Amitriptyline Hydrochloride
- Product NDC
- 71335-3007
- 11-digit product format
- 713353007
- Labeler code
- 71335
- Product ID
- 71335-3007_38ed32d4-0f8d-491c-8c67-7b38d7d72513
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA212654
- Marketing category
- ANDA
- Marketing start
- 2024-05-20
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 26LUD4JO9K |
| Rxcui | 856783 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-3007-0 | Amitriptyline Hydrochloride | 100 in 1 BOTTLE | TABLET, COATED | 100 | | 1 |
| 71335-3007-1 | Amitriptyline Hydrochloride | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 1 |
| 71335-3007-2 | Amitriptyline Hydrochloride | 15 in 1 BOTTLE | TABLET, COATED | 15 | | 1 |
| 71335-3007-3 | Amitriptyline Hydrochloride | 60 in 1 BOTTLE | TABLET, COATED | 60 | | 1 |
| 71335-3007-4 | Amitriptyline Hydrochloride | 90 in 1 BOTTLE | TABLET, COATED | 90 | | 1 |
| 71335-3007-5 | Amitriptyline Hydrochloride | 28 in 1 BOTTLE | TABLET, COATED | 28 | | 1 |
| 71335-3007-6 | Amitriptyline Hydrochloride | 120 in 1 BOTTLE | TABLET, COATED | 120 | | 1 |
| 71335-3007-7 | Amitriptyline Hydrochloride | 50 in 1 BOTTLE | TABLET, COATED | 50 | | 1 |
| 71335-3007-8 | Amitriptyline Hydrochloride | 180 in 1 BOTTLE | TABLET, COATED | 180 | | 1 |
| 71335-3007-9 | Amitriptyline Hydrochloride | 6 in 1 BOTTLE | TABLET, COATED | 6 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-3007-0 | 71335300700 | 100 TABLET, COATED in 1 BOTTLE (71335-3007-0) | 2026-02-04 | No | No | Current |
| 71335-3007-1 | 71335300701 | 30 TABLET, COATED in 1 BOTTLE (71335-3007-1) | 2026-02-04 | No | No | Current |
| 71335-3007-2 | 71335300702 | 15 TABLET, COATED in 1 BOTTLE (71335-3007-2) | 2026-02-04 | No | No | Current |
| 71335-3007-3 | 71335300703 | 60 TABLET, COATED in 1 BOTTLE (71335-3007-3) | 2026-02-04 | No | No | Current |
| 71335-3007-4 | 71335300704 | 90 TABLET, COATED in 1 BOTTLE (71335-3007-4) | 2026-02-04 | No | No | Current |
| 71335-3007-5 | 71335300705 | 28 TABLET, COATED in 1 BOTTLE (71335-3007-5) | 2026-02-04 | No | No | Current |
| 71335-3007-6 | 71335300706 | 120 TABLET, COATED in 1 BOTTLE (71335-3007-6) | 2026-02-04 | No | No | Current |
| 71335-3007-7 | 71335300707 | 50 TABLET, COATED in 1 BOTTLE (71335-3007-7) | 2026-02-04 | No | No | Current |
| 71335-3007-8 | 71335300708 | 180 TABLET, COATED in 1 BOTTLE (71335-3007-8) | 2026-02-04 | No | No | Current |
| 71335-3007-9 | 71335300709 | 6 TABLET, COATED in 1 BOTTLE (71335-3007-9) | 2026-02-04 | No | No | Current |