Trulance
- Product NDC
- 65649-003
- 11-digit product format
- 656490003
- Labeler code
- 65649
- Product ID
- 65649-003_154842e6-a919-ba71-e063-6394a90aebd4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Plecanatide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Salix Pharmaceuticals Inc.
- Application
- NDA208745
- Marketing category
- NDA
- Marketing start
- 2017-02-21
- Substance
- PLECANATIDE
- Active strength
- 3 mg/1
- Pharmacologic classes
- Guanylate Cyclase Activators [MoA], Guanylate Cyclase-C Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Trulance
- Brand name suffix
- Immediate release
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PLECANATIDE | 3 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7IK8Z952OK |
| Rxcui | 1873757, 1873765 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65649-003-01 | TrulanceImmediate release | 1 in 1 CARTON | TABLET | 1 | | 15 |
| 65649-003-01 | TrulanceImmediate release | 1 in 1 BOTTLE | TABLET | 1 | | 15 |
| 65649-003-03 | TrulanceImmediate release | 1 in 1 CARTON | TABLET | 1 | | 15 |
| 65649-003-03 | TrulanceImmediate release | 3 in 1 BOTTLE | TABLET | 3 | | 15 |
| 65649-003-07 | TrulanceImmediate release | 1 in 1 CARTON | TABLET | 1 | | 15 |
| 65649-003-07 | TrulanceImmediate release | 7 in 1 BOTTLE | TABLET | 7 | | 15 |
| 65649-003-30 | TrulanceImmediate release | 30 in 1 BOTTLE | TABLET | 30 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65649-003 | TRULANCE IMMEDIATE RELEASE (PLECANATIDE) TABLET [SALIX PHARMACEUTICALS INC.] | 15 | Current NDC, Legacy NDC, 7 package rows | 20240405_fe2895bf-71a6-493a-b0ca-e06b2dfefc82.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65649-003-01 | 65649000301 | 1 BOTTLE in 1 CARTON (65649-003-01) / 1 TABLET in 1 BOTTLE | 1 bottle | 2017-02-21 | 0000-00-00 | No | No | Current |
| 65649-003-03 | 65649000303 | 1 BOTTLE in 1 CARTON (65649-003-03) / 3 TABLET in 1 BOTTLE | 1 bottle | 2017-02-21 | 0000-00-00 | No | No | Current |
| 65649-003-07 | 65649000307 | 1 BOTTLE in 1 CARTON (65649-003-07) / 7 TABLET in 1 BOTTLE | 1 bottle | 2017-02-21 | 0000-00-00 | Yes | No | Current |
| 65649-003-30 | 65649000330 | 30 TABLET in 1 BOTTLE (65649-003-30) | 30 tablet | 2017-02-21 | 0000-00-00 | No | No | Current |