Amitriptyline Hydrochloride
- Product NDC
- 70756-201
- 11-digit product format
- 707560201
- Labeler code
- 70756
- Product ID
- 70756-201_2595d2ab-fd5d-462c-82d4-656d20aa9415
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Lifestar Pharma LLC
- Application
- ANDA213999
- Marketing category
- ANDA
- Marketing start
- 2021-02-23
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Tricyclic Antidepressant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amitriptyline Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMITRIPTYLINE HYDROCHLORIDE | 10 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 |
|---|
| 70756-201-11 | Amitriptyline Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 9 |
| 70756-201-12 | Amitriptyline Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70756-201 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [LIFESTAR PHARMA LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20250410_67e31675-1da2-4acf-84ac-77522b02f0b9.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 |
|---|
| 70756-201-11 | 70756020111 | 100 TABLET, FILM COATED in 1 BOTTLE (70756-201-11) | 2021-02-23 | 0000-00-00 | No | No | Current |
| 70756-201-12 | 70756020112 | 1000 TABLET, FILM COATED in 1 BOTTLE (70756-201-12) | 2021-02-23 | 0000-00-00 | No | No | Current |