NDC 75052-001-01 - PREHEVBRIO
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
- 75052-001
- Requested NDC
- 75052-001-01
- Package NDCs from labels
- 75052-001-01, 75052-001-10
- Manufacturer
- VBI Vaccines (Delaware) Inc. | BioReliance | SciVac Ltd | Envigo CRS (Israel) Limited | Hy-Labs | IMI TAMI Institute for Research and Development Ltd.
- Effective date
- 2024-02-22
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| PREHEVBRIO | VBI Vaccines (Delaware) Inc. | BioReliance | SciVac Ltd | Envigo CRS (Israel) Limited | Hy-Labs | IMI TAMI Institute for Research and Development Ltd. | 2024-02-22 | VACCINE LABEL |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 75052-001-10 | 2025-07-29 | C162847 | 48780-1 | 3b156c62-312a-fb37-e063-e6dba90a4e07 | These highlights do not include all the information needed to use PREHEVBRIO TM safely and effectively. See full prescribing information for PREHEVBRIO. PREHEVBRIO [Hepatitis B Vaccine (Recombinant)] Injectable suspension, for intramuscular use Initial U.S. Approval: 2021 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 75052-001-01 | PREHEVBRIO | 1 mL in 1 VIAL, GLASS | INJECTION, SUSPENSION | 1 | 6 | |
| 75052-001-10 | PREHEVBRIO | 10 in 1 CARTON | INJECTION, SUSPENSION | 10 | 6 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 75052-001-01 | ML - Milliliter | 75052-001 | b0c8c71c-c3f9-46ff-a3c5-52c3e2eca772 | 1 | 2022-02-07 |
| 75052-001-10 | ML - Milliliter | 75052-001 | 893b43ad-57c5-4d07-badb-8347f8ac3adf | 1 | 2022-02-07 |
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 |
|---|---|---|---|---|---|---|
| Lymph Tonic II | ECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANA | BioActive Nutritional, Inc. | 0e3265b0-b210-4a4c-80d2-8a9712981d4e | 2026-09-17 | Warnings | 451W47IQ8X |
| Potassium Chloride Extended-release | POTASSIUM CHLORIDE EXTENDED-RELEASE | REMEDYREPACK INC. | ace1eb11-b925-405a-b772-58c60b3ca7d4 | 2026-09-09 | Warnings, Adverse reactions | 660YQ98I10 |
| Saline | NASAL | Raritan Pharmaceuiticals Inc | 4b178e4e-a10f-4b75-8140-1f7548e203ad | 2026-09-09 | Warnings | 451W47IQ8X |
| Claravie | ALUMINUM HYDROXIDE GEL | Gentell LLC | 5afea757-8feb-f907-e063-6394a90a6259 | 2026-09-08 | Warnings | 5QB0T2IUN0 |
| Thyroid Support | CALCAREA CARBONICA, CALCAREA IODATA, CAUSTICUM, FERRUM IODATUM, FUCUS VESICULOSUS, KALI IODATUM, NATRUM MURIATICUM, THYROIDINUM (BOVINE) | NaturalCare | 07b4e0ed-2b00-4d0a-ad8f-fc6deff15325 | 2026-09-08 | Warnings | 451W47IQ8X |
| Psoriasis Control | CENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDE | Forces of Nature | 2db33771-0bb9-49f8-84fa-dddc28e4ba26 | 2026-09-04 | Warnings | 451W47IQ8X |
| KROGER Saline | NASAL | KROGER COMPANY | c84b242b-f46e-4ea8-a3c1-109a47644646 | 2026-09-02 | Warnings | 451W47IQ8X |
| Adrenal Support | ADRENALINUM, ARGENTUM NITRICUM, BERBERIS VULGARIS, NATRUM MURIATICUM, OLEUM MORRHUAE, PETROLEUM, VANADIUM | NaturalCare | 31a5d522-15cd-432a-bf87-f721bcbe2e31 | 2026-09-02 | Warnings | 451W47IQ8X |
| Xtreme Saline Rinse Mix | SODIUM BICARBONATE, SODIUM CHLORIDE | Xtreme Personal Care Inc | 776f417e-e443-4918-8c7a-1913b7dddcd4 | 2026-09-01 | Warnings | 451W47IQ8X |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC INJECTION, | Amneal Pharmaceuticals Private Limited | 98315c6e-308d-423b-a046-4be1f54d30ae | 2026-09-01 | Warnings, Adverse reactions | 4J9FJ0HL51 |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC INJECTION, | Amneal Pharmaceuticals Private Limited | 125121b8-bc4c-44ee-906e-e72f652a5aa6 | 2026-09-01 | Warnings, Adverse reactions | 4J9FJ0HL51 |
| Kroger Extra Strength | ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE | THE KROGER CO., | 175d9f0f-266a-4dc2-865f-d1ebd4ddac51 | 2026-09-01 | Warnings | 5QB0T2IUN0 |
| Nacl 0.9% Normal Saline Solution | SODIUM CHLORIDE | CHI FUNG TECHNOLOGY COMPANY | 5a53c4c8-c9de-700c-e063-6394a90a3ab5 | 2026-08-31 | Warnings | 451W47IQ8X |
| BMNP Kali Mur | KALIUM MURIATICUM | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 5a546950-3f03-7abf-e063-6294a90a1968 | 2026-08-31 | Warnings | 660YQ98I10 |
| BMNP Nat Mur | NATRUM MURIATICUM | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 5a57ccfd-ab6f-cb2c-e063-6394a90ae9e6 | 2026-08-31 | Warnings | 451W47IQ8X |
| GERI-LANTA MAXIMUM STRENGTH | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | Preferred Pharmaceuticals Inc. | 3b049027-30ac-4c78-a4f1-8191f7ed45bf | 2026-08-27 | Warnings | 5QB0T2IUN0 |
| Allergy Care | ADRENALINUM, RAGWEED, POLLEN (AMBROSIA ARTEMISIAEFOLIA), APIS MELLIFICA, ECHINACEA (ANGUSTIFOLIA), HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHUR | NaturalCare | f3ca7f5a-1448-4670-ac02-b47ffb6c5585 | 2026-08-27 | Warnings | 451W47IQ8X |
| Potassium Chloride Extended-release | POTASSIUM CHLORIDE EXTENDED-RELEASE | REMEDYREPACK INC. | 2c407aaf-5d95-49ff-a5db-f1d7b5190334 | 2026-08-27 | Warnings, Adverse reactions | 660YQ98I10 |
| Antacid | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE | Guardian Drug Company | 48ec50ab-f24b-367b-e063-6294a90ad736 | 2026-08-27 | Warnings | 5QB0T2IUN0 |
| KUGIG ALOE FOAMING INTIMATE WASH | INTIMATE CLEANSING FOAM | Hong Kong KangXing Centennial Management Limited | 59f4d398-1186-a168-e063-6294a90ab44b | 2026-08-26 | Warnings | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.