NDC 68516-3605-2 - AlphaNine SD
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
- 68516-3605
- Requested NDC
- 68516-3605-2
- Package NDCs from labels
- 68516-3605-2
- Manufacturer
- GRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SA
- Effective date
- 2025-05-27
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| dextrose - GRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SA | GRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SA | 2025-05-27 | PLASMA DERIVATIVE |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68516-3605-2 | AlphaNine SD | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 mL | 1000 [iU] in 10mL | 25 |
| 68516-3605-2 | AlphaNine SD | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 mL | 1000 [iU] in 10mL | 25 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68516-3605 | ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC] | 24 | Unmatched | 20240123_3e99052d-4442-4283-8915-c9a796c77008.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| COAGULATION FACTOR IX HUMAN | ACTIVE INGREDIENT | 6U90Y1795T | ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC] | 10 | |
| Coagulation Factor IX Human | ACTIVE MOIETY | 6U90Y1795T | ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC] | 10 | |
| dextrose | INACTIVE INGREDIENT | IY9XDZ35W2 | ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC] | 10 | |
| heparin | INACTIVE INGREDIENT | T2410KM04A | ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC] | 10 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC] | 10 | |
| sodium citrate | INACTIVE INGREDIENT | 1Q73Q2JULR | ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC] | 10 |
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 |
|---|---|---|---|---|---|---|
| Walgreens Saline Mist Extra Strength | SODIUM CHLORIDE | Walgreen's Corporation | 90cbe2dc-36b6-77fb-e053-2995a90a2897 | 2024-12-18 | Warnings | 451W47IQ8X |
| 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 |
| Dextrose | DEXTROSE | B. Braun Medical Inc. | 8ccb10fe-75a5-440b-8cd4-b11f4e98f7b0 | 2024-12-06 | Warnings, Adverse reactions | IY9XDZ35W2 |
| 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 |
| 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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.