Inmazeb
- Product NDC
- 61755-018
- 11-digit product format
- 617550018
- Labeler code
- 61755
- Product ID
- 61755-018_03d5650a-82d9-4af5-9515-ea52c93733ef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- atoltivimab, maftivimab, and odesivimab-ebgn
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Regeneron Pharmaceuticals, Inc.
- Application
- BLA761169
- Marketing category
- BLA
- Marketing start
- 2020-10-14
- Substance
- ATOLTIVIMAB; MAFTIVIMAB; ODESIVIMAB
- Active strength
- 241.7; 241.7; 241.7 mg/14.5mL; mg/14.5mL; mg/14.5mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Inmazeb
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ATOLTIVIMAB | 241.7 mg/14.5mL |
| MAFTIVIMAB | 241.7 mg/14.5mL |
| ODESIVIMAB | 241.7 mg/14.5mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | UY9LQ8P6HW, KOP95331M4, FJZ07Q63VY |
| Rxcui | 2461536, 2461539, 2571682, 2571685 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3c386306-c48a-413e-bb69-70cb268496f3 | Product name | 1 | 20210727 |
| df703147-8958-4375-be27-b042414400aa | Product name | 1 | 20210513 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61755-018-00 | Inmazeb | 14.5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 14.5 | 12 | |
| 61755-018-01 | Inmazeb | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61755-018-01 | ML - Milliliter | 61755-018 | 06019711-cc7b-4311-8517-b2e0c924c76b | 1 | 2025-01-14 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2461536 | atoltivimab-maftivimab-odesivimab-ebgn 241.7 MG / 241.7 MG / 241.7 MG in 14.5 ML Injection | PSN | 0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa | 12 |
| 2571682 | atoltivimab-maftivimab-odesivimab-ebgn 483.3 MG / 483.3 MG / 483.3 MG in 14.5 ML Injection | PSN | 0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa | 12 |
| 2461539 | Inmazeb 241.7 MG / 241.7 MG / 241.7 MG in 14.5 ML Injection | PSN | 0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa | 12 |
| 2571685 | Inmazeb 483.3 MG / 483.3 MG / 483.3 MG in 14.5 ML Injection | PSN | 0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa | 12 |
| 2461539 | 14.5 ML atoltivimab-ebgn 16.7 MG/ML / maftivimab-ebgn 16.7 MG/ML / odesivimab-ebgn 16.7 MG/ML Injection [Inmazeb] | SBD | 0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa | 12 |
| 2571685 | 14.5 ML atoltivimab-ebgn 33.3 MG/ML / maftivimab-ebgn 33.3 MG/ML / odesivimab-ebgn 33.3 MG/ML Injection [Inmazeb] | SBD | 0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa | 12 |
| 2461536 | 14.5 ML atoltivimab-ebgn 16.7 MG/ML / maftivimab-ebgn 16.7 MG/ML / odesivimab-ebgn 16.7 MG/ML Injection | SCD | 0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa | 12 |
| 2571682 | 14.5 ML atoltivimab-ebgn 33.3 MG/ML / maftivimab-ebgn 33.3 MG/ML / odesivimab-ebgn 33.3 MG/ML Injection | SCD | 0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa | 12 |
| 2461536 | atoltivimab-ebgn 16.67 MG/ML / maftivimab-ebgn 16.67 MG/ML / odesivimab-ebgn 16.67 MG/ML per 14.5 ML Injection | SY | 0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa | 12 |
| 2461536 | atoltivimab-ebgn 241.7 MG / maftivimab-ebgn 241.7 MG / odesivimab-ebgn 241.7 MG per 14.5 ML Injection | SY | 0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa | 12 |
| 2571682 | atoltivimab-ebgn 33.33 MG/ML / maftivimab-ebgn 33.33 MG/ML / odesivimab-ebgn 33.33 MG/ML per 14.5 ML Injection | SY | 0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa | 12 |
| 2571682 | atoltivimab-ebgn 483.3 MG / maftivimab-ebgn 483.3 MG / odesivimab-ebgn 483.3 MG per 14.5 ML Injection | SY | 0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa | 12 |
| 2461536 | atoltivimab-maftivimab-odesivimab-ebgn 241.7 MG / 241.7 MG / 241.7 MG per 14.5 ML Injection | SY | 0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa | 12 |
| 2571682 | atoltivimab-maftivimab-odesivimab-ebgn 483.3 MG / 483.3 MG / 483.3 MG per 14.5 ML Injection | SY | 0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa | 12 |
| 2461539 | Inmazeb (atoltivimab-ebgn 16.67 MG/ML / maftivimab-ebgn 16.67 MG/ML / odesivimab-ebgn 16.67 MG/ML) per 14.5 ML Injection | SY | 0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa | 12 |
| 2461539 | Inmazeb (atoltivimab-ebgn 241.7 MG / maftivimab-ebgn 241.7 MG / odesivimab-ebgn 241.7 MG) per 14.5 ML Injection | SY | 0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa | 12 |
| 2571685 | Inmazeb (atoltivimab-ebgn 33.33 MG/ML / maftivimab-ebgn 33.33 MG/ML / odesivimab-ebgn 33.33 MG/ML) per 14.5 ML Injection | SY | 0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa | 12 |
| 2571685 | Inmazeb (atoltivimab-ebgn 483.3 MG / maftivimab-ebgn 483.3 MG / odesivimab-ebgn 483.3 MG) per 14.5 ML Injection | SY | 0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa | 12 |
| 2461539 | Inmazeb 241.7 MG / 241.7 MG / 241.7 MG per 14.5 ML Injection | SY | 0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa | 12 |
| 2571685 | Inmazeb 483.3 MG / 483.3 MG / 483.3 MG per 14.5 ML Injection | SY | 0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61755-018-00 | 61755001800 | 14.5 mL in 1 VIAL, SINGLE-DOSE | 14.5 ml | Historical | ||||
| 61755-018-01 | 61755001801 | 1 VIAL, SINGLE-DOSE in 1 CARTON (61755-018-01) / 14.5 mL in 1 VIAL, SINGLE-DOSE (61755-018-00) | 2020-10-14 | 0000-00-00 | No | No | Current |