Protriptyline Hydrochloride
- Product NDC
- 42806-097
- 11-digit product format
- 428060097
- Labeler code
- 42806
- Product ID
- 42806-097_e68d74c7-1d6a-4453-bb46-0047047b7527
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Protriptyline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Epic Pharma, LLC
- Application
- ANDA202220
- Marketing category
- ANDA
- Marketing start
- 2013-01-09
- 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 |
|---|
| 42806-097-01 | Protriptyline Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 10 |
| 42806-097-10 | Protriptyline Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 10 |
| 42806-097-30 | Protriptyline Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PROTRIPTYLINE HYDROCHLORIDE | ACTIVE INGREDIENT | 44665V00O8 | PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 5 | |
| PROTRIPTYLINE | ACTIVE MOIETY | 4NDU154T12 | PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 5 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 5 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 5 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 5 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 5 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 5 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 5 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 5 | |
| STARCH, POTATO | INACTIVE INGREDIENT | 8I089SAH3T | PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 5 | |
| STARCH, TAPIOCA | INACTIVE INGREDIENT | 24SC3U704I | PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 5 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42806-097 | PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 10 | Current NDC, Legacy NDC, 3 package rows | 20231221_c6c7c39e-e510-4f4a-bf7a-926f0e075d3a.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 |
|---|
| 42806-097-01 | 42806009701 | 100 TABLET, FILM COATED in 1 BOTTLE (42806-097-01) | 2013-01-09 | 0000-00-00 | No | No | Current |
| 42806-097-10 | 42806009710 | 1000 TABLET, FILM COATED in 1 BOTTLE (42806-097-10) | 2013-01-09 | 0000-00-00 | No | No | Current |
| 42806-097-30 | 42806009730 | 30 TABLET, FILM COATED in 1 BOTTLE (42806-097-30) | 2020-07-10 | 0000-00-00 | No | No | Current |