FDA.reportPublic FDA data

NDC 72603-194-01 - 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
72603-194
Requested NDC
72603-194-01
Package NDCs from labels
72603-194-01, 72603-194-30
Manufacturer
NorthStar RxLLC | Annora Pharma Private Limited
Effective date
2024-07-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sapropterin dihydrochloride - NorthStar RxLLC | Annora Pharma Private LimitedNorthStar RxLLC | Annora Pharma Private Limited2024-07-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72603-194-01Sapropterin dihydrochloride1 in 1 PACKETPOWDER, FOR SOLUTION13
72603-194-30Sapropterin dihydrochloride30 in 1 CARTONPOWDER, FOR SOLUTION303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-194SAPROPTERIN DIHYDROCHLORIDE (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [NORTHSTAR RXLLC]3Current NDC, 2 package rows20240710_b3999f74-920d-4444-afa7-f4211e4eb431.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-194-01EA - Each72603-19448724ae9-c801-4bc0-9e1e-11de0fb3b19b12024-07-12
72603-194-30EA - Each72603-1949158e7b3-b6d9-48d7-976e-cba67d2c055b12023-12-05

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 8 of 14 · 263 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vitafol Fe PlusDOCONEXENT, NIACINAMIDE, .ALPHA.-TOCOPHEROL ACETATE, DL-, CHOLECALCIFEROL, BETA CAROTENE, ASCORBIC ACID, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, IRON, ZINC OXIDE, CUPRIC OXIDE, POTASSIUM IODIDE, MAGNESIUM OXIDE, FOLIC ACID, AND LEVOMEFOLATE CALCIUMExeltis USA, Inc.3927b074-d72a-4d8c-9f7e-15c42a8309452025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Vitafol OnePRENATAL SUPPLEMENT WITH DHAExeltis USA, Inc.42a5cafd-a2c0-4ac2-99c9-708642f007162025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Vitafol UltraDOCONEXENT, NIACINAMIDE, .ALPHA.-TOCOPHEROL ACETATE, DL-, CHOLECALCIFEROL, .BETA.-CAROTENE, ASCORBIC ACID, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, IRON, ZINC OXIDE, CUPRIC OXIDE, POTASSIUM IODIDE, MAGNESIUM OXIDE, FOLIC ACID, AND LEVOMEFOLATE CALCIUMExeltis USA, Inc.40fa2c3a-f41f-434c-91de-5150a18d3e4b2025-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Aspartame/MSG DetoxCHELIDONIUM MAJUS, ARNICA MONTANA, PHYTOLACCA DECANDRA, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BISPHENOL A (BPA), DEXTROSE, MALTODEXTRIN, SUCRALOSE, ASPARTIC ACID, DIKETOPIPERAZINE, DOPAMINE HYDROCHLORIDE, FORMALINUM, FORMICUM ACIDUM, L-PHENYLALANINE, METHYL ALCOHOL, MONOSODIUM GLUTAMATEDeseret Biologicals, Inc.a1dc1bf3-db71-4550-a975-4f146fb940052025-03-11WarningsExact identifier
unii: 96K6UQ3ZD4
Se-Natal 19.BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM PANTOTHENATE, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE AND DOCUSATE SODIUMSeton Pharmaceuticals635104e6-6a53-4684-ac9a-7ac31b33083d2025-02-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
NOAVIA Retinol MoisturizerCAFFEINE,ASCORBIC ACID,TOCOPHEROL,RETINOL,HYDROLYZED COLLAGEN,VITAMIN ABeijing JUNGE Technology Co., Ltd.2e9da737-d0fe-79ff-e063-6394a90a83582025-02-20WarningsExact identifier
unii: PQ6CK8PD0R
QIDILA Whitening Skin Lightening CreamBUTYLENE GLYCOL,BUTYROSPERMUM PARKII (SHEA BUTTER),KYOUNIN YU,TOCOPHEROL,ASCORBIC ACID,NIACINAMIDEBeijing JUNGE Technology Co., Ltd.2e66a508-3f56-4500-e063-6394a90aaa9d2025-02-18WarningsExact identifier
unii: PQ6CK8PD0R
FEELSHION Dark Spot Remover SerumASCORBIC ACID,GLUTATHIONE,NIACINAMIDE,KOJIC ACIDBeijing JUNGE Technology Co., Ltd.2e770e4d-e98c-6ee2-e063-6394a90a433f2025-02-18WarningsExact identifier
unii: PQ6CK8PD0R
Progena ImmugenARALIA QUINQUEFOLIA, ECHINACEA, PHYTOLACCA DECANDRA, ASCORBIC ACID, BETA CAROTENE, GLANDULA SUPRARENALIS, PYRIDOXINUM HYDROCHLORICUM, SPLEEN, THYMUS, SELENIUM METALLICUM, VITAMIN E, ZINCUM METALLICUMMeditrend, Inc. DBA Progena Professional Formulations6df039e8-b6e8-489f-87de-af71efd1f7b72025-01-29WarningsExact 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.8ca76872-a187-4fd8-8daf-9ee351bdf3462025-01-28WarningsExact identifier
unii: PQ6CK8PD0R
MetoxALLIUM SATIVUM, ARSENICUM ALBUM, ASCORBICUM ACIDUM, BERBERIS VULGARIS, BORON, CARBOLICUM ACIDUM, CYSTEINUM, FORMALINUM, GLYCYRRHIZA GLABRA, LANTHANUM METALLICUM, LAPPA MAJOR, L-METHIONINE, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NIOBIUM METALLICUM, NUX VOMICA, PHYTOLACCA DECANDRA, PLUMBUM METALLICUM, STILLINGIA SYLVATICA, TANTALUM METALLICUM, THYROIDINUM (SUIS), TRIFOLIUM PRATENSE, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM,Deseret Biologicals, Inc.deeae030-c266-44ab-8bc7-32c3292c72472025-01-17WarningsExact identifier
unii: PQ6CK8PD0R
D-105BOS TAURUS ADRENAL GLAND, APIS MELLIFERA, ARSENIC TRIOXIDE, LYTTA VESICATORIA, BOS TAURUS LYMPH VESSEL, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, URTICA URENS, PYRIDOXINE HYDROCHLORIDE, AND ASCORBIC ACIDDNA Labs, Inc.1535cb47-b155-4ac4-af7d-b22ac83254032025-01-13WarningsExact identifier
unii: PQ6CK8PD0R
N-17ZINC, SELENIUM, BOS TAURUS THYMUS, SUS SCROFA SPLEEN, BOS TAURUS LYMPH, BOS TAURUS ADRENAL GLAND, ARGININE, CYSTINE, ECHINACEA ANGUSTIFOLIA, THIAMINE, PYRIDOXINE HYDROCHLORIDE, AND ASCORBIC ACIDDNA Labs, Inc.a6a13048-b1b4-4a46-acad-d379d4e4b6fb2025-01-09WarningsExact identifier
unii: PQ6CK8PD0R
N-16MGO ENERGIZERDNA Labs, Inc.8292b900-86c1-47ea-81da-b587439c76642025-01-09WarningsExact identifier
unii: PQ6CK8PD0R
AOA0 Snail Ginseng CreamSNAIL SECRETION FILTRATE,PANAX GINSENG ROOT EXTRACT,COLLAGEN,TOCOPHEROL,ASCORBIC ACID.Guangdong Junhui Biotechnology Co., LTD22873a99-1032-f4ec-e063-6394a90a64322025-01-08WarningsExact identifier
unii: PQ6CK8PD0R
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

Reported adverse events (FAERS/openFDA)#

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