KEYTRUDA
- Product NDC
- 0006-3026
- 11-digit product format
- 000063026
- Labeler code
- 0006
- Product ID
- 0006-3026_2251fde0-831a-4f47-a325-0859f3a235e7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pembrolizumab
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Merck Sharp & Dohme LLC
- Application
- BLA125514
- Marketing category
- BLA
- Marketing start
- 2015-01-15
- Substance
- PEMBROLIZUMAB
- Active strength
- 25 mg/mL
- Pharmacologic classes
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- KEYTRUDA
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PEMBROLIZUMAB | 25 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | DPT0O3T46P |
| Rxcui | 1657746, 1657749, 1657750, 1657751 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0006-3026-01 | KEYTRUDA | 4 mL in 1 VIAL | INJECTION, SOLUTION | 4 | | 225 |
| 0006-3026-02 | KEYTRUDA | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 225 |
| 0006-3026-04 | KEYTRUDA | 2 in 1 CARTON | INJECTION, SOLUTION | 2 | | 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 |
|---|
| 0006-3026 | KEYTRUDA (PEMBROLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION KEYTRUDA (PEMBROLIZUMAB) INJECTION, SOLUTION [MERCK SHARP & DOHME LLC ] | 207 | Current NDC, Legacy NDC, 3 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 | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0006-3026-01 | 00006302601 | 4 mL in 1 VIAL | 4 ml | | | | | Historical |
| 0006-3026-02 | 00006302602 | 1 VIAL in 1 CARTON (0006-3026-02) / 4 mL in 1 VIAL (0006-3026-01) | 1 vial | 2015-01-15 | 0000-00-00 | No | No | Current |
| 0006-3026-04 | 00006302604 | 2 VIAL in 1 CARTON (0006-3026-04) / 4 mL in 1 VIAL (0006-3026-01) | 2 vial | 2019-08-01 | 0000-00-00 | No | No | Current |