Sincalide
- Product NDC
- 70511-131
- 11-digit product format
- 705110131
- Labeler code
- 70511
- Product ID
- 70511-131_f79a9ced-87d3-4e83-af8c-1451fcec4520
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sincalide
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- MAIA Pharmaceuticals, Inc.
- Application
- NDA210850
- Marketing category
- NDA
- Marketing start
- 2022-11-25
- Substance
- SINCALIDE
- Active strength
- 5 ug/5mL
- Pharmacologic classes
- Cholecystokinin Analog [EPC], Cholecystokinin [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sincalide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SINCALIDE | 5 ug/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | M03GIQ7Z6P |
| Rxcui | 237982 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70511-131-05 | Sincalide | 5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 | | 4 |
| 70511-131-84 | Sincalide | 10 in 1 PACKAGE | INJECTION, POWDER, LYOPHILIZED, | 10 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70511-131 | SINCALIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MAIA PHARMACEUTICALS, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20231102_4149af34-7b3d-4200-9609-ea856b1d6aab.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 |
|---|
| 70511-131-05 | 70511013105 | 5 mL in 1 VIAL | 5 ml | | | | | Historical |
| 70511-131-84 | 70511013184 | 10 VIAL in 1 PACKAGE (70511-131-84) / 5 mL in 1 VIAL (70511-131-05) | 10 vial | 2022-11-25 | 0000-00-00 | No | No | Current |