Penpulimab
- Product NDC
- 83654-105
- 11-digit product format
- 836540105
- Labeler code
- 83654
- Product ID
- 83654-105_3392cd59-0d45-e081-e063-6394a90a0353
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Penpulimab
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Akeso Biopharma, Co., Ltd
- Application
- BLA761258
- Marketing category
- BLA
- Marketing start
- 2025-04-23
- Substance
- PENPULIMAB
- Active strength
- 100 mg/10mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Penpulimab
- Brand name suffix
- kcqx
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PENPULIMAB | 100 mg/10mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | IBS1BZ4E4I |
| Rxcui | 2712652 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83654-105-01 | Penpulimabkcqx | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 | | 1 |
| 83654-105-01 | Penpulimabkcqx | 1 in 1 BOX | INJECTION | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83654-105 | PENPULIMAB KCQX (PENPULIMAB) INJECTION [AKESO BIOPHARMA, CO., LTD] | 1 | Current NDC, 2 package rows | 20250430_830004e8-31af-4cc6-ab16-e870cab1c5ca.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 83654-105-01 | 83654010501 | 1 VIAL, SINGLE-DOSE in 1 BOX (83654-105-01) / 10 mL in 1 VIAL, SINGLE-DOSE | 2025-04-23 | Yes | No | Historical |