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 9 of 14 · 269 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
sapropterin dihydrochlorideSAPROPTERIN DIHYDROCHLORIDENorthStar RxLLCa64a50ba-e3da-4227-9bce-87101d60409e2025-01-06Warnings, Adverse reactionsExact identifier
unii: RG277LF5B3
POTASSIUM CITRATEPOTASSIUM CITRATEBryant Ranch Prepack012c925e-5874-472b-a675-00bf79f649802024-12-24Warnings, Adverse reactionsExact identifier
unii: EE90ONI6FF
TeethWhitening KitTEETHWHITENING KITJiangxi Dentalbright Technology Co., Ltd.29393313-217a-dc3a-e063-6294a90addb12024-12-20WarningsExact identifier
unii: EE90ONI6FF
Teeth Whitening KitTEETH WHITENING KITJiangxi Dentalbright Technology Co., Ltd0973b73d-5de9-0986-e063-6294a90a59172024-12-20WarningsExact identifier
unii: EE90ONI6FF
Mast Cell ProHYDRASTIS CANADENSIS, ASCORBICUM ACIDUM, CINCHONA OFFICINALIS, KIDNEY (SUIS), THIAMINUM HYDROCHLORICUM, URTICA DIOICA, APIS MELLIFICA, ARSENICUM ALBUM, BOVISTA, CARBOLICUM ACIDUM, COFFEA CRUDA, HISTAMINUM HYDROCHLORICUM, LACHESIS MUTUS, LEDUM PALUSTRE, NUX VOMICA, OXALICUM ACIDUM, PHOSPHORUS, RHUS TOX, SARCOLACTICUM ACIDUM, SECALE CORNUTUM, SEPIA, SEROTONIN (HYDROCHLORIDE), SULPHUR, THUJA OCCIDENTALIS, VENUS MERCENARIA, ACONITUM NAPELLUS, CALADIUM SEGUINUM, IGNATIA AMARA, NATRUM MURIATICUM,Energique, Inc.5cd31e1d-0312-48d1-9ecd-d01c6fe3b6722024-12-11WarningsExact identifier
unii: PQ6CK8PD0R
VentrixylFOLIC ACIDPureTek Corporationc29dc729-93be-2a20-e053-2a95a90a8ca32024-12-03Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Folitin-ZFERROUS FUMARATE, FOLIC ACIDPureTek Corporationbb141ac2-e5df-4df4-e053-2995a90a6e722024-12-02Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Davimet with IronIRON, FOLATEPureTek Corporation1445921b-5bf4-ea48-e063-6294a90abb1a2024-11-27Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
FoliflexFERROUS FUMARATE, FOLIC ACIDPureTek Corporationcba98d1a-8cf9-39d9-e053-2995a90ae8bb2024-11-27Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Potassium Citrate and Citric AcidPOTASSIUM CITRATE AND CITRIC ACID MONOHYDRATEPAI Holdings, LLC dba PAI Pharmace42122f-8087-471f-b0a3-5524bdbd45262024-11-19Warnings, Adverse reactionsExact identifier
unii: EE90ONI6FF
TRICITRATESPOTASSIUM CITRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATEPAI Holdings, LLC dba PAI Pharma2ecb42a2-82f1-456b-8f1e-02c2d0a7b5ad2024-11-15Warnings, Adverse reactionsExact identifier
unii: EE90ONI6FF
FinazolFERROUS FUMARATE, FOLATEPureTek Corporation24290823-022a-433b-e063-6394a90a8fd02024-11-07Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
RecovatoneGLYCYRRHIZA GLABRA, KALI MURIATICUM, KALI PHOSPHORICUM, IODIUM, ZINCUM GLUCONICUM, PHOSPHORUS, ASCORBICUM ACIDUM, CALCIUM GLUCONATE, L-ARGININE, L-CARNITINE, L-ORNITHINE, MAGNESIA MURIATICA, MAGNESIUM GLUCONICUM DIHYDRICUM, MANGANESE GLUCONATE, NATRUM MURIATICUM, COBALT GLUCONATE, COPPER GLUCONATE, CREATINE, L-GLUTAMINE, L-LEUCINE, L-VALINE, POTASSIUM GLUCONATE, SELENIUM DIOXIDE, ADRENALINUM, BORON, CALCAREA PHOSPHORICA, FERRUM SULPHURICUM, MOLYBDENUM, NICCOLUM METALLICUM, SELENIUM METALLICUM,Energique, Inc.38fd4f98-a42a-435b-9643-16df664539512024-10-29WarningsExact identifier
unii: PQ6CK8PD0R
JAVYGTORSAPROPTERIN DIHYDROCHLORIDEDr. Reddys Laboratories Inceecdd8c7-5f8a-0af1-793a-db2e2ba0f4912024-10-22Warnings, Adverse reactionsExact identifier
rxcui: 1653217
unii: RG277LF5B3
MetoxALLIUM 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, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, LANTHANUM METALLICUM, NIOBIUM METALLICUM, NIOBIUM,Deseret Biologicals, Inc.ddaedfad-c7d1-4aeb-a52e-dce5c1b45c922024-10-22WarningsExact identifier
unii: PQ6CK8PD0R
JAVYGTORSAPROPTERIN DIHYDROCHLORIDEDr. Reddys Laboratories Incd9f3723f-bf7d-9a72-2ef9-41c5508d6ab42024-10-21Warnings, Adverse reactionsExact identifier
unii: RG277LF5B3
JAVYGTORSAPROPTERIN DIHYDROCHLORIDEDr. Reddys Laboratories Inc1590afa1-baa4-70e5-5a3b-468401c710442024-10-21Warnings, Adverse reactionsExact identifier
rxcui: 1111018
unii: RG277LF5B3
MetabolismBERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS PURSHIANA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, ASCORBICUM ACIDUM, METHYLCOBALAMIN, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, GERMANIUM SESQUIOXIDE, CYSTEINUM, MANGANESE GLUCONATE, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, FUMARICUM ACIDUM, MAGNESIA PHOSPHORICA, NATRUM OXALACETICUM, PULSATILLA (VULGARIS), PYRUVIC ACID, UBIDECARENONUM, HEPAR SULPHURIS CALCAREUMBioActive Nutritional, Inc.76f70259-44b1-467a-bff4-b427ddfe3abd2024-10-17WarningsExact identifier
unii: PQ6CK8PD0R
PrenatrylFERROUS FUMARATE, FOLIC ACIDPureTek Corporationb364551b-2ccc-4db3-e053-2995a90afbbf2024-10-08Boxed warning, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Bio Co-Enzyme PhaseCARDUUS MARIANUS, ASCORBICUM ACIDUM, CYSTEINUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PULSATILLA (PRATENSIS), PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CERIUM OXALICUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MAGNESIUM OROTICUM DIHYDRICUM, MALICUM ACIDUM, NADIDUM, NATRUM PYRUVICUM, PANTOTHENIC ACID, SUCCINICUM ACIDUM, ADRENALINUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, HEPAR SULPHURIS CALCAREUM, SULPHUR, ACONITICUM ACIDUM, CIS-,Deseret Biologicals, Inc.afad858e-064f-454d-be78-da1501ffe8532024-10-04WarningsExact identifier
unii: PQ6CK8PD0R

Reported adverse events (FAERS/openFDA)#

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