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 |
|---|---|---|---|---|---|---|
| Sterile Water | WATER | ICU Medical Inc. | aab10f03-26ae-4dbc-a481-ef025e48b405 | 2025-11-02 | Warnings, Adverse reactions | 059QF0KO0R |
| Potassium Chloride in Sodium Chloride | SODIUM CHLORIDE AND POTASSIUM CHLORIDE | ICU Medical Inc. | 9dd1c001-73b3-41d4-9a96-61f6ad3a5dc3 | 2025-11-02 | Warnings, Adverse reactions | 451W47IQ8X |
| Sterile Water | WATER | ICU Medical Inc. | e3484bc6-ed7f-43ef-9d49-c131a8dff2dd | 2025-11-02 | Warnings, Adverse reactions | 059QF0KO0R |
| Sodium Chloride | SODIUM CHLORIDE | ICU Medical Inc. | 3cfdeee0-ff14-4341-8396-b11c2a037c60 | 2025-11-02 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | ICU Medical Inc. | 5f372b75-d7a4-471e-8ac6-290040fc84b0 | 2025-11-02 | Warnings, Adverse reactions | 451W47IQ8X |
| Potassium Chloride in Sodium Chloride | SODIUM CHLORIDE AND POTASSIUM CHLORIDE | ICU Medical Inc. | 243fe8fc-996a-4855-8daf-069628e547c4 | 2025-11-02 | Warnings, Adverse reactions | 451W47IQ8X |
| Lactated Ringers and Dextrose | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE | ICU Medical Inc. | d310d170-5eeb-471b-af1a-0e845001d21d | 2025-11-02 | Warnings, Adverse reactions | 451W47IQ8X |
| Family Care Saline | SODIUM CHLORIDE | United Exchange Corp. | 06737393-d4ae-3e7b-e063-6394a90ac19f | 2025-10-31 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | ICU Medical Inc. | 009bef3c-e8ac-46be-b564-a2556adf0081 | 2025-10-31 | Warnings, Adverse reactions | 451W47IQ8X |
| Potassium Chloride in Lactated Ringers and Dextrose | POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATE | ICU Medical Inc. | 237b39fa-916e-4a54-99c8-4ae9ad54f056 | 2025-10-30 | Warnings, Adverse reactions | 451W47IQ8X |
| Normosol-R and Dextrose | DEXTROSE, SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | ICU Medical Inc. | ead1fca3-eff4-478f-8a8f-67510f80151a | 2025-10-30 | Warnings, Adverse reactions | 451W47IQ8X |
| Normosol-R | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | ICU Medical Inc. | 0e089a44-0cee-4804-8f6f-8508508ddb5c | 2025-10-30 | Warnings, Adverse reactions | 451W47IQ8X |
| Normosol-R | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | ICU Medical Inc. | 189b8ac6-e346-454f-b501-7645590ca4f8 | 2025-10-29 | Warnings, Adverse reactions | 451W47IQ8X |
| Cold and Cough 4 Kids | ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEAL | Hyland's Inc. | e06599ca-fc94-4b2c-829e-f3d4ec866ed6 | 2025-10-29 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Cardinal Health 107, LLC | 97007188-43fe-416c-a87b-6ccc4d9ae2ec | 2025-10-29 | Adverse reactions | 451W47IQ8X |
| Sterile Water | WATER | ICU Medical Inc. | 1c0bbcb7-5ed6-4ee7-b297-080d3359474e | 2025-10-29 | Boxed warning, Warnings, Adverse reactions | 059QF0KO0R |
| Potassium Chloride in Lactated Ringers and Dextrose | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE | Baxter Healthcare Corporation | 05f326e6-10e4-4ceb-8a23-f53c592f00b8 | 2025-10-29 | Warnings, Adverse reactions | 451W47IQ8X |
| Lactated Ringers and Dextrose | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE AND DEXTROSE MONOHYDRATE | Baxter Healthcare Corporation | 6acc9f96-7088-45a7-b48f-1a861e3467ab | 2025-10-29 | Warnings, Adverse reactions | 451W47IQ8X |
| Lactated Ringers | SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM LACTATE AND CALCIUM CHLORIDE | Baxter Healthcare Company | dad7735c-709b-40ea-ab7a-15577e24a966 | 2025-10-29 | Warnings, Adverse reactions | 451W47IQ8X |
| WALMART SALINE | SALINE NASAL (SODIUM CHLORIDE) | WALMART STORES INC | 06906744-49a5-4bab-8539-af2d235df9e8 | 2025-10-28 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.