Amitriptyline Hydrochloride
- Product NDC
- 70710-1226
- 11-digit product format
- 707101226
- Labeler code
- 70710
- Product ID
- 70710-1226_5160111f-8889-4057-aa2a-519eccd14a5e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA210086
- Marketing category
- ANDA
- Marketing start
- 2017-12-26
- 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 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 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 |
|---|---|---|---|---|---|---|
| 70710-1226-0 | Amitriptyline Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 5 | |
| 70710-1226-1 | Amitriptyline Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70710-1226-0 | EA - Each | 70710-1226 | 2aca371b-f2cc-4e2f-b9af-978e4923b837 | 1 | 2018-07-03 |
| 70710-1226-1 | EA - Each | 70710-1226 | 8e4ec6c6-e4a8-4dce-a437-5e520d762fa6 | 1 | 2018-07-03 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70710-1226 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250406_73669354-babc-4687-a4fe-ad0fc1f863ba.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 856834 | amitriptyline HCl 25 MG Oral Tablet | PSN | 0067b698-ee1d-4524-b1cc-af1028d13736 | 10 |
| 856834 | amitriptyline hydrochloride 25 MG Oral Tablet | SCD | 0067b698-ee1d-4524-b1cc-af1028d13736 | 10 |
| 856834 | amitriptyline HCl 25 MG Oral Tablet | PSN | 98cc0bf3-ae5b-47cc-992f-9157fed7c3f4 | 7 |
| 856845 | amitriptyline HCl 50 MG Oral Tablet | PSN | 98cc0bf3-ae5b-47cc-992f-9157fed7c3f4 | 7 |
| 856834 | amitriptyline hydrochloride 25 MG Oral Tablet | SCD | 98cc0bf3-ae5b-47cc-992f-9157fed7c3f4 | 7 |
| 856845 | amitriptyline hydrochloride 50 MG Oral Tablet | SCD | 98cc0bf3-ae5b-47cc-992f-9157fed7c3f4 | 7 |
| 856783 | amitriptyline HCl 10 MG Oral Tablet | PSN | 73669354-babc-4687-a4fe-ad0fc1f863ba | 5 |
| 856762 | amitriptyline HCl 100 MG Oral Tablet | PSN | 73669354-babc-4687-a4fe-ad0fc1f863ba | 5 |
| 856773 | amitriptyline HCl 150 MG Oral Tablet | PSN | 73669354-babc-4687-a4fe-ad0fc1f863ba | 5 |
| 856834 | amitriptyline HCl 25 MG Oral Tablet | PSN | 73669354-babc-4687-a4fe-ad0fc1f863ba | 5 |
| 856845 | amitriptyline HCl 50 MG Oral Tablet | PSN | 73669354-babc-4687-a4fe-ad0fc1f863ba | 5 |
| 856853 | amitriptyline HCl 75 MG Oral Tablet | PSN | 73669354-babc-4687-a4fe-ad0fc1f863ba | 5 |
| 856783 | amitriptyline hydrochloride 10 MG Oral Tablet | SCD | 73669354-babc-4687-a4fe-ad0fc1f863ba | 5 |
| 856762 | amitriptyline hydrochloride 100 MG Oral Tablet | SCD | 73669354-babc-4687-a4fe-ad0fc1f863ba | 5 |
| 856773 | amitriptyline hydrochloride 150 MG Oral Tablet | SCD | 73669354-babc-4687-a4fe-ad0fc1f863ba | 5 |
| 856834 | amitriptyline hydrochloride 25 MG Oral Tablet | SCD | 73669354-babc-4687-a4fe-ad0fc1f863ba | 5 |
| 856845 | amitriptyline hydrochloride 50 MG Oral Tablet | SCD | 73669354-babc-4687-a4fe-ad0fc1f863ba | 5 |
| 856853 | amitriptyline hydrochloride 75 MG Oral Tablet | SCD | 73669354-babc-4687-a4fe-ad0fc1f863ba | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70710-1226-0 | 70710122600 | 1000 TABLET, FILM COATED in 1 BOTTLE (70710-1226-0) | 2017-12-26 | 0000-00-00 | No | No | Current |
| 70710-1226-1 | 70710122601 | 100 TABLET, FILM COATED in 1 BOTTLE (70710-1226-1) | 2017-12-26 | 0000-00-00 | No | No | Current |