NDC 68516-3206 - 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
- 68516-3206
- Package NDCs from labels
- 68516-3206-2
- 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 |
|---|---|---|---|---|---|---|
| 68516-3206-2 | Profilnine | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 mL | 1500 [iU] in 10mL | 33 |
| 68516-3206-2 | Profilnine | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 mL | 1500 [iU] in 10mL | 33 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68516-3206 | 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 |
|---|---|---|---|---|---|---|
| CVS Health Sterile Saline Mist | SODIUM CHLORIDE | CVS Pharmacy | 6f1fe980-ca09-401d-aed6-d3d3387cc49a | 2024-12-18 | Warnings | 451W47IQ8X |
| Mast Cell Pro | HYDRASTIS CANADENSIS, ASCORBICUM ACIDUM, CINCHONA OFFICINALIS, KIDNEY (SUIS), THIAMINUM HYDROCHLORICUM, URTICA DIOICA, APIS MELLIFICA, ARSENICUM ALBUM, BOVISTA, CARBOLICUM ACIDUM, COFFEA CRUDA, HISTAMINUM HYDROCHLORICUM, LACHESIS MUTUS, LEDUM PALUSTRE, NUX VOMICA, OXALICUM ACIDUM, PHOSPHORUS, RHUS TOX, SARCOLACTICUM ACIDUM, SECALE CORNUTUM, SEPIA, SEROTONIN (HYDROCHLORIDE), SULPHUR, THUJA OCCIDENTALIS, VENUS MERCENARIA, ACONITUM NAPELLUS, CALADIUM SEGUINUM, IGNATIA AMARA, NATRUM MURIATICUM, | Energique, Inc. | 5cd31e1d-0312-48d1-9ecd-d01c6fe3b672 | 2024-12-11 | Warnings | 451W47IQ8X |
| Fendall Pure Flow | PURIFIED WATER | Honeywell Safety Products USA, Inc. | afda6fc3-7615-b0be-e053-2995a90a6208 | 2024-12-10 | Warnings | 059QF0KO0R |
| Junior Moves | ANACARDIUM, BRYONIA, MAG MUR, NAT MUR, PLUMB MET | Silver Star Brands | 822d5481-7854-3fe7-e053-2a91aa0abf55 | 2024-12-03 | Warnings | 451W47IQ8X |
| Migo-Ease | ACONITUM NAP, LYCOPODIUM, NAT MUR, NUX VOM, PULSATILLA | Silver Star Brands | 816837f5-4487-657d-e053-2991aa0a78f4 | 2024-12-03 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Company | 464c2d78-5c88-4668-a039-56dd3c1c9b20 | 2024-12-03 | 451W47IQ8X | |
| XX Health Pro | LACHESIS, NAT MUR, PULSATILLA, SEPIA, SULPHUR | Silver Star Brands | 4d11a65e-696a-0727-e054-00144ff88e88 | 2024-12-02 | Warnings | 451W47IQ8X |
| Para-Si | JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER | Newton Laboratories, Inc. | 27d41602-9dcb-eaa8-e063-6394a90a7cfa | 2024-11-26 | Warnings | 451W47IQ8X |
| Para-Si | JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHEIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER | Newton Laboratories, Inc. | 27d4ddaf-9c07-a7fc-e063-6394a90adc0b | 2024-11-26 | Warnings | 451W47IQ8X |
| Para-Si | JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER | Newton Laboratories, Inc. | 27d5997b-1cae-41c2-e063-6394a90ac74a | 2024-11-26 | Warnings | 451W47IQ8X |
| PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3% | PURIFIED WATER 98.3% | Acme United Corporation | 9248ee71-2d47-620d-e053-2995a90af5c8 | 2024-11-26 | Warnings | 059QF0KO0R |
| PhysiciansCare Ophthalmic Solution Eyewash | PURIFIED WATER 98.3% | Acme United Corporation | cca454e0-b2bd-4215-bc06-426fcc3f7bd6 | 2024-11-26 | Warnings | 059QF0KO0R |
| PhysiciansCare Ophthalmic Solution Eyewash | PURIFIED WATER 98.3% | Acme United Corporation | d3812fa3-9334-464d-b50c-98548ff76727 | 2024-11-26 | Warnings | 059QF0KO0R |
| DANGTTEOL | MINERAL WATER | AQBC CO., LTD | 27db14a9-3812-433f-e063-6394a90a11e7 | 2024-11-26 | Warnings | 059QF0KO0R |
| ReHydration | ADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUM | Energetix Corporation | 37063a49-6b45-4167-875d-49c9dac3f79b | 2024-11-20 | Warnings | 451W47IQ8X |
| TRICITRATES | POTASSIUM CITRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATE | PAI Holdings, LLC dba PAI Pharma | 2ecb42a2-82f1-456b-8f1e-02c2d0a7b5ad | 2024-11-15 | Warnings, Adverse reactions | 1Q73Q2JULR |
| Sodium Citrate and Citric Acid | SODIUM CITRATE AND CITRIC ACID MONOHYDRATE | Pharmaceutical Associates, Inc. | 63201a61-6ac5-41ae-8b2d-ff0d3a8ddfd5 | 2024-11-13 | Adverse reactions | 1Q73Q2JULR |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Company | 99a15716-bbb9-4e33-a48d-20c58b81f392 | 2024-11-13 | 451W47IQ8X | |
| Itch Formula | ANTIPYRINUM, APIS MELLIFICA, CALENDULA OFFICINALIS, CANTHARIS, COPAIVA OFFICINALIS, CROTON TIGLIUM, GRAPHITES, HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, MEZEREUM, NATRUM MURIATICUM, PETROLEUM, RHUS VENENATA, STAPHYSAGRIA, SULPHUR, URTICA URENS | Deseret Biologicals, Inc. | 4dfb177b-bff3-4b6d-8fd9-cadd1df7812c | 2024-11-12 | Warnings | 451W47IQ8X |
| Plasma-Lyte 148 (pH 7.4) | SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE | Baxter Healthcare Corporation | fe935c8d-f42d-42e4-8665-0dc66829f231 | 2024-11-08 | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.