Amitriptyline Hydrochloride
- Product NDC
- 71335-9710
- 11-digit product format
- 713359710
- Labeler code
- 71335
- Product ID
- 71335-9710_e127fb06-d8b0-4db9-9fb5-8db4849b9ba6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA213999
- Marketing category
- ANDA
- Marketing start
- 2021-02-23
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 150 mg/1
- Pharmacologic classes
- Tricyclic Antidepressant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amitriptyline Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMITRIPTYLINE HYDROCHLORIDE | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 26LUD4JO9K |
| Rxcui | 856773 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-9710-1 | Amitriptyline Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 101 |
| 71335-9710-2 | Amitriptyline Hydrochloride | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 101 |
| 71335-9710-3 | Amitriptyline Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 101 |
| 71335-9710-4 | Amitriptyline Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 101 |
| 71335-9710-5 | Amitriptyline Hydrochloride | 18 in 1 BOTTLE | TABLET, FILM COATED | 18 | | 101 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-9710 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 100 | Current NDC, 5 package rows | 20230526_9f9d6495-47ff-4dcf-9643-ebd5cd7499cb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-9710-1 | 71335971001 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-9710-1) | 2026-04-10 | No | No | Historical |
| 71335-9710-2 | 71335971002 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-9710-2) | 2026-04-10 | No | No | Historical |
| 71335-9710-3 | 71335971003 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-9710-3) | 2023-06-06 | No | No | Historical |
| 71335-9710-4 | 71335971004 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-9710-4) | 2026-04-10 | No | No | Historical |
| 71335-9710-5 | 71335971005 | 18 TABLET, FILM COATED in 1 BOTTLE (71335-9710-5) | 2026-04-10 | No | No | Historical |