TEZSPIRE
- Product NDC
- 55513-100
- 11-digit product format
- 555130100
- Labeler code
- 55513
- Product ID
- 55513-100_25a4a901-927c-4f3a-a1c4-72826d46e946
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tezepelumab-ekko
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Amgen, Inc
- Application
- BLA761224
- Marketing category
- BLA
- Marketing start
- 2021-12-17
- Marketing end
- 0000-00-00
- Substance
- TEZEPELUMAB
- Active strength
- 210 mg/1.9mL
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dcda8adb-29c0-4f01-aff6-2e9233ef700d | Product name | 1 | 20220720 |
| 48747306-602a-42cc-957b-5b0c69158eee | Product name | 1 | 20180604 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55513-100-01 | TEZSPIRE | 1.91 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 1.91 | 15 | |
| 55513-100-01 | TEZSPIRE | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 15 | |
| 55513-100-96 | TEZSPIRE | 1.91 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 1.91 | 15 | |
| 55513-100-96 | TEZSPIRE | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 15 | |
| 55513-100-99 | TEZSPIRE | 1.91 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 1.91 | 15 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2628920 | tezepelumab-ekko 210 MG in 1.91 ML Auto-Injector | PSN | 60f0aa03-ad25-4d48-80ce-7fcfa76f325f | 15 |
| 2587794 | tezepelumab-ekko 210 MG in 1.91 ML Injection | PSN | 60f0aa03-ad25-4d48-80ce-7fcfa76f325f | 15 |
| 2587803 | tezepelumab-ekko 210 MG in 1.91 ML Prefilled Syringe | PSN | 60f0aa03-ad25-4d48-80ce-7fcfa76f325f | 15 |
| 2628923 | Tezspire 210 MG in 1.91 ML Auto-Injector | PSN | 60f0aa03-ad25-4d48-80ce-7fcfa76f325f | 15 |
| 2587800 | Tezspire 210 MG in 1.91 ML Injection | PSN | 60f0aa03-ad25-4d48-80ce-7fcfa76f325f | 15 |
| 2587806 | Tezspire 210 MG in 1.91 ML Prefilled Syringe | PSN | 60f0aa03-ad25-4d48-80ce-7fcfa76f325f | 15 |
| 2628923 | 1.91 ML tezepelumab-ekko 110 MG/ML Auto-Injector [Tezspire] | SBD | 60f0aa03-ad25-4d48-80ce-7fcfa76f325f | 15 |
| 2587800 | 1.91 ML tezepelumab-ekko 110 MG/ML Injection [Tezspire] | SBD | 60f0aa03-ad25-4d48-80ce-7fcfa76f325f | 15 |
| 2587806 | 1.91 ML tezepelumab-ekko 110 MG/ML Prefilled Syringe [Tezspire] | SBD | 60f0aa03-ad25-4d48-80ce-7fcfa76f325f | 15 |
| 2628920 | 1.91 ML tezepelumab-ekko 110 MG/ML Auto-Injector | SCD | 60f0aa03-ad25-4d48-80ce-7fcfa76f325f | 15 |
| 2587794 | 1.91 ML tezepelumab-ekko 110 MG/ML Injection | SCD | 60f0aa03-ad25-4d48-80ce-7fcfa76f325f | 15 |
| 2587803 | 1.91 ML tezepelumab-ekko 110 MG/ML Prefilled Syringe | SCD | 60f0aa03-ad25-4d48-80ce-7fcfa76f325f | 15 |
| 2628923 | 1.91 ML Tezspire 110 MG/ML Auto-Injector | SY | 60f0aa03-ad25-4d48-80ce-7fcfa76f325f | 15 |
| 2587800 | 1.91 ML Tezspire 110 MG/ML Injection | SY | 60f0aa03-ad25-4d48-80ce-7fcfa76f325f | 15 |
| 2587806 | 1.91 ML Tezspire 110 MG/ML Prefilled Syringe | SY | 60f0aa03-ad25-4d48-80ce-7fcfa76f325f | 15 |
| 2628920 | tezepelumab-ekko 210 MG per 1.91 ML Auto-Injector | SY | 60f0aa03-ad25-4d48-80ce-7fcfa76f325f | 15 |
| 2587794 | tezepelumab-ekko 210 MG per 1.91 ML Injection | SY | 60f0aa03-ad25-4d48-80ce-7fcfa76f325f | 15 |
| 2587803 | tezepelumab-ekko 210 MG per 1.91 ML Prefilled Syringe | SY | 60f0aa03-ad25-4d48-80ce-7fcfa76f325f | 15 |
| 2628923 | Tezspire 210 MG per 1.91 ML Auto-Injector | SY | 60f0aa03-ad25-4d48-80ce-7fcfa76f325f | 15 |
| 2587800 | Tezspire 210 MG per 1.91 ML Injection | SY | 60f0aa03-ad25-4d48-80ce-7fcfa76f325f | 15 |
| 2587806 | Tezspire 210 MG per 1.91 ML Prefilled Syringe | SY | 60f0aa03-ad25-4d48-80ce-7fcfa76f325f | 15 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55513-100-01 | 55513010001 | 1 VIAL, GLASS in 1 CARTON (55513-100-01) > 1.91 mL in 1 VIAL, GLASS | 2021-12-17 | 0000-00-00 | No | No | Current | |
| 55513-100-96 | 55513010096 | 1 VIAL, GLASS in 1 CARTON (55513-100-96) > 1.91 mL in 1 VIAL, GLASS | 2021-12-17 | 0000-00-00 | Yes | No | Current | |
| 55513-100-99 | 55513010099 | 1.91 mL in 1 VIAL, GLASS (55513-100-99) | 1.91 ml | 2021-12-17 | 0000-00-00 | Yes | No | Current |