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 |
|---|---|---|---|---|---|---|
| SODIUM CHLORIDE | SODIUM CHLORIDE | Baxter Healthcare Corporation | 123bd10a-90c7-499e-97f6-acf7e0f0fb4e | 2022-07-29 | Warnings, Adverse reactions | 451W47IQ8X |
| Herplex | ANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIA | Nashco Products LLC | fad9615f-7004-415d-9f69-ee9ff95f0067 | 2022-07-12 | Warnings | 451W47IQ8X |
| BHI Constipation | DIOSCOREA VILLOSA TUBER, SODIUM CHLORIDE, AND STRYCHNOS NUX-VOMICA SEED | MediNatura Inc | 0365b75b-fee4-4c1d-89ab-c692bdd73f75 | 2022-07-07 | Warnings | 451W47IQ8X |
| Natrium Muriaticum 6X | SODIUM CHLORIDE | Seroyal USA | 0ebf18de-12fe-0bc4-e054-00144ff88e88 | 2022-07-07 | Warnings | 451W47IQ8X |
| REFRESH Optive Mega-3 | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80 | Allergan, Inc. | c5f2b3f2-2071-45bd-a010-67f848bc0233 | 2022-06-30 | Warnings | 6OZP39ZG8H |
| Erogetone | ARALIA QUINQUEFOLIA, BERBERIS VULGARIS, CAUSTICUM, CONIUM MACULATUM, DAMIANA, GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIA | Energique, Inc. | 1e872ecd-e7a5-463d-9832-47b7046096db | 2022-06-28 | Warnings | 451W47IQ8X |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | f42ac50f-0ec5-4713-a4c8-99d972d90bed | 2022-06-22 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | e71c6c83-d518-496c-b2ab-efd5987e4783 | 2022-06-09 | Warnings, Adverse reactions | 059QF0KO0R |
| Cardioplegic Solution | POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDE | Fresenius Kabi, USA, LLC | eb360dc4-88d6-4b28-9b61-bc359e16bd22 | 2022-05-27 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | 24a08a93-df23-474b-873e-c59ec8855f9f | 2022-03-14 | Warnings, Adverse reactions | 451W47IQ8X |
| Wild Horse 777 Moisturizing Nasal | SODIUM CHLORIDE | Wild Horse 777, Inc. | b0b4dadd-11fa-3dbb-e053-2995a90a2097 | 2022-03-14 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | cc14fafd-3dcd-4fc8-bdbd-6f355c375768 | 2022-02-23 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | 8b44bfd3-70a4-4b47-bc7b-590f63b8cc75 | 2022-02-15 | Warnings, Adverse reactions | 451W47IQ8X |
| ACNE HP | CARBO ANIMALIS, ACTIVATED CHARCOAL, POTASSIUM DICHROMATE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, SULFUR, ZINC | Natural Creations, Inc. | b2368ab6-e233-4473-99fa-86e1fbc2a879 | 2022-02-14 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | f62481fd-fcdb-4be6-ac13-29c590e925c3 | 2022-02-10 | Adverse reactions | 451W47IQ8X |
| Sterile Water | WATER | American Regent, Inc. | 78b35864-4bbc-4759-a5c1-7e4f25e22932 | 2022-01-31 | Boxed warning | 059QF0KO0R |
| Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | e44c41ae-c9c8-4dd8-ba6c-cebb585378aa | 2022-01-31 | Warnings, Adverse reactions | 451W47IQ8X |
| Sterile Saline Mist Walgreens | SODIUM CHLORIDE | WALGREEN COMPANY | d6b9d4fc-b758-be32-e053-2995a90a2523 | 2022-01-29 | Warnings | 451W47IQ8X |
| Extra Strenght Saline Mist Rite Aid | SODIUM CHLORIDE | RITE AID CORPORATION | d5b30fb2-4052-4a0c-e053-2a95a90aacd5 | 2022-01-16 | Warnings | 451W47IQ8X |
| Sterile Saline Mist Rite Aid | SODIUM CHLORIDE | RITE AID | d583067e-1133-7d7d-e053-2a95a90a1e36 | 2022-01-13 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.