NDC 55513-103 - IMDELLTRA (AMG757)
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
- 55513-103
- Package NDCs from labels
- 55513-103-01
- Manufacturer
- Amgen, Inc | Immunex Rhode Island Corporation
- Effective date
- 2026-09-11
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| IMDELLTRA (AMG757) - Amgen, Inc | Immunex Rhode Island Corporation | Amgen, Inc | Immunex Rhode Island Corporation | 2026-09-11 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55513-103-01 | IMDELLTRA (AMG757) | 1 mg in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1 mg | 0.9 mg in 1mg | 5 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| PaxLyte | LEUCOVORIN, FOLIC ACID, LEVOMEFOLATE MAGNESIUM, FERROUS CYSTEINE GLYCINATE, 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, PHOSPHATIDYL SERINE, PYRIDOXAL 5-PHOSPHATE, FLAVIN ADENINE DINUCLEOTIDE, NADH, COBAMAMIDE, COCARBOXYLASE (THIAMINE PYROPHOSPHATE), MAGNESIUM ASCORBATE, ZINC ASCORBATE, MAGNESIUM L-THREONATE AND BETAINE CAPSULE | Jaymac Pharmaceuticals | f520b130-61b3-443e-aaf6-91e094e7a334 | 2025-12-08 | Warnings, Adverse reactions | 2968PHW8QP |
| Alka-Seltzer Heartburn | ANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED) | Bayer HealthCare LLC. | 55158e50-0327-2043-e054-00144ff8d46c | 2025-12-04 | Warnings | 2968PHW8QP |
| Alka-Seltzer Gold | ALKA-SELTZER GOLD | Bayer HealthCare LLC. | 0824bedb-413b-2fa0-e054-00144ff88e88 | 2025-12-04 | Warnings | 2968PHW8QP |
| Earthmed Soothe Chewable Orange | CITRIC ACID | Earthmed LLC | 439543fe-ceb9-4c5c-e063-6294a90a9b70 | 2025-11-14 | Warnings | 2968PHW8QP |
| AQUACETIC-30 | CLEANING SOLUTION FOR HEMODIALYSIS MACHINES | Aqua Medica, S.A. de C.V. | 040775ab-41bd-cd36-e063-6394a90a08aa | 2025-11-10 | Warnings | 2968PHW8QP |
| CITRACID-50 | DESINFECTANT SOLUTION FOR HEMODIALYSIS MACHINE | Aqua Medica, S.A. de C.V. | 040713e7-67cd-8eb0-e063-6394a90aa2a9 | 2025-11-10 | Warnings | 2968PHW8QP |
| 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 | 3KX376GY7L |
| 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 | 3KX376GY7L |
| 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 | 3KX376GY7L |
| 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 | 3KX376GY7L JNJ23Q2COM |
| 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 | 3KX376GY7L JNJ23Q2COM |
| Medique Medi Seltzer | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Unifirst First Aid Corporation | 528da9d9-2a52-4c16-b7b2-61b3eee1abea | 2025-08-19 | Warnings | 2968PHW8QP |
| 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 |
| 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 |
| Phexx | LACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM BITARTRATE | Evofem, Inc. | 14b01a15-9b47-4be3-bb2e-a2010eab429e | 2025-05-02 | Warnings, Adverse reactions | 2968PHW8QP |
| Tricitrates | TRICITRATES | Chartwell RX, LLC | 2a80ea6b-6334-4c33-a35e-a5cb2939fbcb | 2025-04-28 | Warnings, Adverse reactions | 2968PHW8QP |
| Potassium Citrate and Citric Acid | POTASSIUM CITRATE AND CITRIC ACID | Chartwell RX, LLC | 978a5a9d-f0ca-4308-a84b-3b132263bbb8 | 2025-04-09 | Warnings, Adverse reactions | 2968PHW8QP |
| Alka-Seltzer Heartburn Relief Lemon Lime | ANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED) | Bayer Healthcare LLC | cc21af24-9a5b-6831-e053-2a95a90a0af4 | 2025-04-01 | Warnings | 2968PHW8QP |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.