NDC 68516-1002 - 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
- 68516-1002
- Package NDCs from labels
- 68516-1002-2
- 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 |
| dextrose - GRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SA | GRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SA | 2025-05-27 | PLASMA DERIVATIVE |
| Alphanate - GRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SA | GRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SA | 2025-05-22 | PLASMA DERIVATIVE |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68516-1002-2 | Profilnine | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 mL | 1 mL in 1mL | 33 |
| 68516-1002-2 | Profilnine | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 mL | 1 mL in 1mL | 33 |
| 68516-1002-2 | Alphanate | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 mL | 1 mL in 1mL | 26 |
| 68516-1002-2 | Alphanate | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 mL | 1 mL in 1mL | 26 |
| 68516-1002-2 | Alphanate | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 mL | 1 mL in 1mL | 26 |
| 68516-1002-2 | AlphaNine SD | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 mL | 1 mL in 1mL | 25 |
| 68516-1002-2 | AlphaNine SD | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 mL | 1 mL in 1mL | 25 |
| 68516-1002-2 | AlphaNine SD | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 mL | 1 mL in 1mL | 25 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68516-1002 | PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC] | 29 | Unmatched | 20230830_79821042-86a5-4a64-b621-76de0a0bbab2.zip |
| 68516-1002 | ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC] | 25 | Unmatched | 20231009_5a7aea94-654c-4113-9014-c3137de0a931.zip |
| 68516-1002 | ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC] | 24 | Unmatched | 20240123_3e99052d-4442-4283-8915-c9a796c77008.zip |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Anpitua Stim | ADRENOCORTICOTROPHIN, AGNUS CASTUS, BARYTA CARBONICA, CALCAREA CARBONICA, IODIUM, LAC CANINUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, SEPIA, THYROIDINUM SUIS, | J and Health DBA Wise Alternative | c96d09bc-eaf7-4977-8f22-68246839f37d | 2026-08-05 | Warnings | 451W47IQ8X |
| Metabatone | ARALIA RACEMOSA, AVENA SATIVA, BERBERIS VULGARIS, CAPSICUM ANNUUM, GINKGO BILOBA, PHYTOLACCA DECANDRA, HYPOTHALAMUS SUIS, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, FEL TAURI, HYALURONIDASE, PANCREAS SUIS, PANCREATINUM, PAPAIN, STOMACH (SUIS), L-ALANINE, L- ARGININE, L-CARNITINE, CYSTEINUM, L-GLUTAMINE, L-HISTIDINE, L-ISOLEUCINE, L-LEUCINE, L-LYSINE, L-METHIONINE, L-ORNITHINE, L-PROLINE, L-SERINE, L-TRYPTOPHAN, L-TYROSINE, L-VALINE, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, IODIUM, | Energique, Inc. | 9510bb76-b717-407d-b9e8-da7743e4cfc8 | 2026-07-31 | Warnings | 451W47IQ8X 4QD397987E 94ZLA3W45F |
| Garzulys | INSULIN ASPART-FSAN | Meitheal Pharmaceuticals Inc. | 30c64769-d2f7-4604-ac9e-2a6bc09506c9 | 2026-07-31 | Warnings, Adverse reactions | 059QF0KO0R |
| Bioplasma | SILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDE | Hyland's Inc. | dd0a7ed2-d112-4b96-e053-2995a90ac6b6 | 2026-07-30 | Warnings | 451W47IQ8X |
| Hypertonic Saline | SODIUM CHLORIDE | NAVEH PHARMA (1996) LTD | 167c7a9c-1228-4fb2-a89c-d3e148386323 | 2026-07-30 | Warnings | 451W47IQ8X |
| Hypertonic Saline Solution Sodium Chloride | SODIUM CHLORIDE | NAVEH PHARMA (1996) LTD | 750ea4b1-de2b-4299-aaa2-331daf383d0d | 2026-07-30 | Warnings | 451W47IQ8X |
| DECONIMO Reconstitution | DECONIMO RECONSTITUTION | Image Amazon LLC | 57ab9b1c-9a18-3786-e063-6394a90a2c63 | 2026-07-28 | Warnings | 059QF0KO0R |
| DELFLEX | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE | Fresenius Medical Care Renal Therapies Group, LLC | bbc5b820-4973-11e2-a192-0002a5d5c51b | 2026-07-27 | Warnings, Adverse reactions | 451W47IQ8X |
| DELFLEX | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE | Fresenius Medical Care Renal Therapies Group, LLC | c29bdfa0-4976-11e2-939b-0002a5d5c51b | 2026-07-27 | Warnings, Adverse reactions | 451W47IQ8X |
| Delflex | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE | Fresenius Medical Care de Mexico, S.A. de C.V. | a98facd6-9daa-4d37-8209-63a0599dbfaa | 2026-07-27 | Warnings, Adverse reactions | 451W47IQ8X |
| DELFLEX | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE | Fresenius Medical Care Renal Therapies Group, LLC | 515dcee0-3e34-11e2-a25f-0800200c9a66 | 2026-07-27 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Medical Care de Mexico, S.A. de C.V. | 9a1220fb-6853-45ae-838c-10d8596e1af7 | 2026-07-27 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Medical Care Renal Therapies Group, LLC | af5cdf1a-19f4-11e2-892e-0800200c9a66 | 2026-07-27 | Warnings, Adverse reactions | 451W47IQ8X |
| PEG 3350 and Electrolytes | POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE | A-S Medication Solutions | 19daf830-7270-4661-81b1-ded38f867f28 | 2026-07-24 | Warnings, Adverse reactions | 451W47IQ8X |
| Sterile Water | WATER | Cardinal Health 107, LLC | 9655cd02-82b5-4a75-813b-854b19551481 | 2026-07-21 | Warnings, Adverse reactions | 059QF0KO0R |
| Whisidom Saline Solution | SODIUM CHLORIDE 0.9% SALINE SOLUTION | Jiangxi Yudexi Pharmaceutical Co., LTD | 4e4e4169-2a14-3466-e063-6394a90a081b | 2026-07-20 | Warnings | 451W47IQ8X |
| Saline | NASAL | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 71485e82-bf54-4b8b-8dd2-2a0761534520 | 2026-07-17 | Warnings | 451W47IQ8X |
| Best Choice Anti Nausea Cherry Flavor | DEXTROSE(GLUCOSE),LEVULOSE(FRUCTOSE),PHOSPHORIC ACID | BEST CHOICE (VALU MERCHANDISERS COMPANY) | bc8b5208-2dbf-4636-8dd8-68c1ab975f57 | 2026-07-17 | Warnings | IY9XDZ35W2 |
| Sodium Chloride | SODIUM CHLORIDE | LABORATORIOS GRIFOLS SA | eb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf | 2026-07-15 | Warnings, Adverse reactions | 451W47IQ8X |
| Good Neighbor Anti Nausea Cherry Flavor | DEXTROSE(GLUCOSE),LEVULOSE(FRUCTOSE),PHOSPHORIC ACID | AMERISOURCE BERGEN | 82488773-3fef-41a0-afa7-e74ea19cd87d | 2026-07-13 | Warnings | IY9XDZ35W2 |