ERWINASE
- Product NDC
- 81561-413
- 11-digit product format
- 815610413
- Labeler code
- 81561
- Product ID
- 81561-413_10bba7af-957c-4cc6-ba44-5569fca4f885
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- asparaginase
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Porton Biopharma Limited
- Marketing category
- UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
- Marketing start
- 2021-06-01
- Marketing end
- 0000-00-00
- Substance
- ASPARAGINASE ERWINIA CHRYSANTHEMI
- Active strength
- 10000 [iU]/mL
- Pharmacologic classes
- Asparaginase [CS],Asparagine-specific Enzyme [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 81561-413-01 | ERWINASE | 1 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
| 81561-413-05 | ERWINASE | 5 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 5 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81561-413 | ERWINASE (ASPARAGINASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PORTON BIOPHARMA LIMITED] | 2 | Legacy NDC, 2 package rows | 20210616_bd0f5322-a1d3-79c3-e053-2995a90acd70.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 |
|---|
| 81561-413-01 | 81561041301 | 1 mL in 1 VIAL, GLASS | 1 ml | | | | | Historical |
| 81561-413-05 | 81561041305 | 5 VIAL, GLASS in 1 CARTON (81561-413-05) > 1 mL in 1 VIAL, GLASS (81561-413-01) | | 2021-06-01 | 0000-00-00 | No | No | Current |