Gattex
- Product NDC
- 68875-0101
- 11-digit product format
- 688750101
- Labeler code
- 68875
- Product ID
- 68875-0101_20ca0019-d3a4-4a8f-8dd4-67179d06e4dc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- teduglutide
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Takeda Pharmaceuticals America, Inc.
- Application
- NDA203441
- Marketing category
- NDA
- Marketing start
- 2012-12-21
- Substance
- TEDUGLUTIDE
- Active strength
- 5 mg/.5mL
- Pharmacologic classes
- Analogs/Derivatives [Chemical/Ingredient], GLP-2 Analog [EPC], Glucagon-Like Peptide 2 [Chemical/Ingredient], Glucagon-like Peptide-2 (GLP-2) Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Gattex
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TEDUGLUTIDE | 5 mg/.5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7M19191IKG |
| Rxcui | 1364472, 1364477, 1489307 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68875-0101-1 | Gattex | 0.5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 0.5 mL | 5 mg in 0.5mL | 20 |
| 68875-0101-1 | Gattex | 0.5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 15 mL | 5 mg in 0.5mL | 20 |
| 68875-0101-1 | Gattex | 0.5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 0.5 | | 20 |
| 68875-0101-2 | Gattex | 30 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 30 | | 20 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| teduglutide | ACTIVE INGREDIENT | 7M19191IKG | GATTEX (TEDUGLUTIDE) INJECTION, POWDER, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [NPS PHARMACEUTICALS] | 3 | |
| water | ACTIVE INGREDIENT | 059QF0KO0R | GATTEX (TEDUGLUTIDE) INJECTION, POWDER, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [NPS PHARMACEUTICALS] | 3 | |
| teduglutide | ACTIVE MOIETY | 7M19191IKG | GATTEX (TEDUGLUTIDE) INJECTION, POWDER, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [NPS PHARMACEUTICALS] | 3 | |
| water | ACTIVE MOIETY | 059QF0KO0R | GATTEX (TEDUGLUTIDE) INJECTION, POWDER, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [NPS PHARMACEUTICALS] | 3 | |
| Histidine | INACTIVE INGREDIENT | 4QD397987E | GATTEX (TEDUGLUTIDE) INJECTION, POWDER, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [NPS PHARMACEUTICALS] | 3 | |
| mannitol | INACTIVE INGREDIENT | 3OWL53L36A | GATTEX (TEDUGLUTIDE) INJECTION, POWDER, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [NPS PHARMACEUTICALS] | 3 | |
| sodium phosphate, dibasic, heptahydrate | INACTIVE INGREDIENT | 70WT22SF4B | GATTEX (TEDUGLUTIDE) INJECTION, POWDER, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [NPS PHARMACEUTICALS] | 3 | |
| sodium phosphate, monobasic, monohydrate | INACTIVE INGREDIENT | 593YOG76RN | GATTEX (TEDUGLUTIDE) INJECTION, POWDER, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [NPS PHARMACEUTICALS] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68875-0101 | GATTEX (TEDUGLUTIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION GATTEX (TEDUGLUTIDE) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 19 | Current NDC, Legacy NDC, 2 package rows | 20241003_66b69c1e-b25c-44d3-b5ff-1c1de9a516fa.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 |
|---|
| 68875-0101-1 | 68875010101 | 0.5 mL in 1 VIAL | 0.5 ml | | | | | Historical |
| 68875-0101-2 | 68875010102 | 30 VIAL in 1 CARTON (68875-0101-2) / .5 mL in 1 VIAL (68875-0101-1) | 30 vial | 2012-12-21 | 0000-00-00 | No | No | Current |