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 10 of 14 · 269 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PrenatrixFERROUS FUMARATE, FOLIC ACIDPureTek Corporationae07585b-e6e4-fd6d-e053-2995a90a7eec2024-09-30Boxed warning, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
PretrateFERROUS FUMARATE, FOLIC ACIDPureTek Corporationba4a1424-0782-77c0-e053-2a95a90a6e442024-09-30Boxed warning, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
DavimetMULTIVITAMINPureTek Corporatione4a57710-caa9-51e5-e053-2a95a90a8ad02024-09-13Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Potassium CitratePOTASSIUM CITRATEAmerican Health Packaging1201c777-2388-4235-bb8f-eb7dc1e867f82024-09-03Warnings, Adverse reactionsExact identifier
unii: EE90ONI6FF
KuvanSAPROPTERIN DIHYDROCHLORIDEBioMarin Pharmaceutical Inc.af38711e-8873-4790-a92d-4d583e23fb892024-08-26Warnings, Adverse reactionsExact identifier
rxcui: 1653217
rxcui: 1111018
unii: RG277LF5B3
Multi-PhenolicMANNOSE, 5-HYDROXYTRYPTOPHAN, ACETALDEHYDE, ACETYLCHOLINE CHLORIDE, ASCORBICUM ACIDUM, ASPARTAME, BUTYLATED HYDROXYTOLUENE, CAFFEIC ACID, CANDIDA ALBICANS, CINNAMIC ACID, CONIFERYL ALCOHOL, COUMARINUM, DOPAMINE HYDROCHLORIDE, ESTRADIOL, GABA (GAMMA-AMINOBUTYRIC ACID), GALLICUM ACIDUM, HISTAMINUM HYDROCHLORICUM, HYDROCORTISONE, INDOLUM, L-DOPA, L-PHENYLALANINE, MELATONIN, MENADIONE, NOREPINEPHRINE (BITARTRATE), PETROSELINUM CRISPUM, PHENYL ISOTHIOCYANATE, PIPERINE, PROGESTERONE, PYRROLE, QUERCETIN,Energique, Inc.492b412a-01cc-48f2-bcdc-6fffcc6519632024-08-23WarningsExact identifier
unii: PQ6CK8PD0R
Potassium CitratePOTASSIUM CITRATEBryant Ranch Prepackf2ab3c2e-2a6e-4698-afad-260bdf0d259e2024-08-06Warnings, Adverse reactionsExact identifier
unii: EE90ONI6FF
Sapropterin dihydrochlorideSAPROPTERIN DIHYDROCHLORIDENorthStar RxLLCb3999f74-920d-4444-afa7-f4211e4eb4312024-07-09Warnings, Adverse reactionsExact identifier
application number: ANDA215420
rxcui: 1653217
rxcui: 1111018
unii: RG277LF5B3
AllergiesAPIS 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, CINNAMOMUMNewton Laboratories, Inc.9d5dea47-5103-21a3-e053-2995a90aee782024-05-20WarningsExact identifier
unii: PQ6CK8PD0R
POTASSIUM CITRATE EXTENDED RELEASEPOTASSIUM CITRATEBryant Ranch Prepack9774b7c5-4695-47c9-9eb8-e0af2e05f5c32024-05-20Warnings, Adverse reactionsExact identifier
unii: EE90ONI6FF
Bio Tonsilla PhaseDULCAMARA, ECHINACEA (ANGUSTIFOLIA), AESCULUS HIPPOCASTANUM, ANTIMONIUM TARTARICUM, ASCORBICUM ACIDUM, COCCUS CACTI, GALIUM APARINE, GENTIANA LUTEA, GERANIUM ROBERTIANUM, PULSATILLA (PRATENSIS), SARCOLACTICUM ACIDUM, ACETYLCHOLINE CHLORIDE, MANNOSE, CONIUM MACULATUM, LYMPH NODE (SUIS), SULPHUR, CALCAREA PHOSPHORICA, FUNICULUS UMBILICALIS SUIS, HEPAR SUIS, HYPOTHALAMUS SUIS, MEDULLA OSSIS SUIS, SPLEEN (SUIS), CORTISONE ACETICUM, GLANDULA SUPRARENALIS SUIS, MERCURIUS SOLUBILIS, THYROIDINUM (SUIS),Deseret Biologicals, Inc.74f899ed-8021-470a-995b-4822da412c502024-05-07WarningsExact identifier
unii: PQ6CK8PD0R
Prenatol-MMULTIVITAMINPureTek Corporation17559a44-94b7-9ca0-e063-6294a90a21232024-05-06Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Vitamin C 15 %L-ASCORBIC ACIDPURETEK CORPORATION11741b56-0fc4-f0d6-e063-6394a90ae6aa2024-05-06WarningsExact identifier
unii: PQ6CK8PD0R
Vitamin C 10 %L-ASCORBIC ACIDPURETEK CORPORATION1019e858-3d5f-64b5-e063-6394a90a6cf02024-05-06WarningsExact identifier
unii: PQ6CK8PD0R
Occuloplex GEUPHRASIA OFFICINALIS, GINKGO BILOBA, PETROSELINUM SATIVUM, VACCINIUM MYRTILLUS, ASCORBICUM ACIDUM, SPIGELIA ANTHELMIA, EYE (SUIS), GERMANIUM SESQUIOXIDE, UBIDECARENONUM, AURUM METALLICUM, BRYONIA (ALBA), HEPAR SULPHURIS CALCAREUM, PHOSPHORUS, RUTA GRAVEOLENS, SULPHUR, LITHIUM METALLICUMBioActive Nutritional, Inc.c982e701-129c-4b55-b8e6-ff05178384922024-05-02WarningsExact identifier
unii: PQ6CK8PD0R
GlucoregASCORBICUM ACIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SARCOLACTICUM ACIDUM, THIAMINUM HYDROCHLORICUM, DHEA (DEHYDROEPIANDROSTERONE), ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-LIPOICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, NADIDUM, PANTOTHENIC ACID, ACETALDEHYDE, INSULINUM (SUIS), INSULINUM (HUMAN), HEPAR SUIS, PANCREAS SUIS, PHLORIDZINUM, ALLOXANUM, BERBERIS VULGARIS, CARCINOSIN, LYCOPODIUM CLAVATUM, MOMORDICA BALSAMINA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SYZYGIUM JAMBOLANUM,Deseret Biologicals, Inc.c77d0682-a000-4783-a91c-d4e205c347742024-04-29WarningsExact identifier
unii: PQ6CK8PD0R
Multitol-MMULTIVITAMIN, FOLATEPureTek Corporation163fdc9e-a405-c3ee-e063-6294a90afd492024-04-17Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Male StimulantARALIA QUINQUEFOLIA, AGNUS CASTUS, ASCORBICUM ACIDUM, CALADIUM SEGUINUM, KALI BROMATUM, CANTHARIS, DAMIANA, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, ORCHITINUM (SUIS), PROSTATE (SUIS), STRYCHNINUM PHOSPHORICUM, CONIUM MACULATUM, DIENCEPHALON (SUIS), HEART (SUIS), FERRUM PHOSPHORICUM, MAGNESIA PHOSPHORICA, SELENIUM METALLICUM, ZINCUM METALLICUM, PINEAL GLAND (SUIS), CORTISONE ACETICUM, MANGANUM PHOSPHORICUM, LYCOPODIUM CLAVATUM, TESTOSTERONE, MORGAN GAERTNERDeseret Biologicals, Inc.d48437d6-a54f-4e11-bcfb-9e0d5c1e98da2024-04-15WarningsExact identifier
unii: PQ6CK8PD0R
Integra PlusFERROUS FUMARATE AND POLYSACCHRIDE IRON VITAMIN MINERAL COMPLEX SUPPLEMENTU.S. Pharmaceutical Corporation9e5b9309-e835-4863-ab6f-e3018e38fc642024-04-03Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Bio Lymph PhaseTEUCRIUM SCORODONIA, VERONICA OFFICINALIS, EQUISETUM HYEMALE, FUMARIA OFFICINALIS, GERANIUM ROBERTIANUM, NASTURTIUM AQUATICUM, NATRUM SULPHURICUM, PINUS SYLVESTRIS, GENTIANA LUTEA, JUGLANS REGIA, ARANEA DIADEMA, SARSAPARILLA (SMILAX REGELII), ASCORBICUM ACIDUM, QUERCETIN, SCROPHULARIA NODOSA, MYOSOTIS ARVENSIS, CALCAREA PHOSPHORICA, FERRUM IODATUM, THYROIDINUM (SUIS), GAERTNER BACILLUS (BACH)Deseret Biologicals, Inc.b7ba12b8-32e2-4e83-a947-d0a1e91e65d12024-03-15WarningsExact identifier
unii: PQ6CK8PD0R

Reported adverse events (FAERS/openFDA)#

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