NDC 68516-3205 - 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
- 68516-3205
- Package NDCs from labels
- 68516-3205-2
- 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 |
|---|---|---|---|---|---|---|
| 68516-3205-2 | Profilnine | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 mL | 1000 [iU] in 10mL | 33 |
| 68516-3205-2 | Profilnine | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 mL | 1000 [iU] in 10mL | 33 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68516-3205 | 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 |
|---|---|---|---|---|---|---|
| SODIUM CHLORIDE | SODIUM CHLORIDE | Baxter Healthcare Corporation | 123bd10a-90c7-499e-97f6-acf7e0f0fb4e | 2022-07-29 | Warnings, Adverse reactions | 451W47IQ8X |
| Herplex | ANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIA | Nashco Products LLC | fad9615f-7004-415d-9f69-ee9ff95f0067 | 2022-07-12 | Warnings | 451W47IQ8X |
| BHI Constipation | DIOSCOREA VILLOSA TUBER, SODIUM CHLORIDE, AND STRYCHNOS NUX-VOMICA SEED | MediNatura Inc | 0365b75b-fee4-4c1d-89ab-c692bdd73f75 | 2022-07-07 | Warnings | 451W47IQ8X |
| Natrium Muriaticum 6X | SODIUM CHLORIDE | Seroyal USA | 0ebf18de-12fe-0bc4-e054-00144ff88e88 | 2022-07-07 | Warnings | 451W47IQ8X |
| Erogetone | ARALIA QUINQUEFOLIA, BERBERIS VULGARIS, CAUSTICUM, CONIUM MACULATUM, DAMIANA, GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIA | Energique, Inc. | 1e872ecd-e7a5-463d-9832-47b7046096db | 2022-06-28 | Warnings | 451W47IQ8X |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | f42ac50f-0ec5-4713-a4c8-99d972d90bed | 2022-06-22 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | e71c6c83-d518-496c-b2ab-efd5987e4783 | 2022-06-09 | Warnings, Adverse reactions | 059QF0KO0R |
| Cardioplegic Solution | POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDE | Fresenius Kabi, USA, LLC | eb360dc4-88d6-4b28-9b61-bc359e16bd22 | 2022-05-27 | Warnings, Adverse reactions | 451W47IQ8X |
| Addiclenz | BETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM | Deseret Biologicals, Inc. | e39235ea-2a2f-44a7-92d6-fb1d428ebabd | 2022-05-12 | Warnings | 1Q73Q2JULR |
| Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | 24a08a93-df23-474b-873e-c59ec8855f9f | 2022-03-14 | Warnings, Adverse reactions | 451W47IQ8X |
| Wild Horse 777 Moisturizing Nasal | SODIUM CHLORIDE | Wild Horse 777, Inc. | b0b4dadd-11fa-3dbb-e053-2995a90a2097 | 2022-03-14 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | cc14fafd-3dcd-4fc8-bdbd-6f355c375768 | 2022-02-23 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | 8b44bfd3-70a4-4b47-bc7b-590f63b8cc75 | 2022-02-15 | Warnings, Adverse reactions | 451W47IQ8X |
| ACNE HP | CARBO ANIMALIS, ACTIVATED CHARCOAL, POTASSIUM DICHROMATE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, SULFUR, ZINC | Natural Creations, Inc. | b2368ab6-e233-4473-99fa-86e1fbc2a879 | 2022-02-14 | Warnings | 451W47IQ8X |
| ACD-A | ANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA A | Fenwal, Inc. | 22805f0d-ba58-41ea-b245-19980abcda22 | 2022-02-11 | 1Q73Q2JULR | |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | f62481fd-fcdb-4be6-ac13-29c590e925c3 | 2022-02-10 | Adverse reactions | 451W47IQ8X |
| Sterile Water | WATER | American Regent, Inc. | 78b35864-4bbc-4759-a5c1-7e4f25e22932 | 2022-01-31 | Boxed warning | 059QF0KO0R |
| Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | e44c41ae-c9c8-4dd8-ba6c-cebb585378aa | 2022-01-31 | Warnings, Adverse reactions | 451W47IQ8X |
| Sterile Saline Mist Walgreens | SODIUM CHLORIDE | WALGREEN COMPANY | d6b9d4fc-b758-be32-e053-2995a90a2523 | 2022-01-29 | Warnings | 451W47IQ8X |
| Extra Strenght Saline Mist Rite Aid | SODIUM CHLORIDE | RITE AID CORPORATION | d5b30fb2-4052-4a0c-e053-2a95a90aacd5 | 2022-01-16 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.