Amitriptyline Hydrochloride
- Product NDC
- 64330-633
- 11-digit product format
- 643300633
- Labeler code
- 64330
- Product ID
- 64330-633_0a294e70-735e-4226-b52d-9127a1080aa2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Centaur Pharmaceuticals Private Limited
- Application
- ANDA216243
- Marketing category
- ANDA
- Marketing start
- 2022-06-06
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 75 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 | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 26LUD4JO9K |
| Rxcui | 856762, 856773, 856783, 856834, 856845, 856853 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64330-633-01 | Amitriptyline Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64330-633 | AMITRIPTYLINE HYDROCHLORIDE TABLET [CENTAUR PHARMACEUTICALS PRIVATE LIMITED] | 4 | Current NDC, Legacy NDC, 1 package rows | 20220919_3d113e43-c694-427f-8b77-66be36a82374.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 64330-633-01 | 64330063301 | 100 TABLET in 1 BOTTLE (64330-633-01) | 100 tablet | 2022-06-06 | 0000-00-00 | No | No | Current |