NDC 58160-816 - Hiberix
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
- 58160-816
- Package NDCs from labels
- 58160-816-01, 58160-816-05, 58160-816-03
- Manufacturer
- GlaxoSmithKline Biologicals SA
- Effective date
- 2025-01-21
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Hiberix - GlaxoSmithKline Biologicals SA | GlaxoSmithKline Biologicals SA | 2025-01-21 | VACCINE LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58160-816-01 | Hiberix | 0.5 mL in 1 VIAL | INJECTION, POWDER, FOR SOLUTION | 5 mL | 10 ug in 0.5mL | 22 |
| 58160-816-03 | Hiberix | 0.5 mL in 1 VIAL | INJECTION, POWDER, FOR SOLUTION | 5 mL | 10 ug in 0.5mL | 22 |
| 58160-816-05 | Hiberix | 10 in 1 CARTON | INJECTION, POWDER, FOR SOLUTION | 10 ug in 0.5mL | 22 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN | ACTIVE INGREDIENT | C9R35M8XV6 | HIBERIX (HAEMOPHILUS B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE)) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAXOSMITHKLINE BIOLOGICALS SA] | 8 | |
| HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN | ACTIVE MOIETY | C9R35M8XV6 | HIBERIX (HAEMOPHILUS B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE)) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAXOSMITHKLINE BIOLOGICALS SA] | 8 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | HIBERIX (HAEMOPHILUS B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE)) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAXOSMITHKLINE BIOLOGICALS SA] | 8 |
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 |
|---|---|---|---|---|---|---|
| Muro 128 | SODIUM CHLORIDE | Bausch & Lomb Incorporated | 454f337e-d897-46de-ab05-1c543a33061c | 2024-09-25 | Warnings | 451W47IQ8X |
| Defense | PETROSELINUM SATIVUM, NATRUM MURIATICUM, HEPAR (BOVINE), MEDULLA OSSIS SUIS, SPLEEN (BOVINE), THYMUS (OVINE), SACCHARINUM | Nutritional Specialties, Inc. | ddd879cf-1a85-4b8d-bdb0-5cf495fea4e6 | 2024-09-24 | Warnings | 451W47IQ8X |
| HP Axis | ARGENTUM NITRICUM, BERBERIS VULGARIS, IODIUM, KALI CARBONICUM, NATRUM MURIATICUM, ADRENALINUM, CORTISONE ACETICUM, DHEA, GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, MELATONIN, TESTOSTERONE, ARSENICUM ALBUM, PHOSPHORUS, PROTEUS (VULGARIS), SEPIA, SILICEA, ALLOXANUM, CORTICOTROPIN RELEASING HORMONE, ADRENOCORTICOTROPHIN, ALDOSTERONE | Deseret Biologicals, Inc. | 402f5b05-c71e-4dba-bc2b-049aee42952a | 2024-09-23 | Warnings | 451W47IQ8X |
| Dextrose and Sodium Chloride | DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE | Fresenius Kabi USA, LLC | 3c5f0f65-8a54-4a55-ad4e-0f0be97631d7 | 2024-09-15 | Warnings, Adverse reactions | 451W47IQ8X |
| Thyroid HP | BARYTA CARBONICA, CALCAREA CARBONICA, CALCAREA IODATA, FUCUS VESICULOSUS, IODIUM, NATRUM MURIATICUM, PULSATILLA (VULGARIS), SPONGIA TOSTA, THYROIDINUM (SUIS) | Energique, Inc. | 3a4f9647-a4d9-4bca-96d1-ec717f938d4a | 2024-09-11 | Warnings | 451W47IQ8X |
| Defense | PETROSELINUM SATIVUM, NATRUM MURIATICUM, HEPAR SUIS, MEDULLA OSSIS SUIS, SPLEEN (BOVINE), THYMUS (BOVINE) SACCHARINUM | Nutritional Specialties, Inc. | b5516749-54dd-4287-b2db-78164810de7a | 2024-09-11 | Warnings | 451W47IQ8X |
| Dairy Allergen Mix | ADENOSINUM TRIPHOSPHORICUM DINATRUM, BENZOICUM ACIDUM, CHOLINUM, CINNAMIC ACID, EUGENOL, FOLIC ACID, FORMALINUM, HISTAMINUM HYDROCHLORICUM, L-ASPARAGINE (MONOHYDRATE), LAC DEFLORATUM, LAC VACCINUM, MENADIONE, OOPHORINUM (SUIS), PETROSELINUM SATIVUM, PHENYL ISOTHIOCYANATE, QUERCETIN, RUTIN, SACCHARUM LACTIS, ILEUM (SUIS), JEJUNUM (SUIS), STOMACH (SUIS), COUMARINUM, FOLLICULINUM, GABA (GAMMA-AMINOBUTYRIC ACID), SARCOLACTICUM ACIDUM, LAC CANINUM, LAC FELINUM, LAC HUMANUM, PIPERINE, CALCAREA CARBONICA, | Deseret Biologicals, Inc. | e03d8463-287a-4509-a9f4-0ad38a98377c | 2024-09-11 | Warnings | J2B2A4N98G |
| Itch Formula | CALENDULA OFFICINALIS, APIS MELLIFICA, NATRUM MURIATICUM, URTICA URENS, HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, SULPHUR, COPAIVA OFFICINALIS, CANTHARIS, CROTON TIGLIUM, GRAPHITES, MEZEREUM, PETROLEUM, RHUS VENENATA, STAPHYSAGRIA, ANTIPYRINUM | Deseret Biologicals, Inc. | 79c21a7b-ffb7-4b0d-a702-8aec0463be81 | 2024-09-11 | Warnings | 451W47IQ8X |
| Dairy Allergen Mix | ADENOSINUM TRIPHOSPHORICUM DINATRUM, BENZOICUM ACIDUM, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCIUM CITRATE, CALCIUM GLUCONATE, CARBO VEGETABILIS, CHAMOMILLA, CHOLINUM, CINNAMIC ACID, COUMARINUM, EUGENOL, FOLIC ACID, FOLLICULINUM, FORMALINUM, GABA (GAMMA-AMINOBUTYRIC ACID), GAERTNER BACILLUS (BACH), HISTAMINUM HYDROCHLORICUM, ILEUM (SUIS), JEJUNUM (SUIS), L-ASPARAGINE (MONOHYDRATE), LAC CANINUM, LAC DEFLORATUM, LAC FELINUM, LAC HUMANUM, LAC VACCINUM, MENADIONE, | Deseret Biologicals, Inc. | e2bc26d2-1719-40c5-a6f9-8ff1f364c3cf | 2024-09-06 | Warnings | J2B2A4N98G |
| Adrenal Liquescence | GLYCYRRHIZA GLABRA, ROSA CANINA, ARALIA QUINQUEFOLIA (AMERICAN GINSENG), GLANDULA SUPRARENALIS (BOVINE), ADRENALINUM, EPHEDRA VULGARIS, NATRUM MURIATICUM, ZINCUM METALLICUM, ADRENOCORTICOTROPHIN | Nutritional Specialties, Inc. | 9f8e7917-33df-4059-9ae9-e3d2fbb8e319 | 2024-09-03 | Warnings | 451W47IQ8X |
| Gum Therapy | ACONITUM NAPELLUS, ARNICA MONTANA, BISMUTHUM SUBNITRICUM, BORAX, CALCAREA FLUORICA, CALENDULA OFFICINALIS, CISTUS CANADENSIS, HEPAR SULPHURIS CALCAREUM, KALI PHOSPHORICUM, KREOSOTUM, MERCURIUS VIVUS, MYRRHA, NATRUM MURIATICUM, SEPIA | Deseret Biologicals | ceb5203b-b4c8-4c7b-8e18-ccbff5034fc1 | 2024-08-29 | Warnings | 451W47IQ8X |
| Gum Therapy | CALENDULA OFFICINALIS, KALI PHOSPHORICUM, NATRUM MURIATICUM, ARNICA MONTANA, BORAX, CISTUS CANADENSIS, KREOSOTUM, MYRRHA, CALCAREA FLUORICA, ACONITUM NAPELLUS, BISMUTHUM SUBNITRICUM, SEPIA, HEPAR SULPHURIS CALCAREUM, MERCURIUS VIVUS | Deseret Biologicals | 5c741edc-f3ce-4e43-bb3e-fb7316621406 | 2024-08-28 | Warnings | 451W47IQ8X |
| Upper Respiratory Support | ALLIUM CEPA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, SALVIA OFFICINALIS, DULCAMARA, EUPHRASIA OFFICINALIS, HYDRASTIS CANADENSIS, NATRUM MURIATICUM, SABADILLA, VISCUM ALBUM, MUCOSA NASALIS SUIS, ACONITUM NAPELLUS, AMMONIUM CARBONICUM, ARSENICUM IODATUM, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, KALI BICHROMICUM, MERCURIUS VIVUS, NUX VOMICA, PULSATILLA (PRATENSIS), RHUS TOX | Deseret Biologicals, Inc. | 882a284f-aa25-40cf-8aff-fe4c38ff3f0a | 2024-08-23 | Warnings | 451W47IQ8X |
| Empathy | AETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATA | Deseret Biologicals, Inc. | a89067c1-ef12-49da-8fa6-e65ff664f497 | 2024-08-13 | Warnings | 059QF0KO0R |
| Lymph/Spleen Combo | ADENOSINUM TRIPHOSPHORICUM DINATRUM, APIS MELLIFICA, CASTANEA VESCA, CEANOTHUS AMERICANUS, CHININUM ARSENICOSUM, FERRUM METALLICUM, HELIANTHUS ANNUUS, JUNIPERUS COMMUNIS, LYMPH NODE (SUIS), MYOSOTIS ARVENSIS, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, QUERCUS GLANDIUM SPIRITUS, SPLEEN (SUIS), SUCCINUM, THYMUS (SUIS), UBIDECARENONUM | Deseret Biologicals, Inc. | afce86e2-cbfa-44d4-b803-bc2ad5053357 | 2024-07-31 | Warnings | 451W47IQ8X |
| Lymph/Spleen Combo | JUNIPERUS COMMUNIS, QUERCUS GLANDIUM SPIRITUS, MYOSOTIS ARVENSIS, NATRUM SULPHURICUM, CEANOTHUS AMERICANUS, HELIANTHUS ANNUUS, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, LYMPH NODE (SUIS), SPLEEN (SUIS), THYMUS (SUIS), CHININUM ARSENICOSUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, UBIDECARENONUM, FERRUM METALLICUM, SUCCINUM, CASTANEA VESCA, APIS MELLIFICA | Deseret Biologicals, Inc. | b55787b5-5e35-4342-8f00-ef202c353877 | 2024-07-31 | Warnings | 451W47IQ8X |
| Adrenapar | ARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS SUIS, ARSENICUM IODATUM, CALCAREA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUM | Energique, Inc. | 4080fcfb-7ef2-45f5-8c3b-592d3b66a120 | 2024-07-29 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Corporation | f55bd888-5e01-474d-871b-24654c070178 | 2024-07-24 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | 83994d0c-8484-4505-abb5-8a384ed12288 | 2024-07-22 | Warnings, Adverse reactions | 451W47IQ8X |
| sodium chloride | SODIUM CHLORIDE | Becton Dickinson and Company | 8df7dcf6-8714-6caf-e053-2995a90ab8cc | 2024-07-15 | Warnings, Adverse reactions | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.