KEYTRUDA
- Product NDC
- 0006-3029
- 11-digit product format
- 000063029
- Labeler code
- 0006
- Product ID
- 0006-3029_dc05a1ee-eea1-4f08-b201-a8e6f97cde13
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pembrolizumab
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Merck Sharp & Dohme Corp.
- Application
- BLA125514
- Marketing category
- BLA
- Marketing start
- 2014-09-04
- Marketing end
- 0000-00-00
- Substance
- PEMBROLIZUMAB
- Active strength
- 50 mg/2mL
- Pharmacologic classes
- Programmed Death Receptor-1 Blocking Antibody [EPC],Programmed Death Receptor-1-directed Antibody Interactions [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0006-3029-01 | KEYTRUDA | 15 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 15 | | 225 |
| 0006-3029-02 | KEYTRUDA | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 225 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| pembrolizumab | ACTIVE INGREDIENT | DPT0O3T46P | KEYTRUDA (PEMBROLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION KEYTRUDA (PEMBROLIZUMAB) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.] | 9 | |
| pembrolizumab | ACTIVE MOIETY | DPT0O3T46P | KEYTRUDA (PEMBROLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION KEYTRUDA (PEMBROLIZUMAB) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.] | 9 | |
| HISTIDINE | INACTIVE INGREDIENT | 4QD397987E | KEYTRUDA (PEMBROLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION KEYTRUDA (PEMBROLIZUMAB) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.] | 9 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | KEYTRUDA (PEMBROLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION KEYTRUDA (PEMBROLIZUMAB) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.] | 9 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | KEYTRUDA (PEMBROLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION KEYTRUDA (PEMBROLIZUMAB) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.] | 9 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | KEYTRUDA (PEMBROLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION KEYTRUDA (PEMBROLIZUMAB) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.] | 9 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | KEYTRUDA (PEMBROLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION KEYTRUDA (PEMBROLIZUMAB) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.] | 9 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | KEYTRUDA (PEMBROLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION KEYTRUDA (PEMBROLIZUMAB) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.] | 9 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0006-3029 | KEYTRUDA (PEMBROLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION KEYTRUDA (PEMBROLIZUMAB) INJECTION, SOLUTION [MERCK SHARP & DOHME LLC ] | 207 | Legacy NDC, 2 package rows | 20250430_9333c79b-d487-4538-a9f0-71b91a02b287.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 0006-3029-01 | 00006302901 | 15 mL in 1 VIAL | 15 ml | Historical |
| 0006-3029-02 | 00006302902 | 1 in 1 CARTON | | Historical |