8 in 1 BOTTLE | TABLET | 8 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-2374 | AMITRIPTYLINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 1 | Current NDC, 8 package rows | 20240531_c707a873-6b67-478f-aa3c-d206a59cbe6d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 | Current |
| 71335-2374-2 | 71335237402 | 60 TABLET in 1 BOTTLE (71335-2374-2) | 60 tablet | 2024-05-29 | No | No | Current |
| 71335-2374-3 | 71335237403 | 90 TABLET in 1 BOTTLE (71335-2374-3) | 90 tablet | 2024-05-29 | No | No | Current |
| 71335-2374-4 | 71335237404 | 180 TABLET in 1 BOTTLE (71335-2374-4) | 180 tablet | 2024-05-29 | No | No | Current |
| 71335-2374-5 | 71335237405 | 28 TABLET in 1 BOTTLE (71335-2374-5) | 28 tablet | 2024-05-29 | No | No | Current |
| 71335-2374-6 | 71335237406 | 120 TABLET in 1 BOTTLE (71335-2374-6) | 120 tablet | 2024-05-29 | No | No | Current |
| 71335-2374-7 | 71335237407 | 18 TABLET in 1 BOTTLE (71335-2374-7) | 18 tablet | 2024-05-29 | No | No | Current |
| 71335-2374-8 | 71335237408 | 8 TABLET in 1 BOTTLE (71335-2374-8) | 8 tablet | 2024-05-29 | No | No | Current |