Amitriptyline Hydrochloride
- Product NDC
- 11788-078
- 11-digit product format
- 117880078
- Labeler code
- 11788
- Product ID
- 11788-078_4ee04ba3-df06-44c2-8476-09b6cd38f863
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AiPing Pharmaceutical, Inc.
- Application
- ANDA212654
- Marketing category
- ANDA
- Marketing start
- 2025-11-01
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 25 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 | 25 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11788-078-01 | Amitriptyline Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | 3 | |
| 11788-078-10 | Amitriptyline Hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 11788-078-01 | EA - Each | 11788-078 | 1b53811a-600d-4b12-ac33-129f634b00f1 | 1 | 2026-01-08 |
| 11788-078-10 | EA - Each | 11788-078 | 05ba998f-fd53-4113-9ebd-585852d646cc | 1 | 2026-01-08 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 856783 | amitriptyline HCl 10 MG Oral Tablet | PSN | 33807ee6-8443-4613-8bbe-d66f6010fc60 | 3 |
| 856762 | amitriptyline HCl 100 MG Oral Tablet | PSN | 33807ee6-8443-4613-8bbe-d66f6010fc60 | 3 |
| 856773 | amitriptyline HCl 150 MG Oral Tablet | PSN | 33807ee6-8443-4613-8bbe-d66f6010fc60 | 3 |
| 856834 | amitriptyline HCl 25 MG Oral Tablet | PSN | 33807ee6-8443-4613-8bbe-d66f6010fc60 | 3 |
| 856845 | amitriptyline HCl 50 MG Oral Tablet | PSN | 33807ee6-8443-4613-8bbe-d66f6010fc60 | 3 |
| 856853 | amitriptyline HCl 75 MG Oral Tablet | PSN | 33807ee6-8443-4613-8bbe-d66f6010fc60 | 3 |
| 856783 | amitriptyline hydrochloride 10 MG Oral Tablet | SCD | 33807ee6-8443-4613-8bbe-d66f6010fc60 | 3 |
| 856762 | amitriptyline hydrochloride 100 MG Oral Tablet | SCD | 33807ee6-8443-4613-8bbe-d66f6010fc60 | 3 |
| 856773 | amitriptyline hydrochloride 150 MG Oral Tablet | SCD | 33807ee6-8443-4613-8bbe-d66f6010fc60 | 3 |
| 856834 | amitriptyline hydrochloride 25 MG Oral Tablet | SCD | 33807ee6-8443-4613-8bbe-d66f6010fc60 | 3 |
| 856845 | amitriptyline hydrochloride 50 MG Oral Tablet | SCD | 33807ee6-8443-4613-8bbe-d66f6010fc60 | 3 |
| 856853 | amitriptyline hydrochloride 75 MG Oral Tablet | SCD | 33807ee6-8443-4613-8bbe-d66f6010fc60 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 11788-078-01 | 11788007801 | 100 TABLET in 1 BOTTLE (11788-078-01) | 100 tablet | 2025-11-01 | No | No | Historical |
| 11788-078-10 | 11788007810 | 1000 TABLET in 1 BOTTLE (11788-078-10) | 1000 tablet | 2025-11-01 | No | No | Historical |