Imlygic
- Product NDC
- 55513-079
- 11-digit product format
- 555130079
- Labeler code
- 55513
- Product ID
- 55513-079_4d1843a8-7a83-4062-ba8c-4f97e2f1427b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- talimogene laherparepvec
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRALESIONAL
- Labeler
- Amgen Inc
- Application
- BLA125518
- Marketing category
- BLA
- Marketing start
- 2015-11-02
- Substance
- TALIMOGENE LAHERPAREPVEC
- Active strength
- 100000000 [PFU]/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Imlygic
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TALIMOGENE LAHERPAREPVEC | 100000000 [PFU]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 07730V90L6 |
| Rxcui | 1721278, 1721283, 1721287, 1721289 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55513-079-01 | Imlygic | 1 mL in 1 VIAL | INJECTION, SUSPENSION | 1 | | 27 |
| 55513-079-01 | Imlygic | 1 in 1 CARTON | INJECTION, SUSPENSION | 1 | | 27 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TALIMOGENE LAHERPAREPVEC | ACTIVE INGREDIENT | 07730V90L6 | IMLYGIC (TALIMOGENE LAHERPAREPVEC) INJECTION, SUSPENSION [AMGEN INC] | 4 | |
| TALIMOGENE LAHERPAREPVEC | ACTIVE MOIETY | 07730V90L6 | IMLYGIC (TALIMOGENE LAHERPAREPVEC) INJECTION, SUSPENSION [AMGEN INC] | 4 | |
| INOSITOL | INACTIVE INGREDIENT | 4L6452S749 | IMLYGIC (TALIMOGENE LAHERPAREPVEC) INJECTION, SUSPENSION [AMGEN INC] | 4 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | IMLYGIC (TALIMOGENE LAHERPAREPVEC) INJECTION, SUSPENSION [AMGEN INC] | 4 | |
| SODIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | 94255I6E2T | IMLYGIC (TALIMOGENE LAHERPAREPVEC) INJECTION, SUSPENSION [AMGEN INC] | 4 | |
| SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | INACTIVE INGREDIENT | 5QWK665956 | IMLYGIC (TALIMOGENE LAHERPAREPVEC) INJECTION, SUSPENSION [AMGEN INC] | 4 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | IMLYGIC (TALIMOGENE LAHERPAREPVEC) INJECTION, SUSPENSION [AMGEN INC] | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | IMLYGIC (TALIMOGENE LAHERPAREPVEC) INJECTION, SUSPENSION [AMGEN INC] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55513-079 | IMLYGIC (TALIMOGENE LAHERPAREPVEC) INJECTION, SUSPENSION [AMGEN INC] | 27 | Current NDC, Legacy NDC, 2 package rows | 20250418_64ffb680-ea8c-42fc-9649-9e8c0eb77ddb.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 1721283 | IMLYGIC 1,000,000 PFU in 1 mL Injection | PSN | 64ffb680-ea8c-42fc-9649-9e8c0eb77ddb | 27 |
| 1721289 | IMLYGIC 100,000,000 PFU in 1 mL Injection | PSN | 64ffb680-ea8c-42fc-9649-9e8c0eb77ddb | 27 |
| 1721278 | talimogene laherparepvec 1,000,000 PFU in 1 mL Injection | PSN | 64ffb680-ea8c-42fc-9649-9e8c0eb77ddb | 27 |
| 1721287 | talimogene laherparepvec 100,000,000 PFU in 1 mL Injection | PSN | 64ffb680-ea8c-42fc-9649-9e8c0eb77ddb | 27 |
| 1721283 | 1 ML talimogene laherparepvec 1000000 UNT/ML Injection [Imlygic] | SBD | 64ffb680-ea8c-42fc-9649-9e8c0eb77ddb | 27 |
| 1721289 | 1 ML talimogene laherparepvec 100000000 UNT/ML Injection [Imlygic] | SBD | 64ffb680-ea8c-42fc-9649-9e8c0eb77ddb | 27 |
| 1721278 | 1 ML talimogene laherparepvec 1000000 UNT/ML Injection | SCD | 64ffb680-ea8c-42fc-9649-9e8c0eb77ddb | 27 |
| 1721287 | 1 ML talimogene laherparepvec 100000000 UNT/ML Injection | SCD | 64ffb680-ea8c-42fc-9649-9e8c0eb77ddb | 27 |
| 1721283 | 1 ML Imlygic 1000000 UNT/ML Injection | SY | 64ffb680-ea8c-42fc-9649-9e8c0eb77ddb | 27 |
| 1721289 | 1 ML Imlygic 100000000 UNT/ML Injection | SY | 64ffb680-ea8c-42fc-9649-9e8c0eb77ddb | 27 |
| 1721283 | Imlygic 1,000,000 PFU per 1 ML Injection | SY | 64ffb680-ea8c-42fc-9649-9e8c0eb77ddb | 27 |
| 1721289 | Imlygic 100,000,000 PFU per 1 ML Injection | SY | 64ffb680-ea8c-42fc-9649-9e8c0eb77ddb | 27 |
| 1721278 | talimogene laherparepvec 1,000,000 PFU per 1 ML Injection | SY | 64ffb680-ea8c-42fc-9649-9e8c0eb77ddb | 27 |
| 1721287 | talimogene laherparepvec 100,000,000 PFU per 1 ML Injection | SY | 64ffb680-ea8c-42fc-9649-9e8c0eb77ddb | 27 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55513-079-01 | 55513007901 | 1 VIAL in 1 CARTON (55513-079-01) / 1 mL in 1 VIAL | 1 vial | 2015-11-02 | 0000-00-00 | No | No | Current |