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 4 of 14 · 269 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mitochondria ProARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.2f365207-b730-428d-9465-8853e86e79ff2026-02-18WarningsExact identifier
unii: PQ6CK8PD0R
AfloraMULTIVITAMINOncora Pharma, LLC38e463d1-f608-7cb5-e063-6294a90a4abb2026-02-12Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
FolixiaMULTIVITAMINOncora Pharma, LLC413945b5-116b-d8b6-e063-6394a90a55e82026-02-12Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
NutralynMULTIVITAMINOncora Pharma, LLC33da017b-1e8c-d41c-e063-6394a90aab8c2026-02-12Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
FolatenMULTIVITAMINOncora Pharma, LLC93086235-2c33-424d-b0c3-2130319885812026-02-12Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Floravita MiniFLORAVITA MINIFlorrax Pharmaceutical682bda57-21e0-47df-9596-78846d4d97c02026-02-12Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Vitamin C SerumVITAMIN CFlexiGo Inc496e7d41-2176-7b0c-e063-6394a90a98f12026-01-28WarningsExact identifier
unii: PQ6CK8PD0R
Dialyvite 5000ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUMHillestad Pharmaceuticals USA97791f73-e0c5-45a6-8aed-f456a5466eaf2026-01-27Adverse reactionsExact identifier
unii: PQ6CK8PD0R
DialyviteASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACIDHillestad Pharmaceuticals USA7a5e6dd6-5687-44bb-8964-841961c0e64a2026-01-27Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Dialyvite Supreme DASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUMHillestad Pharmaceuticals USA46fc3acf-1e6d-4830-ae9a-abd9c1132fca2026-01-27Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Sapropterin DihydrochlorideSAPROPTERIN DIHYDROCHLORIDEMicro Labs Limited907e24c4-3337-4aee-b789-276e37a85cd82026-01-14Warnings, Adverse reactionsExact identifier
rxcui: 1653217
rxcui: 1111018
unii: RG277LF5B3
Pyrogenium Combination 9239PYROGENIUM COMBINATIONProfessional Complementary Health Formulas8b869987-bfd2-4451-a2a8-ce3a92e201f22026-01-08WarningsExact identifier
unii: PQ6CK8PD0R
Artificial Sweetener Detox 6034ARTIFICIAL SWEETENER DETOXProfessional Complementary Health Formulas38f2ae0b-2b1f-4b49-934d-fe1556f84d932026-01-08WarningsExact identifier
unii: 96K6UQ3ZD4
C-Balance Liquescence 3022C-BALANCE LIQUESCENCEProfessional Complementary Health Formulase209f9bc-9d85-4ab7-8d41-187b65c548722026-01-08WarningsExact identifier
unii: PQ6CK8PD0R
CitraNatal 90 DHAVITAMIN C, CALCIUM, IRON, VITAMIN D3, VITAMIN E, THIAMIN, RIBOFLAVIN, NIACINAMIDE, VITAMIN B6, FOLIC ACID, IODINE, ZINC, COPPER, DOCUSATE SODIUMMission Pharmacal Company81e639d7-352e-4eaa-87d9-582da68b97282026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Cellular Oxygenator Drops 2095CELLULAR OXYGENATOR DROPSProfessional Complementary Health Formulas5aba4627-6078-4c9e-93ee-690cfe3439cf2026-01-08WarningsExact identifier
unii: PQ6CK8PD0R
Mucolytic Drainage Liquescence 3017MUCOLYTIC DRAINAGE LIQUESCENCEProfessional Complementary Health Formulasf6dd9b87-053d-4d88-b0e4-7693f5524ce72026-01-08WarningsExact identifier
unii: PQ6CK8PD0R
Anti-Hives Drops 2004ANTI-HIVES DROPSProfessional Complementary Health Formulas45ae94f2-4310-41d3-8532-ef9b132b32822026-01-08WarningsExact identifier
unii: PQ6CK8PD0R
Pain Formula Drops 2046PAIN FORMULA DROPSProfessional Complementary Health Formulas4456c022-5aac-49b4-b976-b629525f3d492026-01-08WarningsExact identifier
unii: PQ6CK8PD0R
Ferralet 90IRON, FOLIC ACID, CYANOCOBALAMIN, ASCORBIC ACID, AND DOCUSATE SODIUMMission Pharmacal Company0be2918e-55b3-4c66-aba0-09099a1c77702026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R

Reported adverse events (FAERS/openFDA)#

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