NDC 68516-3204 - Profilnine
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
- 68516-3204
- Package NDCs from labels
- 68516-3204-1
- Manufacturer
- GRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SA
- Effective date
- 2026-04-01
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Factor IX Complex Profilnine ® | GRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SA | 2026-04-01 | PLASMA DERIVATIVE |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68516-3204-1 | Profilnine | 5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 mL | 500 [iU] in 5mL | 33 |
| 68516-3204-1 | Profilnine | 5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 mL | 500 [iU] in 5mL | 33 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68516-3204 | PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC] | 29 | Unmatched | 20230830_79821042-86a5-4a64-b621-76de0a0bbab2.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| factor ix complex | ACTIVE INGREDIENT | FW411QXD5M | PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC] | 15 | |
| factor ix complex | ACTIVE MOIETY | FW411QXD5M | PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC] | 15 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC] | 15 | |
| sodium citrate | INACTIVE INGREDIENT | 1Q73Q2JULR | PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC] | 15 | |
| sodium phosphate | INACTIVE INGREDIENT | SE337SVY37 | PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC] | 15 |
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 |
|---|---|---|---|---|---|---|
| Anubis Barcelona New Even | LACTIC ACID, CITRIC ACID, GLYCOLIC ACID | ANUBIS COSMETICS SL | eaeeb6e0-5322-20c4-e053-2995a90a9fd9 | 2023-09-01 | Warnings | 059QF0KO0R |
| Ringers | SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE | B. Braun Medical Inc. | b53c598c-dc7d-4a15-9319-8edf265e7b42 | 2023-08-30 | Warnings, Adverse reactions | 451W47IQ8X |
| Anubis Barcelona Vital Line | HYDROLYZED COLLAGEN | ANUBIS COSMETICS SL | f564bbf0-3b5c-4a81-e053-2a95a90a7ea6 | 2023-08-29 | Warnings | 059QF0KO0R |
| BABY MUCUS PLUS COLD RELIEF | BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDE | Hyland's Inc. | d934cc8a-1e43-4942-858a-05b5d068679a | 2023-08-22 | Warnings | 451W47IQ8X |
| Hepaticol Sarcode | CARDUUS MARIANUS, ZINGIBER OFFICINALE, BERBERIS VULGARIS, CHELIDONIUM MAJUS, MAGNESIA MURIATICA, LEPTANDRA VIRGINICA, NATRUM MURIATICUM, BRYONIA (ALBA), HEPAR (BOVINE), NATRUM SULPHURICUM, ATROPINUM SULPHURICUM, LYCOPODIUM CLAVATUM | Nutritional Specialties, Inc. | f9d95b2f-53d9-4017-873f-5ad0b129f9f8 | 2023-08-14 | Warnings | 451W47IQ8X |
| Cellergy | CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEA. | Ratis, LLC | 2aebc11e-eeb7-436b-b90c-3a2f59fb7492 | 2023-08-07 | Warnings | 451W47IQ8X |
| Allergies | APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUM | Newton Laboratories, Inc. | 017f3bcf-0e45-d390-e063-6394a90a588e | 2023-07-28 | Warnings | 451W47IQ8X |
| Allergies | APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUM | Newton Laboratories, Inc. | 017f0210-195d-11d7-e063-6294a90aa750 | 2023-07-27 | Warnings | 451W47IQ8X |
| Melatonin Pro | CALCAREA CARBONICA, CHAMOMILLA, COCCULUS INDICUS, COFFEA CRUDA, FERRUM PHOSPHORICUM, KALI PHOSPHORICUM, MAGNESIA CARBONICA, MELATONIN, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (PRATENSIS) | Energique, Inc. | 1f374642-83f7-4e64-b330-0f6ef21000a9 | 2023-07-19 | Warnings | 451W47IQ8X |
| Gum Therapy | CALENDULA OFFICINALIS, KALI PHOSPHORICUM, NATRUM MURIATICUM, ARNICA MONTANA, AGAVE AMERICANA, CISTUS CANADENSIS, KREOSOTUM, MYRRHA, CALCAREA FLUORICA, ACONITUM NAPELLUS, BISMUTHUM SUBNITRICUM, SEPIA, HEPAR SULPHURIS CALCAREUM, MERCURIUS VIVUS | Deseret Biologicals | 0cf8a815-808d-4018-baf9-2b4545fc7ea8 | 2023-07-19 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | b6e33138-841a-471f-a934-c4086cbc23f6 | 2023-07-17 | Warnings, Adverse reactions | 451W47IQ8X |
| Anpituapar | HYPOPHYSIS SUIS, AGNUS CASTUS, BARYTA CARBONICA, CALCAREA CARBONICA, IODIUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, SEPIA, THYROIDINUM (SUIS), LAC CANINUM, ADRENOCORTICOTROPHIN | Energique, Inc. | c0ed2996-8eb5-43f7-b3cc-17477af7f7e9 | 2023-07-13 | Warnings | 451W47IQ8X |
| Pneumotox | TRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM, | BioActive Nutritional, Inc. | f8846fb1-92e5-4f8e-b3b3-bc620df90a62 | 2023-07-12 | Warnings | 451W47IQ8X |
| Thyrostat | FUCUS VESICULOSUS, SPONGIA TOSTA, HYPOPHYSIS SUIS, THYROIDINUM (SUIS), ARSENICUM IODATUM, BARYTA CARBONICA, IODIUM, LYCOPUS VIRGINICUS, NATRUM MURIATICUM | Energique, Inc. | 5c41b36c-e28f-4d60-b9b9-6b888d55ea95 | 2023-07-12 | Warnings | 451W47IQ8X |
| Introvert Formula | PASSIFLORA INCARNATA, PULSATILLA (PRATENSIS), IGNATIA AMARA, NATRUM MURIATICUM, DUODENUM (SUIS), PETROLEUM, SULPHUR | Nutritional Specialties, Inc. | 522148c9-0bc0-44c9-8876-70051224c951 | 2023-07-11 | Warnings | 451W47IQ8X |
| Hypercalm-Mental Focus | CHAMOMILLA, ECHINACEA, HYPERICUM PERFORATUM, PASSIFLORA INCARNATA, ACONITUM NAPELLUS, ADRENALINUM, ARGENTUM NIT., ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, DIGITALIS PURPUREA, GELSEMIUM SEMPERVIRENS, HUMULUS LUPULUS, HYOSCYAMUS NIGER, IGNATIA AMARA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SCUTELLARIA LATERIFLORA, STAPHYSAGRIA, STRAMONIUM, THERIDION, VERATRUM VIRIDE | Newton Laboratories, Inc. | ff5f22e1-74ee-1eee-e053-6394a90a2678 | 2023-06-30 | Warnings | 451W47IQ8X |
| Hypercalm-Mental Focus | CHAMOMILLA, ECHINACEA, HYPERICUM PERFORATUM, PASSIFLORA INCARNATA, ACONITUM NAPELLUS, ADRENALINUM, ARGENTUM NIT., ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, DIGITALIS PURPUREA, GELSEMIUM SEMPERVIRENS, HUMULUS LUPULUS, HYOSCYAMUS NIGER, IGNATIA AMARA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SCUTELLARIA LATERIFLORA, STAPHYSAGRIA, STRAMONIUM, THERIDION, VERATRUM VIRIDE | Newton Laboratories, Inc. | ff604442-4697-e2bb-e053-6394a90a0340 | 2023-06-30 | Warnings | 451W47IQ8X |
| Natrum muriaticum | SODIUM CHLORIDE | Boiron | 86455058-2722-5c0a-e053-2a91aa0ac659 | 2023-06-26 | 451W47IQ8X | |
| Hyperactivity-Mental Focus | ADRENALINUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, CHAMOMILLA, CYPRIPEDIUM, DIGITALIS, GELSEMIUM, HUMULUS, IGNATIA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS, LYCOPODIUM, NAT. MUR., NUX VOM., SCUTELLARIA LATERIFLORA, STAPHYSAG., STRAMONIUM, THERIDION, ECHINACEA, GINGKO, HYPERICUM, PASSIFLORA | Newton Laboratories, Inc. | fecece1f-22bc-21dc-e053-6294a90ad0c3 | 2023-06-23 | Warnings | 451W47IQ8X |
| Hyperactivity-Mental Focus | ADRENALINUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, CHAMOMILLA, CYPRIPEDIUM, DIGITALIS, GELSEMIUM, HUMULUS, IGNATIA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS, LYCOPODIUM, NAT. MUR., NUX VOM., SCUTELLARIA LATERIFLORA, STAPHYSAG., STRAMONIUM, THERIDION, ECHINACEA, GINGKO, HYPERICUM, PASSIFLORA | Newton Laboratories, Inc. | fed03a1c-0ea8-1f8e-e053-6394a90a04c0 | 2023-06-23 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.