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 |
|---|---|---|---|---|---|---|
| Blues - Mood - Emotions | ANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGO | Newton Laboratories, Inc. | 79890e75-dfac-0262-e053-2a91aa0a5ce5 | 2020-11-24 | Warnings | 451W47IQ8X |
| Blues - Mood - Emotions | ANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGO | Newton Laboratories, Inc. | 798ab5a2-7464-8e9d-e053-2a91aa0acc98 | 2020-11-24 | Warnings | 451W47IQ8X |
| Cold Hands - Feet | HISTAMINUM HYDROCHLORICUM,THYROIDINUM, ACONITUM NAP., ARSENICUM ALB., BRYONIA, CACTUS, CALC. FLUOR., CEANOTHUS, CINCHONA, CONVALLARIA, DIGITALIS, GELSEMIUM, GLONOINUM, HYDROCOYLE, KALI CARB., LACHESIS, NAJA, NAT CARB., NAT MUR., NUX VOM., PHOSPHORUS, PULLSATILLA, RHUS TOXICODENDRON, STROPHANTHUS HISPIDUS, SULPHUR, ECHINACEA | Newton Laboratories, Inc. | 7a2b4f28-2128-a8b2-e053-2a91aa0a2402 | 2020-11-24 | Warnings | 451W47IQ8X |
| Lactated Ringers | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE | Asclemed USA, Inc. | afac6cc5-1ced-4639-b6f6-86f40ef5c30e | 2020-10-29 | Warnings, Adverse reactions | 451W47IQ8X |
| GUNA ALLERGY | ADRENALINUM - ALLIUM CEPA - AMMONIUM CARBONICUM - APIS MELLIFICA - ARGENTUM NITRICUM - ARSENICUM ALBUM - CUPRUM ACETICUM - GALPHIMIA GLAUCA - GLANDULA SUPRARENALIS SUIS - HISTAMINUM HYDROCHLORICUM - LUFFA OPERCULATA - MATRICARIA CHAMOMILLA - MUCOSA NASALIS SUIS - NATRUM MURIATICUM - SABADILLA - SCILLA MARITIMA - | Guna spa | ae6bd80d-2c70-1a3f-e053-2a95a90a2652 | 2020-10-23 | Warnings | 451W47IQ8X |
| InterSol | PLATELET ADDITIVE 3 | Fenwal, Inc. | a00c4a93-cde2-4753-81f7-0d6fee9fb690 | 2020-10-20 | Warnings, Adverse reactions | 451W47IQ8X |
| SODIUM CHLORIDE | SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | ac0fd44a-3f39-8d7e-e053-2995a90afeec | 2020-08-04 | Warnings, Adverse reactions | 451W47IQ8X |
| Bach Original Flower Remedies | WATER | Nelson Bach USA Limited | 09c76050-42c5-4403-865c-a1f6f668d9c0 | 2020-06-15 | Warnings | 059QF0KO0R |
| Cardioplegic | CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM CHLORIDE | Baxter Healthcare Corporation | 1fd50ce5-2799-4c26-81da-02cf0578dd9e | 2020-06-11 | Warnings, Adverse reactions | 451W47IQ8X |
| 0.9% SODIUM CHLORIDE | 0.9% SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | a62b71db-8ba2-6f6b-e053-2a95a90a29d1 | 2020-05-21 | Warnings, Adverse reactions | 451W47IQ8X |
| LACTATED RINGERS AND DEXTROSE | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE | HF Acquisition Co LLC, DBA HealthFirst | a62cf623-9b8a-37e0-e053-2995a90add5b | 2020-05-21 | Warnings, Adverse reactions | 451W47IQ8X |
| Hay Fever | APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, ALFALFA, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, AMMONIUM CARBONICUM, ARALIA RACEMOSA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, BELLIS PERENNIS, BERBERIS VULGARIS, BRYONIA, CALLUNA VULGARIS, FLOS, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CISTUS CANADENSIS, DROSERA, DULCAMARA, EUPATORIUM PERFOLIATUM, EUPHRASIA OFFICINALIS, FAGUS SYLVATICA, FRAXINUS AMERICANA, GELSEMIUM SEMPERVIRENS | Newton Laboratories, Inc. | a6045b91-d361-2731-e053-2a95a90a9772 | 2020-05-18 | Warnings | 451W47IQ8X |
| Isolyte S | SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | B. Braun Medical Inc. | 7e8fe27f-ff82-48c1-9bf6-3c589c8e985d | 2020-05-14 | Warnings, Adverse reactions | 451W47IQ8X |
| DEXTROSE AND SODIUM CHLORIDE | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE | Fresenius Kabi USA, LLC | b825c9c4-f2fb-4a4a-9d8c-fb020ad07e93 | 2020-04-30 | Warnings, Adverse reactions | 451W47IQ8X |
| 0.9% SODIUM CHLORIDE | 0.9% SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | a2b8220f-e33a-51c3-e053-2995a90a0734 | 2020-04-07 | Warnings, Adverse reactions | 451W47IQ8X |
| 0.9% SODIUM CHLORIDE | 0.9% SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | a2bba76a-08ce-6902-e053-2995a90ab9c9 | 2020-04-07 | Warnings, Adverse reactions | 451W47IQ8X |
| Dextrose and Electrolyte No. 48 | SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, MONOBASIC POTASSIUM PHOSPHATE, SODIUM CHLORIDE AND DEXTROSE MONOHYDRATE | Baxter Healthcare Company | b283a454-0c20-4fbf-92d3-dae1f3cd3cad | 2020-02-13 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Corporation | fbc01464-8885-4075-af41-911ffec5ae92 | 2020-01-27 | Warnings, Adverse reactions | 451W47IQ8X |
| Sterile Water | WATER | Baxter Healthcare Company | 8bcf5572-49e1-4302-9522-56f57904cb4a | 2019-12-29 | Warnings, Adverse reactions | 059QF0KO0R |
| Plasma-Lyte A | SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDE | Baxter Healthcare Corporation | 6ec9e61c-2c26-402f-8604-f446b2e34058 | 2019-08-05 | Warnings, Adverse reactions | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.