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 |
|---|---|---|---|---|---|---|
| PSORIASIS | ARSENICUM ALBUM, ARSENICUM IODATUM, BORAX, CALCAREA CARBONICA, GRAPHITES, MEZEREUM, PROTEUS, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, SEPIA, SILICEA, SULPHUR, THYROIDINUM | Zorex International | b5b8bb82-4d36-4faa-b023-e48066f4521c | 2023-01-09 | Warnings | 451W47IQ8X |
| Virimmune | ALLIUM SATIVUM, ECHINACEA (ANGUSTIFOLIA), GINKGO BILOBA, VISCUM ALBUM, HAMAMELIS VIRGINIANA, ACONITUM NAPELLUS, ALLIUM CEPA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHELIDONIUM MAJUS, GELSEMIUM SEMPERVIRENS, MERCURIUS VIVUS, NATRUM MURIATICUM, NUX VOMICA, SELENIUM METALLICUM, INFLUENZINUM (2021-2022), MORBILLINUM | Deseret Biologicals, Inc. | 56555cb5-89e5-4a30-8ebe-ce2c01bdd426 | 2023-01-03 | Warnings | 451W47IQ8X |
| AILGENO | AMANITA MUSCARIA FRUITING BODY, ARSENIC TRIOXIDE, MILK THISTLE, CEANOTHUS AMERICANUS LEAF, CINCHONA OFFICINALIS BARK, GLECHOMA HEDERACEA FLOWERING TOP, GRINDELIA HIRSUTULA WHOLE, AND SODIUM CHLORIDE | PEKANA Naturheilmittel GmbH | 4e24f727-4c83-46b6-9549-8f66bd135647 | 2022-12-21 | Warnings | 451W47IQ8X |
| Weight Management HP | ARSENIC TRIOXIDE, GOLD, OYSTER SHELL CALCIUM CARBONATE, CRUDE, IODINE, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORIC ACID, PHOSPHORUS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SULFUR | Natural Creations, Inc. | 93736f0b-a419-4b90-84b0-f27e4c71299b | 2022-12-20 | Warnings | 451W47IQ8X |
| SODIUM CHLORIDE | SODIUM CHLORIDE | Liebel-Flarsheim Company LLC | e4540d03-06b4-4b4d-b859-75c13e5c20dd | 2022-12-20 | Warnings, Adverse reactions | 451W47IQ8X |
| FERRUM PHOSPHATE | SODIUM PHOSPHATE | Hyland's Inc. | c114cbad-11ed-4b1c-8ee0-33327c0e1718 | 2022-12-19 | Warnings | SE337SVY37 |
| NATRUM MURIATICUM | SODIUM CHLORIDE | Hyland's Inc. | 21ee53eb-b41a-4d2e-8037-12973d2b73d9 | 2022-12-19 | Warnings | 451W47IQ8X |
| Cataracc | ARSENICUM ALB., BRYONIA, CALC. FLUOR., CALENDULA, CAUSTICUM, CONIUM, EUPHRASIA, HYDROFLUORICUM AC., IODIUM, LEDUM, NAPHTHALINUM, NAT. MUR., NUX VOM., PHOS., PULSATILLA, SEPIA, SILICEA, TELLURIUM, THIOSINAMINUM, ZINC. MET. | Newton Laboratories, Inc. | eff981fd-5436-7c34-e053-2a95a90a3e8e | 2022-12-16 | Warnings | 451W47IQ8X |
| CVS Health Sterile Saline Mist | SODIUM CHLORIDE | CVS Pharmacy | 4df47f14-8268-4cd3-b29e-96446743e2f6 | 2022-12-16 | Warnings | 451W47IQ8X |
| Cold and Cough | ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEAL | Wal-Mart Stores, Inc. | 69349b4d-6c5b-7121-e053-2991aa0a3594 | 2022-12-15 | Warnings | 451W47IQ8X |
| Childrens Cold and Cough Nighttime | ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, ANEMONE PULSATILLA, ARABICA COFFEE BEAN, MATRICARIA CHAMOMILLA, SULFUR, PHOSPHORUS AND GOLDENSEAL | Walgreen Company | 80c41b65-0411-4395-e053-2a91aa0a9df9 | 2022-12-15 | Warnings | 451W47IQ8X |
| Childrens Cold and Cough | ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEAL | Walgreen Company | 80b5f707-a839-7729-e053-2991aa0a1c56 | 2022-12-15 | Warnings | 451W47IQ8X |
| FERRODONNA | ARSENIC TRIOXIDE, CEANOTHUS AMERICANUS LEAF, CINCHONA OFFICINALIS BARK, COBALTOUS NITRATE, CUPRIC SULFATE, IRON, MANGANESE ACETATE, AND SODIUM CHLORIDE | PEKANA Naturheilmittel GmbH | 64c6f75a-382d-4aa0-b210-6be83a62fa3f | 2022-12-14 | Warnings | 451W47IQ8X |
| Nat Mur | SODIUM CHLORIDE | Hyland's Inc. | d3ab4254-daaf-24ac-e053-2995a90afb8f | 2022-12-13 | Warnings | 451W47IQ8X |
| NERVE TONIC STRESS RELIEF | CALCIUM PHOSPHATE, IRON, POTASSIUM PHOSPHATE, UNSPECIFIED FORM, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, AND SODIUM PHOSPHATE | Hyland's Inc. | ec5a66df-a66c-4cdd-9685-af0a79b47bb8 | 2022-12-13 | Warnings | SE337SVY37 |
| Rest | SILVER NITRATE,CAUSTICUM,MATRICARIA CHAMOMILLA,ANAMIRTA COCCULUS SEED,SODIUM CHLORIDE,PHOSPHORUS AND VALERIAN | Hyland's Inc. | 5e9924be-4dad-324a-e053-2a91aa0a8ec1 | 2022-12-13 | Warnings | 451W47IQ8X |
| Defend Cold and Mucus | BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PATENS, RUMEX CRISPUS ROOT, AND SILICON DIOXIDE | Hyland's Inc. | bb851be1-0528-4199-91e7-e09f994b2862 | 2022-12-12 | Warnings | 451W47IQ8X |
| BACTERIOSTATIC SODIUM CHLORIDE | BACTERIOSTATIC SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 7611e508-6da2-3a2f-e053-2a91aa0a9f40 | 2022-12-09 | Boxed warning, Warnings, Adverse reactions | 451W47IQ8X |
| BACTERIOSTATIC SODIUM CHLORIDE | BACTERIOSTATIC SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 763ff805-af1a-e8e9-e053-2a91aa0a8253 | 2022-12-09 | Boxed warning, Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Corporation | 2fae04e3-20b1-4b8c-b1fb-646b384836f1 | 2022-12-07 | Warnings, Adverse reactions | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.