Xolair PFS
- Product NDC
- 50242-214
- 11-digit product format
- 502420214
- Labeler code
- 50242
- Product ID
- 50242-214_e633fdb6-7fbc-4072-93ed-4e30abc6c3a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- omalizumab
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Genentech, Inc.
- Application
- BLA103976
- Marketing category
- BLA
- Marketing start
- 2018-09-28
- Substance
- OMALIZUMAB
- Active strength
- 75 mg/.5mL
- Pharmacologic classes
- Anti-IgE [EPC], Decreased IgE Activity [PE], IgE-directed Antibody Interactions [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Xolair PFS
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OMALIZUMAB | 75 mg/.5mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 2P471X1Z11 |
| Rxcui | 1657209, 1657212, 2058943, 2058946, 2058949, 2058950, 2663917, 2663918, 2663920, 2663923, 2673760, 2673761, 2673762, 2673763 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ecba0c95-af31-4e39-991d-3814ccdaeba6 | Product name | 1 | 20190103 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 1681bc73-b05f-12c3-1075-382ae39f449c | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50242-214-01 | Xolair PFS | 0.5 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 0.5 | 31 | |
| 50242-214-01 | Xolair PFS | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 31 | |
| 50242-214-03 | Xolair PFS | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 31 | |
| 50242-214-03 | Xolair PFS | 0.5 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 0.5 | 31 | |
| 50242-214-55 | Xolair PFS | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 31 | |
| 50242-214-55 | Xolair PFS | 0.5 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 0.5 | 31 | |
| 50242-214-83 | Xolair PFS | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 31 | |
| 50242-214-83 | Xolair PFS | 0.5 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 0.5 | 31 | |
| 50242-214-86 | Xolair PFS | 0.5 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 0.5 | 31 | |
| 50242-214-86 | Xolair PFS | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 31 | |
| 50242-214-99 | Xolair PFS | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 31 | |
| 50242-214-99 | Xolair PFS | 0.5 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 0.5 | 31 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50242-214-01 | ML - Milliliter | 50242-214 | b187d10b-1cc9-49a5-b0f9-1eaeb81bc34e | 1 | 2018-12-13 |
| 50242-214-03 | ML - Milliliter | 50242-214 | 9ad1d600-5ece-416b-bee3-f549d428129a | 1 | 2025-03-04 |
| 50242-214-55 | ML - Milliliter | 50242-214 | 00dc146f-ecdd-47b8-9c8e-1f83c5bee085 | 1 | 2024-02-14 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| OMALIZUMAB | ACTIVE INGREDIENT | 2P471X1Z11 | XOLAIR (OMALIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.] | 5 | |
| OMALIZUMAB | ACTIVE MOIETY | 2P471X1Z11 | XOLAIR (OMALIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.] | 5 | |
| HISTIDINE | INACTIVE INGREDIENT | 4QD397987E | XOLAIR (OMALIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.] | 5 | |
| HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE | INACTIVE INGREDIENT | X573657P6P | XOLAIR (OMALIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.] | 5 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | XOLAIR (OMALIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.] | 5 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | XOLAIR (OMALIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.] | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50242-214 | XOLAIR (OMALIZUMAB) INJECTION, SOLUTION XOLAIR PFS (OMALIZUMAB) INJECTION, SOLUTION XOLAIR (OMALIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.] | 28 | Current NDC, Legacy NDC, 12 package rows | 20241123_7f6a2191-adfb-48b9-9bfa-0d9920479f0d.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2673760 | omalizumab 150 MG in 1 ML Auto-Injector | PSN | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2058943 | omalizumab 150 MG in 1 ML Prefilled Syringe | PSN | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 1657209 | omalizumab 150 MG Injection | PSN | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2663920 | omalizumab 300 MG in 2 ML Auto-Injector | PSN | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2663917 | omalizumab 300 MG in 2 ML Prefilled Syringe | PSN | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2673762 | omalizumab 75 MG in 0.5 ML Auto-Injector | PSN | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2058949 | omalizumab 75 MG in 0.5 ML Prefilled Syringe | PSN | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2673761 | Xolair 150 MG in 1 ML Auto-Injector | PSN | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2058946 | Xolair 150 MG in 1 ML Prefilled Syringe | PSN | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 1657212 | Xolair 150 MG Injection | PSN | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2663923 | Xolair 300 MG in 2 ML Auto-Injector | PSN | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2663918 | Xolair 300 MG in 2 ML Prefilled Syringe | PSN | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2673763 | Xolair 75 MG in 0.5 ML Auto-Injector | PSN | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2058950 | Xolair 75 MG in 0.5 ML Prefilled Syringe | PSN | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2673763 | 0.5 ML omalizumab 150 MG/ML Auto-Injector [Xolair] | SBD | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2058950 | 0.5 ML omalizumab 150 MG/ML Prefilled Syringe [Xolair] | SBD | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2673761 | 1 ML omalizumab 150 MG/ML Auto-Injector [Xolair] | SBD | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2058946 | 1 ML omalizumab 150 MG/ML Prefilled Syringe [Xolair] | SBD | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2663923 | 2 ML omalizumab 150 MG/ML Auto-Injector [Xolair] | SBD | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2663918 | 2 ML omalizumab 150 MG/ML Prefilled Syringe [Xolair] | SBD | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 1657212 | omalizumab 150 MG Injection [Xolair] | SBD | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2673762 | 0.5 ML omalizumab 150 MG/ML Auto-Injector | SCD | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2058949 | 0.5 ML omalizumab 150 MG/ML Prefilled Syringe | SCD | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2673760 | 1 ML omalizumab 150 MG/ML Auto-Injector | SCD | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2058943 | 1 ML omalizumab 150 MG/ML Prefilled Syringe | SCD | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2663920 | 2 ML omalizumab 150 MG/ML Auto-Injector | SCD | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2663917 | 2 ML omalizumab 150 MG/ML Prefilled Syringe | SCD | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 1657209 | omalizumab 150 MG Injection | SCD | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2058950 | 0.5 ML Xolair 150 MG/ML Prefilled Syringe | SY | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2058946 | 1 ML Xolair 150 MG/ML Prefilled Syringe | SY | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2673760 | omalizumab 150 MG per 1 ML Auto-Injector | SY | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2058943 | omalizumab 150 MG per 1 ML Prefilled Syringe | SY | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2663920 | omalizumab 300 MG per 2 ML Auto-Injector | SY | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2663917 | omalizumab 300 MG per 2 ML Prefilled Syringe | SY | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2673762 | omalizumab 75 MG per 0.5 ML Auto-Injector | SY | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2058949 | omalizumab 75 MG per 0.5 ML Prefilled Syringe | SY | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 1657212 | Xolair 150 MG Injection | SY | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2673761 | Xolair 150 MG per 1 ML Auto-Injector | SY | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2058946 | Xolair 150 MG per 1 ML Prefilled Syringe | SY | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2663923 | Xolair 300 MG per 2 ML Auto-Injector | SY | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2663918 | Xolair 300 MG per 2 ML Prefilled Syringe | SY | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2673763 | Xolair 75 MG per 0.5 ML Auto-Injector | SY | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
| 2058950 | Xolair 75 MG per 0.5 ML Prefilled Syringe | SY | 7f6a2191-adfb-48b9-9bfa-0d9920479f0d | 31 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50242-214-01 | 50242021401 | 1 SYRINGE, GLASS in 1 CARTON (50242-214-01) / .5 mL in 1 SYRINGE, GLASS | 2018-09-28 | 0000-00-00 | No | No | Current |
| 50242-214-03 | 50242021403 | 1 SYRINGE, GLASS in 1 CARTON (50242-214-03) / .5 mL in 1 SYRINGE, GLASS | 2023-08-18 | No | No | Historical | |
| 50242-214-55 | 50242021455 | 1 SYRINGE, GLASS in 1 CARTON (50242-214-55) / .5 mL in 1 SYRINGE, GLASS | 2023-08-18 | No | No | Historical | |
| 50242-214-83 | 50242021483 | 1 SYRINGE, GLASS in 1 CARTON (50242-214-83) / .5 mL in 1 SYRINGE, GLASS | 2023-08-18 | Yes | No | Historical | |
| 50242-214-86 | 50242021486 | 1 SYRINGE, GLASS in 1 CARTON (50242-214-86) / .5 mL in 1 SYRINGE, GLASS | 2018-09-28 | 0000-00-00 | Yes | No | Current |
| 50242-214-99 | 50242021499 | 1 SYRINGE, GLASS in 1 CARTON (50242-214-99) / .5 mL in 1 SYRINGE, GLASS | 2023-08-18 | Yes | No | Historical |