FDA.reportPublic FDA data

NDC 31722-047-01 - 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
31722-047
Requested NDC
31722-047-01
Package NDCs from labels
31722-047-01, 31722-047-30, 31722-047-31
Manufacturer
Camber Pharmaceuticals, Inc. | Annora Pharma Private Limited
Effective date
2026-03-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ASCORBIC ACID - Camber Pharmaceuticals, Inc. | Annora Pharma Private LimitedCamber Pharmaceuticals, Inc. | Annora Pharma Private Limited2026-03-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-047-01Sapropterin dihydrochloride1 in 1 PACKETPOWDER, FOR SOLUTION13
31722-047-30Sapropterin dihydrochloride30 in 1 CARTONPOWDER, FOR SOLUTION303
31722-047-31Sapropterin dihydrochloride1 in 1 CARTONPOWDER, FOR SOLUTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-047SAPROPTERIN DIHYDROCHLORIDE (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [CAMBER PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 3 package rows20240710_3f0d6820-ff59-40c0-882f-aeea2dd1d1ad.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-047-01EA - Each31722-0476d999e39-c76a-4e90-a95f-2b63fee7baf512023-02-06
31722-047-30EA - Each31722-047678de7e0-b1a3-4e6c-834f-d0a8baadefce12023-02-06

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.

Matched openFDA labels page 7 of 14 · 269 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
POTASSIUM CITRATE EXTENDED RELEASEPOTASSIUM CITRATEStrides Pharma Inc.5f38b02c-703c-4fc2-b833-654e41bd617f2025-07-01Warnings, Adverse reactionsExact identifier
unii: EE90ONI6FF
MELAO WHITENING SUNSCREENTITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd1aaf5942-ff13-ee07-e063-6394a90acd282025-06-25WarningsExact identifier
unii: PQ6CK8PD0R
Silicone Scar CreamDIMETHICONE, ASCORBIC ACID, TOCOPHEROL, PANTHENOL, ALLANTOINYunqi Cosmetics (Shenzhen) Co., Ltd37d02d8c-fbb5-5ba5-e063-6294a90a43ac2025-06-17WarningsExact identifier
unii: PQ6CK8PD0R
MaterviaASCORBIC ACID, CHOLECALCIFEROL, THIAMINE, PYRIDOXAL-5-PHOSPHATE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CITRATE, IRON, IODINEV2 Pharma LLCa918e273-4742-4417-8ae5-88d3870011f02025-06-11WarningsExact identifier
unii: PQ6CK8PD0R
Sapropterin DihydrochlorideSAPROPTERIN DIHYDROCHLORIDEAurobindo Pharma Limited11ee25bc-f501-4f9d-b63d-63b2eee0147e2025-06-10Warnings, Adverse reactionsExact identifier
unii: RG277LF5B3
MetDetoxALLIUM SATIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, ASCORBICUM ACIDUM, CYSTEINUM, L-METHIONINE, PHYTOLACCA DECANDRA, THYROIDINUM (SUIS), CARBOLICUM ACIDUM, FORMALINUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, BORON, ARSENICUM ALBUM, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, LANTHANUM METALLICUM, NIOBIUM METALLICUM, TANTALUM METALLICUM, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM,Dr. Donna Restivo DC89ce5e89-c592-445e-92f9-365133005fb32025-05-23WarningsExact identifier
unii: PQ6CK8PD0R
Sinus TonicECHINACEA (ANGUSTIFOLIA), BAPTISIA TINCTORIA, THIAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, PYRIDOXINUM HYDROCHLORICUM, SPONGIA TOSTA, APIS MELLIFICA, ASCORBIC ACID, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LACHESIS MUTUS, MERCURIUS IODATUS RUBER, MERCURIUS SULPHURATUS RUBER, PULSATILLA (PRATENSIS), SILICEA, SINUSITISINUM, PANTOTHENIC ACIDBioActive Nutritional, Inc.63234fdc-7456-42c6-8996-fef372dd4a532025-05-20WarningsExact identifier
unii: PQ6CK8PD0R
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
CobalefolVITAMINV2 Pharma LLC7d409065-112d-4bc7-bae6-d558aeb7c0e42025-05-16WarningsExact identifier
unii: PQ6CK8PD0R
YVTYVT DARK SPOTDARK SPOTBeijing JUNGE Technology Co., Ltd.352699fa-f746-c931-e063-6394a90a63912025-05-15WarningsExact identifier
unii: PQ6CK8PD0R
MultivitaminMULTIVITAMINPureTek Corporation353453e2-1f60-24ea-e063-6394a90a251e2025-05-15Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Prenate PixieASCORBIC ACID, BIOTIN, CHOLECALCIFEROL, CYANOCOBALAMIN, LEVOMEFOLATE CALCIUM, FOLIC ACID, FERROUS ASPARTO GLYCINATE, POTASSIUM IODIDE, PYRIDOXINE HYDROCHLORIDE, .ALPHA.-TOCOPHEROL ACETATE, DL-, DOCOSAHEXAENOIC ACID, AND BLUEBERRYAvion Pharmaceuticals, LLCfe0a737e-4f28-40d8-b4a7-090edf86a8232025-05-14Boxed warning, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Prenatal Vitamins Plus Low IronPRENATAL WITH FERROUS FUMARATE AND FOLIC ACIDA-S Medication Solutionsed793721-e869-43de-9d6e-6dc9c8230e362025-05-07Boxed warningExact identifier
unii: PQ6CK8PD0R
POTASSIUM CITRATE EXTENDED RELEASEPOTASSIUM CITRATEBryant Ranch Prepack8f5f7078-3c2d-406f-9222-b82a0f79d1682025-05-02Warnings, Adverse reactionsExact identifier
unii: EE90ONI6FF
POTASSIUM CITRATE EXTENDED RELEASEPOTASSIUM CITRATEBryant Ranch Prepackb6ce81aa-ed9e-4eac-9f9c-26e2560f06db2025-05-02Warnings, Adverse reactionsExact identifier
unii: EE90ONI6FF
ZELVYSIASAPROPTERIN DIHYDROCHLORIDEAucta Pharmaceuticals, Inc.8de84882-dd24-46f2-8416-5e492d4275d12025-04-30Warnings, Adverse reactionsExact identifier
rxcui: 1653217
rxcui: 1111018
unii: RG277LF5B3
YVTYVT Dark Spot Remover SerumASCORBIC ACID, KOJIC ACIDBeijing JUNGE Technology Co., Ltd.33d1e559-c86b-3d4d-e063-6294a90af2fa2025-04-28WarningsExact identifier
unii: PQ6CK8PD0R
TricitratesTRICITRATESChartwell RX, LLC2a80ea6b-6334-4c33-a35e-a5cb2939fbcb2025-04-28Warnings, Adverse reactionsExact identifier
unii: EE90ONI6FF
SILICONE SCAR CreamDIMETHICONE, ASCORBIC ACID, TOCOPHEROL, PANTHENOL, ALLANTOINYunqi Cosmetics (Shenzhen) Co., Ltd338180f7-2449-3d13-e063-6294a90a90832025-04-24WarningsExact identifier
unii: PQ6CK8PD0R
Potassium Citrate and Citric AcidPOTASSIUM CITRATE AND CITRIC ACIDChartwell RX, LLC978a5a9d-f0ca-4308-a84b-3b132263bbb82025-04-09Warnings, Adverse reactionsExact identifier
unii: EE90ONI6FF

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.