NDC 66658-113-01 - KEPIVANCE
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
- 66658-113
- Requested NDC
- 66658-113-01
- Package NDCs from labels
- 66658-113-01, 66658-113-03
- Manufacturer
- Swedish Orphan Biovitrum AB (publ)
- Effective date
- 2025-12-17
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| KEPIVANCE - Swedish Orphan Biovitrum AB (publ) | Swedish Orphan Biovitrum AB (publ) | 2025-12-17 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66658-113-01 | KEPIVANCE | 1.2 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 1.2 | 22 | |
| 66658-113-03 | KEPIVANCE | 3 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 3 | 22 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| palifermin | ACTIVE INGREDIENT | QMS40680K6 | KEPIVANCE (PALIFERMIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)] | 10 | |
| palifermin | ACTIVE MOIETY | QMS40680K6 | KEPIVANCE (PALIFERMIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)] | 10 | |
| histidine | INACTIVE INGREDIENT | 4QD397987E | KEPIVANCE (PALIFERMIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)] | 10 | |
| mannitol | INACTIVE INGREDIENT | 3OWL53L36A | KEPIVANCE (PALIFERMIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)] | 10 | |
| polysorbate 20 | INACTIVE INGREDIENT | 7T1F30V5YH | KEPIVANCE (PALIFERMIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)] | 10 | |
| sucrose | INACTIVE INGREDIENT | C151H8M554 | KEPIVANCE (PALIFERMIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)] | 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 |
|---|---|---|---|---|---|---|
| Aminosyn II | ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, AND GLYCINE | ICU Medical Inc. | 5b426208-f090-4650-86c3-89040ba45c2d | 2025-11-02 | Boxed warning, Warnings, Adverse reactions | 4QD397987E |
| Sorbitol-Mannitol | SORBITOL AND MANNITOL | ICU Medical Inc. | 5b44e248-4b7b-4777-954a-921c7b309944 | 2025-10-30 | Warnings, Adverse reactions | 3OWL53L36A |
| Mannitol | MANNITOL | ICU Medical Inc. | ba7bf864-8a4d-4262-8fd1-00174fa2f9d1 | 2025-10-24 | Warnings, Adverse reactions | 3OWL53L36A |
| Sugar Cravings | CINNAMIC ACID, PHLORIDZINUM, ARGENTUM NITRICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, BEET SUGAR, DEXTROSE, D-RIBOSE, FRUCTOSE, LYCOPODIUM CLAVATUM, MAPLE SUGAR, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, MALVIN, ADRENOCORTICOTROPHIN, DYSENTERY BACILLUS, MORGAN GAERTNER | Dr. Donna Restivo DC | 401873ba-ae1b-4506-a2e8-c6c0e5ff27f5 | 2025-10-21 | Warnings | C151H8M554 |
| Aminosyn-PF | ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, AND TYROSINE | ICU Medical Inc. | 2d212e10-7e08-4aeb-b63f-dcc927897769 | 2025-10-17 | Warnings, Adverse reactions | 4QD397987E |
| Aminosyn-PF | ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, AND TYROSINE | ICU Medical Inc. | 46e74ce4-cd7e-437f-bf54-ca9b98eb2663 | 2025-10-10 | Boxed warning, Warnings, Adverse reactions | 4QD397987E |
| Perikabiven | DEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINE | Fresenius Kabi USA, LLC | c2eb5522-8572-45f4-869d-42f9fd251bb6 | 2025-09-15 | Warnings, Adverse reactions | 4QD397987E |
| Kabiven | DEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINE | Fresenius Kabi USA, LLC | afeb4837-a759-4484-a76e-e04611c459e7 | 2025-09-11 | Warnings, Adverse reactions | 4QD397987E |
| Osmitrol | MANNITOL | Baxter Healthcare Company | 0d914965-7001-45cb-ba51-d7c5964b05bc | 2025-08-26 | Warnings, Adverse reactions | 3OWL53L36A |
| Aller-Chord F | ACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE. | Energetix Corporation | ff4eb7b2-8272-4bd3-99a9-7e589b30d59a | 2025-07-15 | Warnings | C151H8M554 |
| Intimate | ANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA (HUMAN), GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALIS | Deseret Biologicals, Inc. | 066bd402-378b-48aa-9515-188c261a3f4c | 2025-05-27 | Warnings | C151H8M554 |
| Mannitol | MANNITOL | Henry Schein, Inc. | e2444db1-9dfe-451f-a33c-9b00786464d2 | 2025-05-20 | Warnings, Adverse reactions | 3OWL53L36A |
| Shame | ADRENALINUM, AGNUS CASTUS, ALOE, AMBRA GRISEA, AURUM MURIATICUM NATRONATUM, BARYTA CARBONICA, CALCAREA IODATA, CANDIDA ALBICANS, CEREBRUM SUIS, CINCHONA OFFICINALIS, DIGITALIS PURPUREA, HYPOTHALAMUS SUIS, IGNATIA AMARA, LAC DEFLORATUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, RHUS GLABRA, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), STAPHYSAGRIA, THUJA OCCIDENTALIS | Deseret Biologicals, Inc. | 090e4a23-3e1b-4b0c-a0cc-0172b05f7b64 | 2025-05-07 | Warnings | C151H8M554 |
| Alcostat | TARAXACUM OFFICINALE, AVENA SATIVA, PASSIFLORA INCARNATA, AURUM METALLICUM, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NOX VOMICA, QUERCUS GLANDIUM SPIRITUS, SULPHURICUM ACIDUM, ETHYLICUM, CARCINOSIN, SACCHARUM OFFICINALE | Energique, Inc. | 77daea02-3c32-4ba3-a7a8-af79b13ddc06 | 2025-02-27 | Warnings | C151H8M554 |
| Anise Pyrite | ANISE PYRITE | Uriel Pharmacy Inc. | a03cdeb0-8347-40cc-8d17-5510d99575c7 | 2025-01-22 | Warnings | C151H8M554 |
| A-5 | SUCROSE | DNA Labs, Inc. | 8e63f697-26c1-4518-acd3-5ea72cfa27f7 | 2025-01-09 | Warnings | C151H8M554 |
| Gut Brain Spectrum | ABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PROPIONIC ACID, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUM | Energique, Inc. | adfee6ce-05b0-4955-bf5f-9612b8db4c78 | 2024-12-26 | Warnings | C151H8M554 |
| Focus | ADENOSINUM CYCLOPHOSPHORICUM, ADRENALINUM, AETHUSA CYNAPIUM, ALPHA-KETOGLUTARICUM ACIDUM, AMBRA GRISEA, BARYTA CARBONICA, CANDIDA ALBICANS, CARBONEUM SULPHURATUM, CEREBRUM SUIS, GINKGO BILOBA, HELLEBORUS NIGER, HYPOTHALAMUS SUIS, HYOSCYAMUS NIGER, IODIUM, PHOSPHORUS, SACCHARUM OFFICINALE, SARCOLACTICUM ACID, SILICEA, TARENTULA HISPANA, VERATRUM ALBUM | Deseret Biologicals, Inc. | e014e6b6-a07a-4170-b9af-f477da71597d | 2024-11-13 | Warnings | C151H8M554 |
| Lactistat | ARSENICUM ALBUM, CALCAREA CARBONICA, COCCULUS INDICUS, GRAPHITES, HYDROFLUORICUM ACIDUM, LACHESIS MUTUS, LACTICUM ACIDUM, RHUS TOX, RUTA GRAVEOLENS, SARCOLACTICUM ACIDUM, SACCHARUM OFFICINALE | Energique, Inc. | 8dcc4a3a-9f21-4a77-ae42-b2c8283a076a | 2024-10-28 | Warnings | C151H8M554 |
| Grain and Seed Antigens | BAMBOO, BARLEY, CORN, COTTON SEED, FLAX SEED (LINUM USITATISSIMUM), MILLET, MILO, OAT, POPPY SEED, RICE, RYE, SAFFLOWER, SESAME, SORGHUM, SOY BEAN, SUGARCANE, SUNFLOWER (HELIANTHUS ANNUUS), WHEAT, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHUR | Energique, Inc. | a028eaea-76ef-45db-80e1-d7b4a0655d5e | 2024-10-25 | Warnings | C151H8M554 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.