Standardized Grass Pollen, Sweet Vernal Grass
- Product NDC
- 65044-0828
- 11-digit product format
- 650440828
- Labeler code
- 65044
- Product ID
- 65044-0828_76062435-a734-468d-88f3-d07042e05fea
- Type
- STANDARDIZED ALLERGENIC
- Nonproprietary name
- Standardized Grass Pollen, Sweet Vernal Grass
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRADERMAL
- Labeler
- Jubilant HollisterStier LLC
- Application
- BLA103878
- Marketing category
- BLA
- Marketing start
- 1998-01-15
- Marketing end
- 0000-00-00
- Substance
- ANTHOXANTHUM ODORATUM POLLEN
- Active strength
- 1000 [BAU]/mL
- Pharmacologic classes
- Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 65044-0828 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 65044-0828 | 65044-0828-5 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 65044-0828-5 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 65044-0828-5 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 65044-0828-5 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 65044-0828-5 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 65044-0828-5 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 65044-0828-5 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 65044-0828-5 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 65044-0828-5 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 65044-0828-5 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 65044-0828-5 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 65044-0828-5 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 65044-0828-5 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 65044-0828-5 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 65044-0828-5 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 65044-0828-5 | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 65044-0828-5 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 65044-0828-5 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 65044-0828-5 | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 65044-0828-5 | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 65044-0828-5 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 65044-0828-5 | 9bebd1f3094a… | 5416666fcb17… |
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 65044-0828-5 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-cf3e-f424-e053-dadaa90a57ce | ALLERGENIC EXTRACTS STANDARDIZED GRASS POLLEN (glycerinated) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65044-0828-5 | Standardized Grass Pollen, Sweet Vernal Grass | 5 mL in 1 VIAL | INJECTION, SOLUTION | 5 | 6 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 65044-0828 | STANDARDIZED GRASS POLLEN, BLUEGRASS, KENTUCKY JUNE INJECTION, SOLUTION STANDARDIZED GRASS POLLEN, FESCUE, MEADOW INJECTION, SOLUTION STANDARDIZED GRASS POLLEN, ORCHARD GRASS INJECTION, SOLUTION STANDARDIZED GRASS POLLEN, REDTOP INJECTION, SOLUTION STANDARDIZED GRASS POLLEN, RYEGRASS INJECTION, SOLUTION STANDARDIZED GRASS POLLEN, SWEET VERNAL GRASS INJECTION, SOLUTION STANDARDIZED GRASS POLLEN, TIMOTHY INJECTION, SOLUTION STANDARDIZED GRASS POLLEN, BERMUDA GRASS INJECTION, SOLUTION [JUBILANT HOLLISTERSTIER LLC] | 6 | Legacy NDC, 1 package rows | 20180620_b3a16cd6-45ae-4625-bdfb-208f5e28235d.zip |
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 103878 | Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum | 351(a) | Rx | 2026-06-01 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 853988 | Bermuda grass pollen extract 100 BAU/ML Injectable Solution | PSN | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854021 | Kentucky bluegrass pollen extract 100 BAU/mL Injectable Solution | PSN | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854023 | Kentucky bluegrass pollen extract 1000 BAU/mL Injectable Solution | PSN | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854006 | meadow fescue grass pollen extract 100 BAU/ML Injectable Solution | PSN | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854004 | meadow fescue grass pollen extract 1000 BAU/ML Injectable Solution | PSN | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 853990 | orchard grass pollen extract 100 BAU/ML Injectable Solution | PSN | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 853992 | orchard grass pollen extract 1000 BAU/ML Injectable Solution | PSN | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854013 | perennial rye grass pollen extract 100 BAU/ML Injectable Solution | PSN | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854015 | perennial rye grass pollen extract 1000 BAU/ML Injectable Solution | PSN | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854154 | redtop grass pollen extract 100 BAU/ML Injectable Solution | PSN | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854156 | redtop grass pollen extract 1000 BAU/ML Injectable Solution | PSN | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854158 | sweet vernal grass pollen extract 100 BAU/ML Injectable Solution | PSN | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854160 | sweet vernal grass pollen extract 1000 BAU/ML Injectable Solution | PSN | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854017 | Timothy grass pollen extract 100 BAU/mL Injectable Solution | PSN | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854019 | Timothy grass pollen extract 1000 BAU/mL Injectable Solution | PSN | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 853988 | Bermuda grass pollen extract 100 BAU/ML Injectable Solution | SCD | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854021 | Kentucky bluegrass pollen extract 100 BAU/ML Injectable Solution | SCD | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854023 | Kentucky bluegrass pollen extract 1000 BAU/ML Injectable Solution | SCD | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854006 | meadow fescue grass pollen extract 100 BAU/ML Injectable Solution | SCD | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854004 | meadow fescue grass pollen extract 1000 BAU/ML Injectable Solution | SCD | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 853990 | orchard grass pollen extract 100 BAU/ML Injectable Solution | SCD | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 853992 | orchard grass pollen extract 1000 BAU/ML Injectable Solution | SCD | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854013 | perennial rye grass pollen extract 100 BAU/ML Injectable Solution | SCD | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854015 | perennial rye grass pollen extract 1000 BAU/ML Injectable Solution | SCD | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854154 | redtop grass pollen extract 100 BAU/ML Injectable Solution | SCD | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854156 | redtop grass pollen extract 1000 BAU/ML Injectable Solution | SCD | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854158 | sweet vernal grass pollen extract 100 BAU/ML Injectable Solution | SCD | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854160 | sweet vernal grass pollen extract 1000 BAU/ML Injectable Solution | SCD | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854017 | Timothy grass pollen extract 100 BAU/ML Injectable Solution | SCD | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854019 | Timothy grass pollen extract 1000 BAU/ML Injectable Solution | SCD | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854154 | Agrostis gigantea pollen extract 100 BAU/ML Injectable Solution | SY | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854156 | Agrostis gigantea pollen extract 1000 BAU/ML Injectable Solution | SY | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854158 | Anthoxanthum odoratum grass pollen extract 100 BAU/ML Injectable Solution | SY | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854160 | Anthoxanthum odoratum grass pollen extract 1000 BAU/ML Injectable Solution | SY | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 853988 | Cynodon dactylon pollen extract 100 BAU/ML Injectable Solution | SY | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 853990 | Dactylis glomerata pollen extract 100 BAU/ML Injectable Solution | SY | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 853992 | Dactylis glomerata pollen extract 1000 BAU/ML Injectable Solution | SY | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854006 | Festuca elatior grass pollen extract 100 BAU/ML Injectable Solution | SY | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854004 | Festuca elatior grass pollen extract 1000 BAU/ML Injectable Solution | SY | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854006 | Festuca pratensis grass pollen extract 100 BAU/ML Injectable Solution | SY | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854004 | Festuca pratensis grass pollen extract 1000 BAU/ML Injectable Solution | SY | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854021 | June grass pollen extract 100 BAU/ML Injectable Solution | SY | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854023 | June grass pollen extract 1000 BAU/ML Injectable Solution | SY | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854013 | Lolium perenne grass pollen extract 100 BAU/ML Injectable Solution | SY | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854015 | Lolium perenne grass pollen extract 1000 BAU/ML Injectable Solution | SY | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854006 | Lolium pratense grass pollen extract 100 BAU/ML Injectable Solution | SY | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854004 | Lolium pratense grass pollen extract 1000 BAU/ML Injectable Solution | SY | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854017 | Phleum pratense grass pollen extract 100 BAU/ML Injectable Solution | SY | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854019 | Phleum pratense grass pollen extract 1000 BAU/ML Injectable Solution | SY | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854021 | Poa pratensis grass pollen extract 100 BAU/ML Injectable Solution | SY | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854023 | Poa pratensis grass pollen extract 1000 BAU/ML Injectable Solution | SY | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854006 | Schedonorus pratensis grass pollen extract 100 BAU/ML Injectable Solution | SY | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
| 854004 | Schedonorus pratensis grass pollen extract 1000 BAU/ML Injectable Solution | SY | b3a16cd6-45ae-4625-bdfb-208f5e28235d | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 65044-0828-5 | 65044082805 | 5 mL in 1 VIAL | 5 ml | Historical |