Protriptyline Hydrochloride
- Product NDC
- 42794-007
- 11-digit product format
- 427940007
- Labeler code
- 42794
- Product ID
- 42794-007_f1f190da-554e-55cb-e053-2a95a90a2871
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Protriptyline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sigmapharm Laboratories, LLC
- Application
- ANDA090462
- Marketing category
- ANDA
- Marketing start
- 2020-03-02
- Substance
- PROTRIPTYLINE HYDROCHLORIDE
- Active strength
- 10 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
- Protriptyline Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PROTRIPTYLINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 44665V00O8 |
| Rxcui | 905168, 905172 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42794-007-02 | Protriptyline Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42794-007 | PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SIGMAPHARM LABORATORIES, LLC] | 2 | Current NDC, Legacy NDC, 1 package rows | 20230111_a023e637-bee9-8c86-e053-2a95a90aa488.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42794-007-02 | 42794000702 | 100 TABLET, FILM COATED in 1 BOTTLE (42794-007-02) | 2020-03-02 | 0000-00-00 | No | No | Current |