KEYTRUDA QLEX
- Product NDC
- 0006-3083
- Requested package NDC
- 0006-3083-01
- 11-digit product format
- 000063083
- Labeler code
- 0006
- Product ID
- 0006-3083_199c024a-6b5f-44ad-839c-83de66a76d6b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pembrolizumab and berahyaluronidase alfa-pmph
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Merck Sharp & Dohme LLC
- Application
- BLA761467
- Marketing category
- BLA
- Marketing start
- 2025-09-19
- Substance
- PEMBROLIZUMAB; BERAHYALURONIDASE ALFA
- Active strength
- 165; 2000 mg/mL; U/mL
- Pharmacologic classes
- Endoglycosidase [EPC], Glycoside Hydrolases [CS], Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- KEYTRUDA QLEX
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PEMBROLIZUMAB | 165 mg/mL |
| BERAHYALURONIDASE ALFA | 2000 U/mL |
Harmonized UNII identifiers#
UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table| Identifier | FDA.report destination |
|---|
| 9X4R4A4HQQ | Internal UNII lookup |
| DPT0O3T46P | Internal UNII lookup |
Harmonized RxCUI identifiers#
RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table| Identifier | FDA.report destination |
|---|
| 2723762 | Internal RxNorm lookup |
| 2723769 | Internal RxNorm lookup |
| 2723771 | Internal RxNorm lookup |
| 2723772 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0006-3083-01 | KEYTRUDA QLEX | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 14 |
| 0006-3083-99 | KEYTRUDA QLEX | 2.4 mL in 1 VIAL | INJECTION, SOLUTION | 2.4 | | 14 |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761467 | Keytruda Qlex | pembrolizumab and berahyaluronidase alfa-pmph | 351(a) | Rx | 2026-10-01 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0006-3083-01 | 00006308301 | 1 VIAL in 1 CARTON (0006-3083-01) / 2.4 mL in 1 VIAL (0006-3083-99) | 1 vial | 2025-09-19 | No | No | Current |