NDC 43528-003-01 - HEPLISAV-B
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 43528-003
- Requested NDC
- 43528-003-01
- Package NDCs from labels
- 43528-003-01, 43528-003-05
- Manufacturer
- A-S Medication Solutions
- Effective date
- 2026-09-18
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| HEPLISAV-B - A-S Medication Solutions | A-S Medication Solutions | 2026-09-18 | VACCINE LABEL |
| HEPLISAV-B - Dynavax Technologies Corporation | Rhein Biotech GmbH | Dynavax Technologies Corporation | Rhein Biotech GmbH | 2026-02-19 | VACCINE LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43528-003-01 | HEPLISAV-B | 0.5 mL in 1 SYRINGE | INJECTION, SOLUTION | 0.5 | 10 | |
| 43528-003-05 | HEPLISAV-B | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | 10 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 43528-003 | HEPLISAV-B (HEPATITIS B VACCINE (RECOMBINANT) ADJUVANTED) INJECTION, SOLUTION [DYNAVAX TECHNOLOGIES CORPORATION] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240920_d61c7f99-438b-4cac-ae10-997ff4c0fd1f.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43528-003-01 | ML - Milliliter | 43528-003 | c15dcb4a-a60d-4115-a840-884a227c2633 | 1 | 2018-08-13 |
| 43528-003-05 | ML - Milliliter | 43528-003 | c5c697f3-6361-4830-844a-05382fa0c562 | 1 | 2018-08-13 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Tox-Chord | ALFALFA, ALUMINA, BENZOICUM ACIDUM, CARBONEUM, CETRARIA ISLANDICA, FOLLICULINUM, FUCUS VESICULOSUS, FUMARICUM ACIDUM, HEPAR SUIS, KALI CARBONICUM, KREOSOTUM, NATRUM MURIATICUM, PARAFFINUM, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PIX LIQUIDA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PULSATILLA (VULGARIS), RADIUM BROMATUM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM OFFICINALE, TABACUM, TEREBINTHINA, THYROIDINUM (BOVINE), TRITICUM REPENS, ZINCUM OXYDATUM | Energetix Corp | 6b0d1628-b20d-426e-9c84-5cceadca3f45 | 2016-11-11 | Warnings | 451W47IQ8X |
| Sterile Water | WATER | Baxter Healthcare Company | 210dc9ab-d6ca-4552-ac19-1be17792d290 | 2016-05-31 | Warnings, Adverse reactions | 059QF0KO0R |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Corporation | 2a96096d-43cc-49b7-af53-b53c17f41001 | 2014-07-25 | Warnings, Adverse reactions | 451W47IQ8X |
| SODIUM CHLORIDE | SODIUM CHLORIDE | Baxter Healthcare Corporation | b3b4b176-41f0-4ca8-90d4-3fba5707564a | 2014-02-21 | 451W47IQ8X | |
| TIS-U-SOL | SODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATE | Baxter Healthcare Corporation | 9da4121f-d62d-4da4-8dfb-0494da16015f | 2014-02-21 | 451W47IQ8X | |
| Ringers | SODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE, | Baxter Healthcare Corporation | e1953d54-818d-46a6-8532-518ebae6d84e | 2012-06-13 | 451W47IQ8X | |
| Lactated Ringers | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE | Baxter Healthcare Corporation | f09f80bf-2f8b-4420-865d-aec2d5e5cd4d | 2012-06-12 | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.