Pollens - Weeds and Garden Plants, Ragweed, Mixed Ambrosia
- Product NDC
- 65044-2315
- 11-digit product format
- 650442315
- Labeler code
- 65044
- Product ID
- 65044-2315_5e6a7a02-f790-4786-96ea-11aa48dfa5d9
- Type
- STANDARDIZED ALLERGENIC
- Nonproprietary name
- Ragweed, Mixed Ambrosia
- Dosage form
- INJECTION, SOLUTION
- Route
- PERCUTANEOUS; SUBCUTANEOUS
- Labeler
- Jubilant HollisterStier LLC
- Application
- BLA103880
- Marketing category
- BLA
- Marketing start
- 1977-10-18
- Substance
- AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN
- Active strength
- .05; .05 g/mL; g/mL
- Pharmacologic classes
- Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pollens - Weeds and Garden Plants, Ragweed, Mixed Ambrosia
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMBROSIA ARTEMISIIFOLIA POLLEN | .05 g/mL |
| AMBROSIA TRIFIDA POLLEN | .05 g/mL |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fb7ab793-2c12-4079-b100-a64f73bef25a | Product name | 4 | 20240712 |
| b0cbf770-6cc3-4aa4-9158-755110c2b9f7 | Product name | 2 | 20230717 |
| dc7c5daa-021f-40dd-b00d-63982cb2067a | Product name | 1 | 20230426 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 5 | 20200925 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65044-2315-1 | Pollens - Weeds and Garden Plants, Ragweed, Mixed Ambrosia | 5 mL in 1 VIAL | INJECTION, SOLUTION | 5 | 18 | |
| 65044-2315-2 | Pollens - Weeds and Garden Plants, Ragweed, Mixed Ambrosia | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | 18 | |
| 65044-2315-4 | Pollens - Weeds and Garden Plants, Ragweed, Mixed Ambrosia | 50 mL in 1 VIAL | INJECTION, SOLUTION | 50 | 18 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 65044-2315 | POLLENS - WEEDS AND GARDEN PLANTS, SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA (SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA) INJECTION, SOLUTION POLLENS - WEEDS AND GARDEN PLANTS, RAGWEED, MIXED AMBROSIA (RAGWEED, MIXED AMBROSIA) INJECTION, SOLUTION [JUBILANT HOLLISTERSTIER LLC] | 16 | Current NDC, Legacy NDC, 3 package rows | 20241103_4801db3b-3738-49e0-b047-1bfb4f85349a.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 896195 | giant ragweed pollen extract 20,000 UNT/mL / western ragweed pollen extract 20,000 UNT/mL Injectable Solution | PSN | 4801db3b-3738-49e0-b047-1bfb4f85349a | 18 |
| 896177 | giant ragweed pollen extract 50 MG/ML / short ragweed pollen extract 50 MG/ML Injectable Solution | PSN | 4801db3b-3738-49e0-b047-1bfb4f85349a | 18 |
| 896201 | giant ragweed pollen extract 500 UNT/ML / short ragweed pollen extract 500 UNT/ML Injectable Solution | PSN | 4801db3b-3738-49e0-b047-1bfb4f85349a | 18 |
| 896138 | short ragweed pollen extract 50 MG/ML Injectable Solution | PSN | 4801db3b-3738-49e0-b047-1bfb4f85349a | 18 |
| 896150 | short ragweed pollen extract 500 UNT/ML Injectable Solution | PSN | 4801db3b-3738-49e0-b047-1bfb4f85349a | 18 |
| 896195 | giant ragweed pollen extract 20000 UNT/ML / western ragweed pollen extract 20000 UNT/ML Injectable Solution | SCD | 4801db3b-3738-49e0-b047-1bfb4f85349a | 18 |
| 896177 | giant ragweed pollen extract 50 MG/ML / western ragweed pollen extract 50 MG/ML Injectable Solution | SCD | 4801db3b-3738-49e0-b047-1bfb4f85349a | 18 |
| 896201 | giant ragweed pollen extract 500 UNT/ML / western ragweed pollen extract 500 UNT/ML Injectable Solution | SCD | 4801db3b-3738-49e0-b047-1bfb4f85349a | 18 |
| 896138 | short ragweed pollen extract 50 MG/ML Injectable Solution | SCD | 4801db3b-3738-49e0-b047-1bfb4f85349a | 18 |
| 896150 | short ragweed pollen extract 500 UNT/ML Injectable Solution | SCD | 4801db3b-3738-49e0-b047-1bfb4f85349a | 18 |
| 896177 | Ambrosia artemisiifolia pollen extract 0.05 GM/ML / Ambrosia trifida pollen extract 0.05 GM/ML Injectable Solution | SY | 4801db3b-3738-49e0-b047-1bfb4f85349a | 18 |
| 896138 | Ambrosia artemisiifolia pollen extract 0.05 GM/ML Injectable Solution | SY | 4801db3b-3738-49e0-b047-1bfb4f85349a | 18 |
| 896195 | Ambrosia artemisiifolia pollen extract 20,000 PNU/ML / Ambrosia trifida pollen extract 20,000 PNU/ML Injectable Solution | SY | 4801db3b-3738-49e0-b047-1bfb4f85349a | 18 |
| 896195 | Ambrosia artemisiifolia pollen extract 20,000 UNT/ML / Ambrosia trifida pollen extract 20,000 UNT/ML Injectable Solution | SY | 4801db3b-3738-49e0-b047-1bfb4f85349a | 18 |
| 896177 | Ambrosia artemisiifolia pollen extract 50 MG/ML / Ambrosia trifida pollen extract 50 MG/ML Injectable Solution | SY | 4801db3b-3738-49e0-b047-1bfb4f85349a | 18 |
| 896138 | Ambrosia artemisiifolia pollen extract 50 MG/ML Injectable Solution | SY | 4801db3b-3738-49e0-b047-1bfb4f85349a | 18 |
| 896201 | Ambrosia artemisiifolia pollen extract 500 UNT/ML / Ambrosia trifida pollen extract 500 UNT/ML Injectable Solution | SY | 4801db3b-3738-49e0-b047-1bfb4f85349a | 18 |
| 896150 | Ambrosia artemisiifolia pollen extract 500 UNT/ML Injectable Solution | SY | 4801db3b-3738-49e0-b047-1bfb4f85349a | 18 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 65044-2315-1 | 65044231501 | 5 mL in 1 VIAL (65044-2315-1) | 5 ml | 1977-10-18 | 0000-00-00 | No | No | Current |
| 65044-2315-2 | 65044231502 | 10 mL in 1 VIAL (65044-2315-2) | 10 ml | 1977-10-18 | 0000-00-00 | No | No | Current |
| 65044-2315-3 | 65044231503 | 30 mL in 1 VIAL (65044-2315-3) | 30 ml | 1977-10-18 | 0000-00-00 | No | No | Current |
| 65044-2315-4 | 65044231504 | 50 mL in 1 VIAL (65044-2315-4) | 50 ml | 1977-10-18 | 0000-00-00 | No | No | Current |