Panhematin
- Product NDC
- 55292-702
- 11-digit product format
- 552920702
- Labeler code
- 55292
- Product ID
- 55292-702_ff0139fe-eb46-4d22-95f1-849de7ce9462
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hemin
- Dosage form
- POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Recordati Rare Diseases, Inc.
- Application
- BLA101246
- Marketing category
- BLA
- Marketing start
- 1983-07-20
- Substance
- HEMIN
- Active strength
- 7 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Panhematin
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HEMIN | 7 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 743LRP9S7N |
| Rxcui | 1926452, 1926454 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55292-702-54 | Panhematin | 48 mL in 1 VIAL | POWDER, FOR SOLUTION | 48 | | 16 |
| 55292-702-55 | Panhematin | 1 in 1 CARTON | POWDER, FOR SOLUTION | 1 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55292-702 | PANHEMATIN (HEMIN) POWDER, FOR SOLUTION [RECORDATI RARE DISEASES, INC.] | 12 | Current NDC, Legacy NDC, 2 package rows | 20240613_9984267a-4d57-4444-9bb5-16bca7dea691.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 |
|---|
| 55292-702-54 | 55292070254 | 48 mL in 1 VIAL | 48 ml | | | | | Historical |
| 55292-702-55 | 55292070255 | 1 VIAL in 1 CARTON (55292-702-55) / 48 mL in 1 VIAL (55292-702-54) | 1 vial | 1983-07-20 | 0000-00-00 | No | No | Current |