NDC 58160-815-01 - TWINRIX
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
- 58160-815
- Requested NDC
- 58160-815-01
- Package NDCs from labels
- 58160-815-43, 58160-815-52, 58160-815-01
- Manufacturer
- GlaxoSmithKline Biologicals SA
- Effective date
- 2026-05-14
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| TWINRIX - GlaxoSmithKline Biologicals SA | GlaxoSmithKline Biologicals SA | 2026-05-14 | VACCINE LABEL |
| TWINRIX - A-S Medication Solutions | A-S Medication Solutions | 2023-12-09 | VACCINE LABEL |
| National Council for Prescription Drug Programs indexing - billing unit | National Council for Prescription Drug Programs | 2013-03-03 | Indexing - Billing Unit |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58160-815-43 | TWINRIX | 1 mL in 1 SYRINGE | INJECTION, SUSPENSION | 1 | 34 | |
| 58160-815-52 | TWINRIX | 10 in 1 CARTON | INJECTION, SUSPENSION | 10 | 34 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58160-815 | TWINRIX (HEPATITIS A AND HEPATITIS B (RECOMBINANT) VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA] | 31 | Current NDC, Legacy NDC, 2 package rows | 20250426_18e8f9fc-4d62-4d30-4ab7-bac03336171e.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 58160-815-01 | ML - Milliliter | 58160-815 | 79a62666-e61f-4634-bb9d-391a857ac929 | 1 | 2013-03-03 |
| 58160-815-05 | ML - Milliliter | 58160-815 | 3c471fe2-8626-49b2-aae2-df1498272405 | 1 | 2016-01-13 |
| 58160-815-11 | ML - Milliliter | 58160-815 | d3547a57-b73b-4bf3-86cd-e9ce7ab5c05e | 1 | 2013-02-13 |
| 58160-815-32 | ML - Milliliter | 58160-815 | ab485cc7-d968-4b1a-a574-90c6e747884d | 1 | 2013-03-03 |
| 58160-815-34 | ML - Milliliter | 58160-815 | e6a16786-5348-4fec-bbbd-af112333be9a | 1 | 2016-01-13 |
| 58160-815-43 | ML - Milliliter | 58160-815 | 14301346-3bcd-4a08-aa21-dc0193c71ba6 | 1 | 2013-03-03 |
| 58160-815-52 | ML - Milliliter | 58160-815 | eaa2da79-0201-432c-b977-758ec7f11d13 | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
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 | Hospira, Inc. | 3a6422e1-feee-4095-8883-2b0837039e6e | 2026-05-07 | Warnings, Adverse reactions | 059QF0KO0R |
| Harris Teeter Triple Antibiotic | NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC | HARRIS TEETER LLC | 4e81590c-32d3-f8aa-e063-6294a90ab341 | 2026-05-06 | Warnings | 057Y626693 |
| Viril | BENZOICUM ACIDUM, CALADIUM SEGUINUM, CHIMAPHILA UMBELLATA, CLEMATIS ERECTA, RHODODENDRON, SABAL SERRULATA, NATRUM MURIATICUM, CORTISONE ACETICUM, HYPOTHALAMUS SUIS, PROSTATE (SUIS), TESTOSTERONE, AGNUS CASTUS, AURUM METALLICUM, BRYONIA (ALBA), CONIUM MACULATUM, LYCOPODIUM CLAVATUM, SELENIUM METALLICUM, SEPIA, THUJA OCCIDENTALIS, KALI ARSENICOSUM, BUFO RANA | Deseret Biologicals, Inc. | 3701cc0d-91ed-45fd-98b8-9d8cfba9c787 | 2026-05-06 | Warnings | 451W47IQ8X |
| GERI-LANTA ANTACID ANTIGAS | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | Preferred Pharmaceuticals Inc. | 27848ae0-3b2f-4bfe-8856-4b8de419091e | 2026-05-06 | Warnings | 5QB0T2IUN0 |
| REGULAR STRENGTH ANTACID | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | Preferred Pharmaceuticals Inc. | ad3e7ebe-f2a9-4305-b370-59785f5396c8 | 2026-05-06 | Warnings | 5QB0T2IUN0 |
| Multi Flower | AESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOS | Energique, Inc. | 09c059e7-f748-402c-8447-af5b61169c58 | 2026-05-06 | Warnings | 059QF0KO0R |
| FIRSTAR TRIPLE ANTIBIOTIC | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Nantong Health & Beyond Hygienic Products Inc. | 5b9434ad-83d7-4df3-bfef-3db152e6c6cc | 2026-05-04 | Warnings | 057Y626693 |
| oopsie First Aid | BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE | 4 Visions LLC | 50b21f0a-1e87-51ae-e063-6294a90a8a3c | 2026-04-30 | Warnings | 057Y626693 |
| Sodium Chloride | SODIUM CHLORIDE | Sportpharm LLC | a2c111f6-74d5-4a5d-82ac-d0f237488cb8 | 2026-04-24 | Warnings, Adverse reactions | 451W47IQ8X |
| Neomycin Sulfate | NEOMYCIN SULFATE | REMEDYREPACK INC. | 461f62b9-b9ec-43f2-aee7-0895638105b8 | 2026-04-24 | Boxed warning, Warnings, Adverse reactions | 057Y626693 |
| Sodium Chloride | SODIUM CHLORIDE | Method Pharmaceuticals, LLC | 4b08859e-65bd-8255-e063-6394a90af614 | 2026-04-23 | Warnings | 451W47IQ8X |
| Ringers | SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE | ICU Medical, Inc. | a926f913-18fa-4a3e-bfd6-210e1e427960 | 2026-04-20 | Warnings, Adverse reactions | 451W47IQ8X |
| Cardioforce II | ABROTANUM, BOLDO, CIMICIFUGA RACEMOSA, KALI PHOSPHORICUM, TARAXACUM OFFICINALE, CONVALLARIA MAJALIS, MAGNESIA SULPHURICA, OLEANDER, NATRUM MURIATICUM, BELLIS PERENNIS | BioActive Nutritional, Inc. | 733bbb26-7698-4a1b-9dc8-7e3490ffc92b | 2026-04-17 | Warnings | 451W47IQ8X |
| Thyroid HP | BARYTA CARBONICA, CALCAREA CARBONICA, FUCUS VESICULOSUS, IODIUM, NATRUM MURIATICUM, PULSATILLA, SPONGIA TOSTA, THYROIDINUM (SUIS) | BioActive Nutritional, Inc. | 3795820a-cf2a-4094-9a02-70e3757b7510 | 2026-04-17 | Warnings | 451W47IQ8X |
| DIANEAL Low Calcium with Dextrose | SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE | Vantive US Healthcare LLC | aa268d3f-7389-4f25-801f-5d4825495f08 | 2026-04-16 | Warnings, Adverse reactions | 451W47IQ8X |
| PEG 3350 and Electrolytes | POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE | Wilshire Pharmaceuticals, Inc. | b251752d-7750-482a-9364-0acf4ad47cc8 | 2026-04-16 | Warnings, Adverse reactions | 451W47IQ8X |
| Dextrose and Sodium Chloride | DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE | Fresenius Kabi USA, LLC | 99c6a1a9-cadf-435b-a332-ccc189afdfa9 | 2026-04-16 | Warnings, Adverse reactions | 451W47IQ8X |
| Antacid | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE | Rugby Laboratories | bd58baac-5790-455a-9c77-236680992579 | 2026-04-15 | Warnings | 5QB0T2IUN0 |
| Family Care Antibiotic Pain Relief 0.33oz | ANTIBIOTIC PAIN RELIEF | United Exchange Corp | 4f8405fc-3e38-05d9-e063-6394a90a4cda | 2026-04-15 | Warnings | 057Y626693 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE. | TRIFECTA PHARMACEUTICALS USA LLC | 23a35ba8-ebc6-4252-bb88-ec237425056c | 2026-04-15 | Warnings | 057Y626693 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.