PRE-PEN
- Product NDC
- 49471-001
- 11-digit product format
- 494710001
- Labeler code
- 49471
- Product ID
- 49471-001_630c84ab-994f-4686-99bc-deaf6db7cff2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- benzylpenicilloyl polylysine
- Dosage form
- INJECTION
- Route
- INTRADERMAL; SUBCUTANEOUS
- Labeler
- ALK-ABELLO, INC.
- Application
- BLA050114
- Marketing category
- BLA
- Marketing start
- 1974-07-25
- Substance
- BENZYLPENICILLOYL POLYLYSINE
- Active strength
- 60 umol/.25mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PRE-PEN
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZYLPENICILLOYL POLYLYSINE | 60 umol/.25mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 76479814OY |
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 |
|---|
| 49471-001-05 | PRE-PEN | 0.25 mL in 1 AMPULE | INJECTION | 0.25 | | 5 |
| 49471-001-05 | PRE-PEN | 5 in 1 CARTON | INJECTION | 5 | | 5 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49471-001 | PRE-PEN (BENZYLPENICILLOYL POLYLYSINE) INJECTION [ALLERQUEST LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240415_2fbcc40c-f102-4abe-bce5-a93de95874fe.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 49471-001-05 | 49471000105 | 5 AMPULE in 1 CARTON (49471-001-05) / .25 mL in 1 AMPULE | 5 ampule | 1974-07-25 | 0000-00-00 | No | No | Current |