Mixed Vespid Hymenoptera Venom
- Product NDC
- 65044-9955
- 11-digit product format
- 650449955
- Labeler code
- 65044
- Product ID
- 65044-9955_d9dbd973-178d-4953-83db-defd300258ba
- Type
- STANDARDIZED ALLERGENIC
- Nonproprietary name
- Mixed Vespid Hymenoptera Venom Multidose
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Jubilant HollisterStier LLC
- Application
- BLA103883
- Marketing category
- BLA
- Marketing start
- 1995-04-11
- Substance
- DOLICHOVESPULA ARENARIA VENOM PROTEIN; DOLICHOVESPULA MACULATA VENOM PROTEIN; VESPULA GERMANICA VENOM PROTEIN; VESPULA MACULIFRONS VENOM PROTEIN; VESPULA PENSYLVANICA VENOM PROTEIN; VESPULA SQUAMOSA VENOM PROTEIN; VESPULA VULGARIS VENOM PROTEIN
- Active strength
- 100; 100; 20; 20; 20; 20; 20 ug/mL; ug/mL; ug/mL; ug/mL; ug/mL; ug/mL; ug/mL
- Pharmacologic classes
- Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC], Standardized Insect Venom Allergenic Extract [EPC], Standardized Insect Venom Allergenic Extract [EPC], Standardized Insect Venom Allergenic Extract [EPC], Standardized Insect Venom Allergenic Extract [EPC], Standardized Insect Venom Allergenic Extract [EPC], Standardized Insect Venom Allergenic Extract [EPC], Wasp Venoms [CS], Wasp Venoms [CS], Wasp Venoms [CS], Wasp Venoms [CS], Wasp Venoms [CS], Wasp Venoms [CS], Wasp Venoms [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mixed Vespid Hymenoptera Venom
- Brand name suffix
- Multidose
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DOLICHOVESPULA ARENARIA VENOM PROTEIN | 100 ug/mL |
| DOLICHOVESPULA MACULATA VENOM PROTEIN | 100 ug/mL |
| VESPULA GERMANICA VENOM PROTEIN | 20 ug/mL |
| VESPULA MACULIFRONS VENOM PROTEIN | 20 ug/mL |
| VESPULA PENSYLVANICA VENOM PROTEIN | 20 ug/mL |
| VESPULA SQUAMOSA VENOM PROTEIN | 20 ug/mL |
| VESPULA VULGARIS VENOM PROTEIN | 20 ug/mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65044-9955-6 | Mixed Vespid Hymenoptera VenomMultidose | 13 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 13 | 19 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 65044-9955 | HONEY BEE HYMENOPTERA VENOM MULTIDOSE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION WHITE FACED HORNET HYMENOPTERA VENOM MULTIDOSE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION WASP HYMENOPTERA VENOM MULTIDOSE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION YELLOW JACKET HYMENOPTERA VENOM MULTIDOSE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION MIXED VESPID HYMENOPTERA VENOM MULTIDOSE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JUBILANT HOLLISTERSTIER LLC] | 17 | Current NDC, Legacy NDC, 1 package rows | 20241103_9aeb05aa-6de7-433a-9476-180fa8cba467.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1297542 | bald-faced hornet venom protein 0.1 MG/mL / common wasp venom protein 0.02 MG/mL / eastern yellow jacket venom protein 0.02 MG/mL / German wasp venom protein 0.02 MG/mL / southern yellow jacket venom protein 0.02 MG/mL / western yellow jacket venom protein 0.02 MG/mL / yellow hornet venom protein 0.1 MG/mL Injectable Solution | PSN | 9aeb05aa-6de7-433a-9476-180fa8cba467 | 19 |
| 1297562 | bald-faced hornet venom protein 0.1 MG/mL Injectable Solution | PSN | 9aeb05aa-6de7-433a-9476-180fa8cba467 | 19 |
| 1294639 | common paper wasp venom protein 0.025 MG/mL / metricus paper wasp venom protein 0.025 MG/mL / northern paper wasp venom protein 0.025 MG/mL / red paper wasp venom protein 0.025 MG/mL Injectable Solution | PSN | 9aeb05aa-6de7-433a-9476-180fa8cba467 | 19 |
| 1297582 | common wasp venom protein 0.02 MG/mL / eastern yellow jacket venom protein 0.02 MG/mL / German wasp venom protein 0.02 MG/mL / southern yellow jacket venom protein 0.02 MG/mL / western yellow jacket venom protein 0.02 MG/mL Injectable Solution | PSN | 9aeb05aa-6de7-433a-9476-180fa8cba467 | 19 |
| 854166 | European honey bee venom protein 0.1 MG/mL Injectable Solution | PSN | 9aeb05aa-6de7-433a-9476-180fa8cba467 | 19 |
| 1297542 | bald-faced hornet venom protein 0.1 MG/ML / common wasp venom protein 0.02 MG/ML / eastern yellow jacket venom protein 0.02 MG/ML / German wasp venom protein 0.02 MG/ML / southern yellow jacket venom protein 0.02 MG/ML / western yellow jacket venom protein 0.02 MG/ML / yellow hornet venom protein 0.1 MG/ML Injectable Solution | SCD | 9aeb05aa-6de7-433a-9476-180fa8cba467 | 19 |
| 1297562 | bald-faced hornet venom protein 0.1 MG/ML Injectable Solution | SCD | 9aeb05aa-6de7-433a-9476-180fa8cba467 | 19 |
| 1294639 | common paper wasp venom protein 0.025 MG/ML / metricus paper wasp venom protein 0.025 MG/ML / northern paper wasp venom protein 0.025 MG/ML / red paper wasp venom protein 0.025 MG/ML Injectable Solution | SCD | 9aeb05aa-6de7-433a-9476-180fa8cba467 | 19 |
| 1297582 | common wasp venom protein 0.02 MG/ML / eastern yellow jacket venom protein 0.02 MG/ML / German wasp venom protein 0.02 MG/ML / southern yellow jacket venom protein 0.02 MG/ML / western yellow jacket venom protein 0.02 MG/ML Injectable Solution | SCD | 9aeb05aa-6de7-433a-9476-180fa8cba467 | 19 |
| 854166 | European honey bee venom protein 0.1 MG/ML Injectable Solution | SCD | 9aeb05aa-6de7-433a-9476-180fa8cba467 | 19 |
| 854166 | Apis mellifera venom protein 100 MCG/ML Injectable Solution | SY | 9aeb05aa-6de7-433a-9476-180fa8cba467 | 19 |
| 1297562 | bald-faced hornet venom protein 100 MCG/ML Injectable Solution | SY | 9aeb05aa-6de7-433a-9476-180fa8cba467 | 19 |
| 1297542 | Dolichovespula maculata venom protein 100 MCG / Vespula vulgaris venom protein 20 MCG / Vespula maculifrons venom protein 20 MCG / Vespula germanica venom protein 20 MCG / Vespula squamosa venom protein 20 MCG / Vespula pensylvanica venom 20 MCG / Dolichovespula arenaria venom protein 100 MCG per 1 ML Powder for Injectable Solution | SY | 9aeb05aa-6de7-433a-9476-180fa8cba467 | 19 |
| 1297562 | Dolichovespula maculata venom protein 120 MCG per 1.2 ML Powder for Injectable Solution | SY | 9aeb05aa-6de7-433a-9476-180fa8cba467 | 19 |
| 1294639 | Polistes exclamans venom protein 0.025 MG/ML / Polistes metricus venom protein 0.025 MG/ML / Polistes fuscatus venom protein 25 MCG / Polistes annularis venom protein 0.025 MG/ML Powder for Injectable Solution | SY | 9aeb05aa-6de7-433a-9476-180fa8cba467 | 19 |
| 1294639 | Polistes exclamans venom protein 25 MCG / Polistes metricus venom protein 25 MCG / Polistes fuscatus venom protein 25 MCG / Polistes annularis venom protein 25 MCG per 1 ML Powder for Injectable Solution | SY | 9aeb05aa-6de7-433a-9476-180fa8cba467 | 19 |
| 1297582 | Vespula vulgaris venom protein 20 MCG / Vespula maculifrons venom protein 20 MCG / Vespula germanica venom protein 20 MCG / Vespula squamosa venom protein 20 MCG / Vespula pensylvanica venom protein 20 MCG per ML Powder for Injectable Solution | SY | 9aeb05aa-6de7-433a-9476-180fa8cba467 | 19 |
| 854166 | western honey bee venom protein 0.1 MG/ML Injectable Solution | SY | 9aeb05aa-6de7-433a-9476-180fa8cba467 | 19 |
| 1297562 | white faced hornet venom protein 0.1 MG/ML Injectable Solution | SY | 9aeb05aa-6de7-433a-9476-180fa8cba467 | 19 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 65044-9955-6 | 65044995506 | 13 mL in 1 VIAL (65044-9955-6) | 13 ml | 1995-04-11 | 0000-00-00 | No | No | Current |