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 |
|---|---|---|---|---|---|---|
| Mannitol | MANNITOL | B. Braun Medical Inc. | d12cc802-b538-4065-a264-f474ff3b3043 | 2023-08-15 | Warnings, Adverse reactions | 3OWL53L36A |
| Allergies | APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUM | Newton Laboratories, Inc. | 017f3bcf-0e45-d390-e063-6394a90a588e | 2023-07-28 | Warnings | C151H8M554 |
| Allergies | APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUM | Newton Laboratories, Inc. | 017f0210-195d-11d7-e063-6294a90aa750 | 2023-07-27 | Warnings | C151H8M554 |
| Leaky Gut Formula | ALFALFA, GLYCYRRHIZA GLABRA, ASTACUS FLUVIATILIS, BERBERIS AQUIFOLIUM, LAC DEFLORATUM, NATRUM CARBONICUM, SACCHARUM OFFICINALE, ALOE, FEL TAURI, PANCREAS SUIS, PANCREATINUM, FRAGARIA VESCA, ANTIMONIUM CRUDUM, CARBO VEGETABILIS, EUPHORBIUM OFFICINARUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, ZINCUM METALLICUM, COLIBACILLINUM CUM NATRUM MURIATICUM, PROTEUS (VULGARIS) | Deseret Biologicals, Inc. | 8679e9ab-8610-47f1-be0e-66897f99881d | 2023-07-14 | Warnings | C151H8M554 |
| Grain and Seed Antigens | AMARANTH, BAMBOO, BARLEY, BUCKWHEAT, CORN, FLAX SEED, LENTILS, MILLET, MILO, OAT, POPPY SEED, RICE, RYE, SESAME, SOYBEAN, SUGARCANE, SUNFLOWER SEED, WHEAT, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHUR | BioActive Nutritional, Inc. | 36ce44a5-e5ac-4eea-b76d-424dcd4e6b07 | 2023-06-20 | Warnings | C151H8M554 |
| Vital Skin Hair Nails | 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, APIS MELLIFICA, BIOTIN, EPIDERMIS SUIS, GALIUM APARINE, HAMAMELIS VIRGINIANA, HEPAR SUIS, HGH, HYPOPHYSIS SUIS, NATRUM MURIATICUM, PANTOTHENIC ACID, PHOSPHORICUM ACIDUM, RIBOFLAVINUM, THUJA OCCIDENTALIS | Liddell Laboratories, Inc. | 3e8a9233-6e65-4023-b3f8-8bca369a9c2a | 2023-06-15 | Warnings | 4QD397987E |
| Mannitol | MANNITOL | Fresenius Kabi USA, LLC | c395e13d-6ea1-4104-8b37-669cfb982f04 | 2023-03-16 | Warnings, Adverse reactions | 3OWL53L36A |
| Saccharum officinale | SUCROSE | Boiron | 6858f374-8549-4b00-e053-2991aa0a5c3c | 2023-02-20 | C151H8M554 | |
| Saccharum Officinale | SACCHARUM OFFICINALE | Hahnemann Laboratories, INC. | f04b0ab3-af1c-ec2d-e053-2995a90a7855 | 2023-01-27 | C151H8M554 | |
| Chip Cravings | COUMARINUM, QUERCETIN, RUTIN, BAMBOO, BARLEY, POPPY SEED, CORN (ZEA MAYS), FLAX SEED (LINUM USITATISSIMUM), BUCKWHEAT (FAGOPYRUM ESULENTUM), MILLET, MILO, OAT, RICE, RYE, LENTILS, SESAME, AMARANTH, SOYBEAN, SUGARCANE (SACCHARUM OFFICINALE), SUNFLOWER SEED, WHEAT, AMARANTH, AVENA SATIVA, NATRUM SULPHURICUM, SARCOLACTICUM ACIDUM, TRITICUM REPENS, ADRENOCORTICOTROPHIN, SYCOTIC CO BACILLUS | Dr. Donna Restivo DC | 719ef104-88f3-4db5-9c3a-1ac9a1a63c26 | 2023-01-10 | Warnings | C151H8M554 |
| Premasol - sulfite-free (Amino Acid) | LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE | Baxter Healthcare Company | 9afdcc3e-0d06-47f4-86ca-40da48b2b02b | 2022-08-04 | Boxed warning, Warnings, Adverse reactions | 4QD397987E |
| 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 | C151H8M554 |
| CLINIMIX E | LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE | Baxter Healthcare Company | 8469d6fb-d6ef-476f-8cc3-0905192de0a8 | 2021-04-13 | Warnings, Adverse reactions | 4QD397987E |
| CLINIMIX | LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DEXTROSE | Baxter Healthcare Corporation | dccff103-8695-400c-a15d-cc2fd078760a | 2021-04-13 | Warnings, Adverse reactions | 4QD397987E |
| Food Additives | IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA, | Newton Laboratories, Inc. | 9a61f1ae-d3a4-68d7-e053-2a95a90a4333 | 2020-12-03 | Warnings | C151H8M554 |
| Food Additives | IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA, | Newton Laboratories, Inc. | 9aefc830-329c-5e35-e053-2a95a90a6ffe | 2020-11-30 | Warnings | C151H8M554 |
| Food Additives | IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA, | Newton Laboratories, Inc. | 9af2d6f4-baa8-5da9-e053-2995a90a3dac | 2020-11-30 | Warnings | C151H8M554 |
| Travasol | LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE | Baxter Healthcare Corporation | 8543b5be-0f43-4891-9e56-d7c39fe839b5 | 2020-10-07 | Warnings, Adverse reactions | 4QD397987E |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.