LAMPIT
- Product NDC
- 50419-750
- 11-digit product format
- 504190750
- Labeler code
- 50419
- Product ID
- 50419-750_9b14492a-5ae2-4d0a-85c0-212636daf8cd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nifurtimox
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bayer HealthCare Pharmaceuticals Inc.
- Application
- NDA213464
- Marketing category
- NDA
- Marketing start
- 2020-10-01
- Substance
- NIFURTIMOX
- Active strength
- 30 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LAMPIT
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NIFURTIMOX | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | M84I3K7C2O |
| Rxcui | 430512, 2395842, 2397991, 2397994 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50419-750-01 | LAMPIT | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 9 |
| 50419-750-01 | LAMPIT | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50419-750 | LAMPIT (NIFURTIMOX) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20241211_90d09714-a8b1-4696-8ada-f99dc54d0721.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 |
|---|
| 50419-750-01 | 50419075001 | 1 BOTTLE in 1 CARTON (50419-750-01) / 100 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2020-10-01 | 0000-00-00 | No | No | Current |