NDC 63833-396 - Kcentra
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
- 63833-396
- Package NDCs from labels
- 63833-396-01
- Manufacturer
- CSL Behring GmbH | CSL Behring LLC
- Effective date
- 2023-05-16
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Kcentra - CSL Behring GmbH | CSL Behring LLC | CSL Behring GmbH | CSL Behring LLC | 2023-05-16 | PLASMA DERIVATIVE |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63833-396-01 | Kcentra | 20 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 20 mL | 460 U in 20mL | 13 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63833-396 | KCENTRA (PROTHROMBIN, COAGULATION FACTOR VII HUMAN, COAGULATION FACTOR IX HUMAN, COAGULATION FACTOR X HUMAN, PROTEIN C, PROTEIN S HUMAN, AND WATER) KIT [CSL BEHRING GMBH] | 13 | Unmatched | 20230517_eee1afb8-324c-42e4-8bf0-f0c9da5e6d42.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 |
|---|---|---|---|---|---|---|
| ACNE HP | CARBO ANIMALIS, ACTIVATED CHARCOAL, POTASSIUM DICHROMATE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, SULFUR, ZINC | Natural Creations, Inc. | b2368ab6-e233-4473-99fa-86e1fbc2a879 | 2022-02-14 | Warnings | 451W47IQ8X |
| ACD-A | ANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA A | Fenwal, Inc. | 22805f0d-ba58-41ea-b245-19980abcda22 | 2022-02-11 | 1Q73Q2JULR | |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | f62481fd-fcdb-4be6-ac13-29c590e925c3 | 2022-02-10 | Adverse reactions | 451W47IQ8X |
| Sterile Water | WATER | American Regent, Inc. | 78b35864-4bbc-4759-a5c1-7e4f25e22932 | 2022-01-31 | Boxed warning | 059QF0KO0R |
| Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | e44c41ae-c9c8-4dd8-ba6c-cebb585378aa | 2022-01-31 | Warnings, Adverse reactions | 451W47IQ8X |
| Sterile Saline Mist Walgreens | SODIUM CHLORIDE | WALGREEN COMPANY | d6b9d4fc-b758-be32-e053-2995a90a2523 | 2022-01-29 | Warnings | 451W47IQ8X |
| Extra Strenght Saline Mist Rite Aid | SODIUM CHLORIDE | RITE AID CORPORATION | d5b30fb2-4052-4a0c-e053-2a95a90aacd5 | 2022-01-16 | Warnings | 451W47IQ8X |
| Sterile Saline Mist Rite Aid | SODIUM CHLORIDE | RITE AID | d583067e-1133-7d7d-e053-2a95a90a1e36 | 2022-01-13 | Warnings | 451W47IQ8X |
| SinuCleanse Sterile Saline Mist | SODIUM CHLORIDE | ASCENT CONSUMER PRODUCTS, INC | 648da2bc-bc91-4295-9e46-d3055cdc2418 | 2022-01-08 | Warnings | 451W47IQ8X |
| SinuCleanse Nasal Drip | SODIUM CHLORIDE | ASCENT CONSUMER PRODUCTS, INC | d5129a91-50e7-6b94-e053-2a95a90a2b30 | 2022-01-08 | Warnings | 451W47IQ8X |
| SinuCleanse Sterile Saline Mist Daily Care | SODIUM CHLORIDE | ASCENT CONSUMER PRODUCTS, INC | d5131ab2-8213-3659-e053-2a95a90ab2ab | 2022-01-08 | Warnings | 451W47IQ8X |
| BHI Hemorrhoid | HORSE CHESTNUT, ALOE, COLLINSONIA CANADENSIS ROOT, VERONICASTRUM VIRGINICUM ROOT, HYDROCHLORIC ACID, STRYCHNOS NUX-VOMICA SEED, PAEONIA OFFICINALIS ROOT, AND SULFUR | MediNatura Inc | d7df7d3e-48ad-4f58-aef5-a7bd48d2f191 | 2022-01-05 | Warnings | QTT17582CB |
| Headek Nasal | BELLADONNA, GLONOINUM, COFFEA, NATRUM CARB, NATRUM MUR. | Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics | 976b9c85-68c9-46a5-9012-53cb24683b03 | 2021-12-29 | Warnings | 451W47IQ8X |
| EAR RX | ACONITUM NAP, BARYTA CARB, BELLADONNA, CALC CARB, CAPSICUM, CARBO VEG, CAUSTICUM, CHAMOMILLA, FERRUM PHOS, HEPAR SULPH CALC, KALI MUR, LACHESIS, LYCOPODIUM, MERCURIUS SOL, NATRUM MUR, PLANTAGO, PULSATILLA, SILICEA, SULPHUR, VERBASCUM | Miami Beach Pediatrics pa | a8753f88-4b8a-472f-a4bd-f2e9cec83610 | 2021-12-29 | Warnings | 451W47IQ8X |
| Joette Calabrese Survivalist Kit | ABROT ACON AGN AIL AMBR AMBRO AM-C ANT-C APIS ARN ARS AUR-A AUR BAPT BAR-C BELL BB BOTH BOV BROM CADM-S CALAD CALC CAMPH CARB-AC CARD-M CEAN CHEL CHININ-A CINA CHIN CIC COB COLCH CON CROT-H CROT-T CUPR DULC ELAPS EUP-PER FL-AC GALPH GRAPH GUNP HAM HEKLA HELL HEP HYDR-AC HYOS HYPER KALI-BR KALI-C KALI-I LATH LAUR LED LOB MERC-CY MERC MEZ MOSCH MUR-AC NAJA NAT-C NIT-AC NUX-M PYROG PH-AC PIC-AC PLB RHUS-T RUTA SAMB SANG SARR SEP STRAM SUL-AC TAB TERENT TER TEUCR VERAT VERAT-V VIP | OHM PHARMA INC. | 1ac2a2c4-704e-4efa-aa44-acc71d300f70 | 2021-12-29 | Warnings | QTT17582CB |
| Lyme Disease Support 1 | ALUMEN, CALCAREA CARBONICA, DNA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI CARBONICUM, KALI MURIATICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, RNA, SILICEA. | OHM PHARMA INC. | 035e75d6-aeef-4dfd-b076-9d3d8e4a5086 | 2021-12-29 | Warnings | 451W47IQ8X |
| Anxiety Stress Relief | ARG NIT, AUR MET, AVENA, GELSEMIUM, HYOSCYAMUS, IGNATIA, MOSCHUS, NAT MUR, PASSIFLORA, STANNUM MET, VALERIANA. | OHM PHARMA INC. | b736ec93-199a-4d19-882a-186c0e2adb11 | 2021-12-29 | Warnings | 451W47IQ8X |
| TH-101 | CALC CARB, CARBO VEG, CHELIDONIUM MAJ, COQ10, FUCUS, GRAPHITES, HOMEOPATHIC GLYCOPROTEIN COMPLEX, HYPOTHALAMUS, KALI PHOS, LYCOPODIUM, MAG PHOS, NAT MUR, NAT PHOS, NUX VOM, ORNITHOGALUM, PHYTOLACCA, PITUITARUM, PLACENTA, SINAPIS ARV FLOS, QUERCUS GLAND SP, QUERCUS ROB | Temple Health Nutrition, LLC | d54bb860-560c-4f8f-9aea-a0b7774cc92b | 2021-12-29 | Warnings | 451W47IQ8X |
| Sterile Diluent for Treprostinil | WATER | Dr.Reddy's Laboratories Inc., | 33050ee2-519b-1f0b-d4df-9e14dd329c57 | 2021-12-23 | Warnings, Adverse reactions | 059QF0KO0R |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | 4829ee40-c2d7-4e17-a606-75e8a8628413 | 2021-12-21 | Warnings, Adverse reactions | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.