AMITRIPTYLINE HYDROCHLORIDE
- Product NDC
- 68071-4092
- 11-digit product format
- 680714092
- Labeler code
- 68071
- Product ID
- 68071-4092_1d8e1fca-6863-7c08-e063-6394a90a08b6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMITRIPTYLINE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA202446
- Marketing category
- ANDA
- Marketing start
- 2014-12-05
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 26LUD4JO9K |
| Rxcui | 856783 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68071-4092-2 | 2024-07-18 | C162847 | 48780-1 | ba0f9c33-432c-a910-e053-dadaa90a0b85 | Amitriptyline Hydrochloride Tablets, USP |
| 68071-4092-3 | 2024-07-18 | C162847 | 48780-1 | ba0f9c33-432c-a910-e053-dadaa90a0b85 | Amitriptyline Hydrochloride Tablets, USP |
| 68071-4092-6 | 2024-07-18 | C162847 | 48780-1 | ba0f9c33-432c-a910-e053-dadaa90a0b85 | Amitriptyline Hydrochloride Tablets, USP |
| 68071-4092-9 | 2024-07-18 | C162847 | 48780-1 | ba0f9c33-432c-a910-e053-dadaa90a0b85 | Amitriptyline Hydrochloride Tablets, USP |
| 68071-4092-2 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-432c-a910-e053-dadaa90a0b85 | Amitriptyline Hydrochloride Tablets, USP |
| 68071-4092-3 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-432c-a910-e053-dadaa90a0b85 | Amitriptyline Hydrochloride Tablets, USP |
| 68071-4092-6 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-432c-a910-e053-dadaa90a0b85 | Amitriptyline Hydrochloride Tablets, USP |
| 68071-4092-9 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-432c-a910-e053-dadaa90a0b85 | Amitriptyline Hydrochloride Tablets, USP |
| 68071-4092-2 | 2021-02-12 | C162847 | 48780-1 | ba0f9c33-432c-a910-e053-dadaa90a0b85 | Amitriptyline Hydrochloride Tablets, USP |
| 68071-4092-3 | 2021-02-12 | C162847 | 48780-1 | ba0f9c33-432c-a910-e053-dadaa90a0b85 | Amitriptyline Hydrochloride Tablets, USP |
| 68071-4092-6 | 2021-02-12 | C162847 | 48780-1 | ba0f9c33-432c-a910-e053-dadaa90a0b85 | Amitriptyline Hydrochloride Tablets, USP |
| 68071-4092-9 | 2021-02-12 | C162847 | 48780-1 | ba0f9c33-432c-a910-e053-dadaa90a0b85 | Amitriptyline Hydrochloride Tablets, USP |
| 68071-4092-2 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-432c-a910-e053-dadaa90a0b85 | Amitriptyline Hydrochloride Tablets, USP |
| 68071-4092-3 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-432c-a910-e053-dadaa90a0b85 | Amitriptyline Hydrochloride Tablets, USP |
| 68071-4092-6 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-432c-a910-e053-dadaa90a0b85 | Amitriptyline Hydrochloride Tablets, USP |
| 68071-4092-9 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-432c-a910-e053-dadaa90a0b85 | Amitriptyline Hydrochloride Tablets, USP |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-4092-2 | AMITRIPTYLINE HYDROCHLORIDE | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 4 |
| 68071-4092-3 | AMITRIPTYLINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 68071-4092-6 | AMITRIPTYLINE HYDROCHLORIDE | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 4 |
| 68071-4092-9 | AMITRIPTYLINE HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-4092 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] | 4 | Current NDC, Legacy NDC, 4 package rows | 20240720_58ff9a82-5de6-a1b0-e053-2991aa0a84ba.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 |
|---|
| 68071-4092-2 | 68071409202 | 20 TABLET, FILM COATED in 1 BOTTLE (68071-4092-2) | 2017-09-12 | 0000-00-00 | No | No | Current |
| 68071-4092-3 | 68071409203 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-4092-3) | 2017-09-12 | 0000-00-00 | No | No | Current |
| 68071-4092-6 | 68071409206 | 60 TABLET, FILM COATED in 1 BOTTLE (68071-4092-6) | 2017-09-12 | 0000-00-00 | No | No | Current |
| 68071-4092-9 | 68071409209 | 90 TABLET, FILM COATED in 1 BOTTLE (68071-4092-9) | 2017-09-12 | 0000-00-00 | No | No | Current |