INPEFA
- Product NDC
- 70183-241
- 11-digit product format
- 701830241
- Labeler code
- 70183
- Product ID
- 70183-241_cd790640-aade-49e0-a549-6eac00d3efc2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sotagliflozin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lexicon Pharmaceuticals, Inc.
- Application
- NDA216203
- Marketing category
- NDA
- Marketing start
- 2023-05-26
- Substance
- SOTAGLIFLOZIN
- Active strength
- 400 mg/1
- Pharmacologic classes
- P-Glycoprotein Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- INPEFA
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SOTAGLIFLOZIN | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6B4ZBS263Y |
| Rxcui | 2638683, 2638689, 2638691, 2638693 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70183-241-30 | INPEFA | 30 in 1 BOTTLE | TABLET | 30 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70183-241 | INPEFA (SOTAGLIFLOZIN) TABLET [LEXICON PHARMACEUTICALS, INC.] | 9 | Current NDC, 1 package rows | 20240130_1a46614e-05f6-421a-b6f4-d6f8760d643a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70183-241-30 | 70183024130 | 30 TABLET in 1 BOTTLE (70183-241-30) | 30 tablet | 2023-12-01 | No | No | Current |