ELELYSO
- Product NDC
- 0069-0106
- 11-digit product format
- 000690106
- Labeler code
- 0069
- Product ID
- 0069-0106_d7eb51c8-fe18-46f2-8d97-eaa343ec8821
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Taliglucerase alfa
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Pfizer Laboratories Div Pfizer Inc
- Application
- BLA022458
- Marketing category
- BLA
- Marketing start
- 2012-05-01
- Substance
- TALIGLUCERASE ALFA
- Active strength
- 200 U/5mL
- Pharmacologic classes
- Glucosylceramidase [CS], Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ELELYSO
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TALIGLUCERASE ALFA | 200 U/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0R4NLX88O4 |
| Rxcui | 1292879, 1292881 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0069-0106-01 | ELELYSO | 5 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 5 | | 31 |
| 0069-0106-01 | ELELYSO | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 31 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0069-0106 | ELELYSO (TALIGLUCERASE ALFA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] | 30 | Current NDC, Legacy NDC, 2 package rows | 20250129_fa3cbd5d-677c-4b19-9032-d9182cb69a83.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0069-0106-01 | 00069010601 | 1 VIAL, GLASS in 1 CARTON (0069-0106-01) / 5 mL in 1 VIAL, GLASS | 2012-05-01 | 0000-00-00 | No | No | Current |