iwilfin
- Product NDC
- 78670-150
- 11-digit product format
- 786700150
- Labeler code
- 78670
- Product ID
- 78670-150_5b900700-64d3-4f68-834a-2a71f5216a46
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- EFLORNITHINE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- USWM, LLC
- Application
- NDA215500
- Marketing category
- NDA
- Marketing start
- 2024-01-15
- Substance
- EFLORNITHINE HYDROCHLORIDE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Antiprotozoal [EPC], Decarboxylase Inhibitor [EPC], Decarboxylase 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
- iwilfin
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EFLORNITHINE HYDROCHLORIDE | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4NH22NDW9H |
| Rxcui | 2673199, 2673205 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 78670-150-01 | iwilfin | 100 in 1 BOTTLE | TABLET | 100 | | 7 |
| 78670-150-01 | iwilfin | 1 in 1 CARTON | TABLET | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 78670-150 | IWILFIN (EFLORNITHINE HYDROCHLORIDE) TABLET [USWM, LLC] | 5 | Current NDC, 2 package rows | 20250326_6716d8cc-66e6-4cee-935c-ccb85ed984f5.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 |
|---|
| 78670-150-01 | 78670015001 | 1 BOTTLE in 1 CARTON (78670-150-01) / 100 TABLET in 1 BOTTLE | 1 bottle | 2024-01-15 | No | No | Current |