NDC 42571-509-30 - Sapropterin Dihydrochloride
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
- 42571-509
- Requested NDC
- 42571-509-30
- Package NDCs from labels
- 42571-509-30, 42571-509-41
- Manufacturer
- Micro Labs Limited
- Effective date
- 2026-01-14
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Sapropterin Dihydrochloride - Micro Labs Limited | Micro Labs Limited | 2026-01-14 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42571-509-30 | Sapropterin Dihydrochloride | 1 in 1 PACKET | POWDER, FOR SOLUTION | 1 | 1 | |
| 42571-509-41 | Sapropterin Dihydrochloride | 30 in 1 CARTON | POWDER, FOR SOLUTION | 30 | 1 |
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 |
|---|---|---|---|---|---|---|
| Electrolyte Plus | KALI MURIATICUM, L-ARGININE, L-CARNITINE, L-LEUCINE, L-ORNITHINE, L-VALINE, MAGNESIA MURIATICA, ASCORBICUM ACIDUM, BORAX, CHROMIUM OXYDATUM, FERRUM MURIATICUM, KALI CARBONICUM, MAGNESIUM GLUCONICUM DIHYDRICUM, NATRUM MURIATICUM, ZINCUM GLUCONICUM, CUPRUM METALLICUM, KALI PHOSPHORICUM, NICCOLUM METALLICUM, SELENIUM METALLICUM, VANADIUM METALLICUM, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, MANGANUM CARBONICUM | Deseret Biologicals, Inc. | e3564733-8b88-4753-9077-9d74004d8ec9 | 2026-08-25 | Warnings | PQ6CK8PD0R |
| Mirexa Mini | MIREXA MINI | Oncora Pharma, LLC | ea48f64a-9a70-40df-ba25-098353273089 | 2026-08-25 | Warnings, Adverse reactions | PQ6CK8PD0R |
| Ascorbic Acid | ASCORBIC ACID | Renova Pharmaceuticals LLC | a6481bae-2397-44c7-a51d-4f47ad91bd2c | 2026-08-19 | Warnings, Adverse reactions | PQ6CK8PD0R |
| M-Natal Plus | VITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, THIAMINE, RIBOFLAVIN, NIACIN, VITAMIN B6, FOLIC ACID, VITAMIN B12, CALCIUM, IRON, ZINC, COPPER | REMEDYREPACK INC. | 5d67a268-437b-403d-9d05-6524c4a7c499 | 2026-08-11 | Warnings | PQ6CK8PD0R |
| PNV Prenatol | MULTIVITAMIN | PureTek Corporation | 583f0194-0306-f31b-e063-6394a90a2a10 | 2026-08-06 | Warnings, Adverse reactions | PQ6CK8PD0R |
| sapropterin dihydrochloride | SAPROPTERIN DIHYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | c4d92cce-e899-4f14-b19c-5e17f9922215 | 2026-08-06 | Warnings, Adverse reactions | RG277LF5B3 |
| PRENATE Restore | ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, LACTIC ACID AND DOCONEXENT | Avion Pharmaceuticals, LLC | 1076ba9a-0168-492f-ba9b-99fa02186092 | 2026-07-23 | Boxed warning, Warnings, Adverse reactions | PQ6CK8PD0R |
| PNV-DHA | ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT | Acella Pharmaceuticals, LLC | 038fe2e7-dc16-485c-b5fb-746db7231347 | 2026-07-23 | Boxed warning, Adverse reactions | PQ6CK8PD0R |
| PNV-Omega | ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CORBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM, DOCONEXENT, ICOSAPENT | Acella Pharmaceuticals, LLC | 735c5531-137f-4cee-8c68-ae121045a8ff | 2026-07-22 | Boxed warning, Warnings, Adverse reactions | PQ6CK8PD0R |
| POTASSIUM CITRATE | POTASSIUM CITRATE | Rising Pharma Holdings, Inc. | 164d9d05-fbb1-4d99-8ba3-ff9c172aa8ca | 2026-07-14 | Warnings, Adverse reactions | EE90ONI6FF |
| Minovia Mini | MINOVIA MINI | Oncora Pharma, LLC | 297673c1-23db-47b5-8cfb-aaecc0790838 | 2026-06-24 | Warnings, Adverse reactions | PQ6CK8PD0R |
| MCAS Support | APIS MELLIFICA, ANTIMONIUM CRUDUM, ASCORBICUM ACIDUM, BOVISTA, CARBOLICUM ACIDUM, CHAMOMILLA, CORTISONE ACETICUM, GINKGO BILOBA, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, QUERCETIN, RHUS TOX, SCUTELLARIA LATERIFLORA, STOMACH (SUIS), URTICA URENS | Deseret Biologicals, Inc. | af3d5f8f-6f24-4045-8730-c776ff54bcc4 | 2026-06-24 | Warnings | PQ6CK8PD0R |
| Boostervite | MULTIVITAMIN | PureTek Corporation | 53efbf65-8844-8486-e063-6394a90a51d3 | 2026-06-18 | Warnings, Adverse reactions | PQ6CK8PD0R |
| Vitramyn | FOLIC ACID | PureTek Corporation | c8af7616-5178-6df0-e053-2a95a90a334d | 2026-06-18 | Warnings, Adverse reactions | PQ6CK8PD0R |
| Prenate Mini | ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS ASPARTO GLYCINATE, IRON, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT AND LOWBUSH BLUEBERRY | Avion Pharmaceuticals, LLC | 8ab766c2-d554-4141-92b2-fbe038e80c9f | 2026-06-12 | Boxed warning, Adverse reactions | PQ6CK8PD0R |
| Prenate Essential | ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, BIOTIN, CALCIUM FORMATE, FERROUS ASPARTO GLYCINATE, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT AND ICOSAPENT | Avion Pharmaceuticals, LLC | e5acfb2a-0959-4542-9b4c-790be194d581 | 2026-06-12 | Boxed warning, Warnings, Adverse reactions | PQ6CK8PD0R |
| Prenate Elite | .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CALCIUM FORMATE, FERROUS ASPARTO GLYCINATE, CYANOCOBALAMIN, BIOTIN, POTASSIUM IODIDE, MAGNESIUM OXIDE, ZINC OXIDE AND CUPRIC OXIDE | Avion Pharmaceuticals, LLC | 9b79c950-4312-4a53-9e36-fb8e00b053df | 2026-06-12 | Boxed warning, Adverse reactions | PQ6CK8PD0R |
| GUNA-CELL | ACETYLCARNITINE, L-AMPC-ALPHA-LIPOIC AC-A-TOCOPHEROL-ASCORBIC ACID-CALC CARB-CITRIC AC-COBALAMIN-COLCHICUM-CONIUM-CUPRIC SULF-HERRING SPERM DNA-FERROUS FUMARATE-FOLIC ACID-FUMARIC ACID-KALI ASPARTATE-MANG PHOS-MANG GLUCONATE-MANG PHOS II-PYRUVALDEHYDE-NAT OXALACETICUM-SODIUM PYRUVATE-NIACIN-PANTOTHENIC ACID-PH-PODOPHYLLUM PELTATUM-PYRIDOXINE HYDROCHLORIDE-RIBOFLAVIN-SACCHAROMYCES CEREVISIAE RNA-SELENOMETHIONINE-SUCCINIC ACID-SULFUR-THIAMINE HYDROCHLORIDE-ZINC | Guna spa | 90db80ed-c037-4e8f-a7f6-304a65f9fe22 | 2026-06-11 | Warnings | PQ6CK8PD0R |
| GUNA-MATRIX | ASCORBIC ACID - DODECAHYDROXYCYCLOHEXANE DIHYDRATE - FUCUS VESICULOSUS - HISTIDINE MONOHYDROCHLORIDE - HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED) - HYALURONIDASE - LACTIC ACID, DL - MALIC ACID - NADIDE - PHENYLALANINE - PRASTERONE - PROLACTIN - RANCID BEEF - SODIUM DIETHYL OXALACETATE - SODIUM PYRUVATE - SODIUM SULFATE - SUS SCROFA CONJUNCTIVA - SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE - THUJA OCCIDENTALIS TWIG - TYROSINE - | Guna spa | fa9ed512-97dc-44a2-b32d-86ca8c240532 | 2026-06-11 | Warnings | PQ6CK8PD0R |
| Vitalux | MULTIVITAMIN | PureTek Corporation | 52d5eee7-8146-cc62-e063-6394a90a8c3f | 2026-06-02 | Boxed warning, Adverse reactions | PQ6CK8PD0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.