Amitriptyline Hydrochloride
- Product NDC
- 71610-711
- 11-digit product format
- 716100711
- Labeler code
- 71610
- Product ID
- 71610-711_ee8718a4-d803-4a58-9c87-06987c7dd356
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA089399
- Marketing category
- ANDA
- Marketing start
- 1987-07-14
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 50 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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 26LUD4JO9K |
| Rxcui | 856783, 856834, 856845 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-711-29 | Amitriptyline Hydrochloride | 29 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 29 | | 7 |
| 71610-711-30 | Amitriptyline Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 7 |
| 71610-711-60 | Amitriptyline Hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-711 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 7 | Current NDC, 3 package rows | 20230916_4e0f3b15-3621-48a1-9f2b-b0a373920360.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-711-29 | 71610071129 | 29 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-711-29) | 2023-09-15 | No | No | Historical |
| 71610-711-30 | 71610071130 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-711-30) | 2023-05-31 | No | No | Historical |
| 71610-711-60 | 71610071160 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-711-60) | 2023-06-29 | No | No | Historical |