Amitriptyline Hydrochloride
- Product NDC
- 0781-1491
- 11-digit product format
- 007811491
- Labeler code
- 0781
- Product ID
- 0781-1491_9df45420-7268-454e-9624-8da48c97b7db
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sandoz Inc
- Application
- ANDA085968
- Marketing category
- ANDA
- Marketing start
- 1977-11-21
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 150 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 |
|---|---|
| AMITRIPTYLINE HYDROCHLORIDE | 150 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 26LUD4JO9K |
| Rxcui | 856762, 856773, 856783, 856834, 856845, 856853 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e5006e90-7f2e-4341-bcdb-f83027a8fc39 | Product name | 6 | 20240611 |
| 6f1277d7-db3a-63fa-be84-d390d1482706 | Product name | 1 | 20140508 |
| aa9828b2-adf8-0dd3-9f6c-b68f39e467c1 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0781-1491-01 | 2020-08-18 | C162847 | 48780-1 | ab0e2407-2711-f274-e053-dbdaa90a6471 | Amitriptyline Hydrochloride Tablets, USP |
| 0781-1491-10 | 2020-08-18 | C162847 | 48780-1 | ab0e2407-2711-f274-e053-dbdaa90a6471 | Amitriptyline Hydrochloride Tablets, USP |
| 0781-1491-31 | 2020-08-18 | C162847 | 48780-1 | ab0e2407-2711-f274-e053-dbdaa90a6471 | Amitriptyline Hydrochloride Tablets, USP |
| 0781-1491-01 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-2711-f274-e053-dbdaa90a6471 | Amitriptyline Hydrochloride Tablets, USP |
| 0781-1491-10 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-2711-f274-e053-dbdaa90a6471 | Amitriptyline Hydrochloride Tablets, USP |
| 0781-1491-31 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-2711-f274-e053-dbdaa90a6471 | Amitriptyline Hydrochloride Tablets, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0781-1491-01 | Amitriptyline Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 27 | |
| 0781-1491-10 | Amitriptyline Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 27 | |
| 0781-1491-31 | Amitriptyline Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 27 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 856783 | amitriptyline HCl 10 MG Oral Tablet | PSN | 705a2bae-031d-4218-82fe-4346542c0baa | 27 |
| 856762 | amitriptyline HCl 100 MG Oral Tablet | PSN | 705a2bae-031d-4218-82fe-4346542c0baa | 27 |
| 856773 | amitriptyline HCl 150 MG Oral Tablet | PSN | 705a2bae-031d-4218-82fe-4346542c0baa | 27 |
| 856834 | amitriptyline HCl 25 MG Oral Tablet | PSN | 705a2bae-031d-4218-82fe-4346542c0baa | 27 |
| 856845 | amitriptyline HCl 50 MG Oral Tablet | PSN | 705a2bae-031d-4218-82fe-4346542c0baa | 27 |
| 856853 | amitriptyline HCl 75 MG Oral Tablet | PSN | 705a2bae-031d-4218-82fe-4346542c0baa | 27 |
| 856783 | amitriptyline hydrochloride 10 MG Oral Tablet | SCD | 705a2bae-031d-4218-82fe-4346542c0baa | 27 |
| 856762 | amitriptyline hydrochloride 100 MG Oral Tablet | SCD | 705a2bae-031d-4218-82fe-4346542c0baa | 27 |
| 856773 | amitriptyline hydrochloride 150 MG Oral Tablet | SCD | 705a2bae-031d-4218-82fe-4346542c0baa | 27 |
| 856834 | amitriptyline hydrochloride 25 MG Oral Tablet | SCD | 705a2bae-031d-4218-82fe-4346542c0baa | 27 |
| 856845 | amitriptyline hydrochloride 50 MG Oral Tablet | SCD | 705a2bae-031d-4218-82fe-4346542c0baa | 27 |
| 856853 | amitriptyline hydrochloride 75 MG Oral Tablet | SCD | 705a2bae-031d-4218-82fe-4346542c0baa | 27 |
| 856783 | amitriptyline HCl 10 MG Oral Tablet | PSN | 8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c | 2 |
| 856762 | amitriptyline HCl 100 MG Oral Tablet | PSN | 8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c | 2 |
| 856773 | amitriptyline HCl 150 MG Oral Tablet | PSN | 8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c | 2 |
| 856834 | amitriptyline HCl 25 MG Oral Tablet | PSN | 8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c | 2 |
| 856845 | amitriptyline HCl 50 MG Oral Tablet | PSN | 8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c | 2 |
| 856853 | amitriptyline HCl 75 MG Oral Tablet | PSN | 8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c | 2 |
| 856783 | amitriptyline hydrochloride 10 MG Oral Tablet | SCD | 8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c | 2 |
| 856762 | amitriptyline hydrochloride 100 MG Oral Tablet | SCD | 8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c | 2 |
| 856773 | amitriptyline hydrochloride 150 MG Oral Tablet | SCD | 8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c | 2 |
| 856834 | amitriptyline hydrochloride 25 MG Oral Tablet | SCD | 8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c | 2 |
| 856845 | amitriptyline hydrochloride 50 MG Oral Tablet | SCD | 8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c | 2 |
| 856853 | amitriptyline hydrochloride 75 MG Oral Tablet | SCD | 8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0781-1491-01 | 00781149101 | 100 TABLET, FILM COATED in 1 BOTTLE (0781-1491-01) | 1977-11-21 | 0000-00-00 | No | No | Current |
| 0781-1491-10 | 00781149110 | 1000 in 1 BOTTLE | Historical | ||||
| 0781-1491-31 | 00781149131 | 30 in 1 BOTTLE | Historical |