FDA.reportPublic FDA data

NDC 43598-477-11 - 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
43598-477
Requested NDC
43598-477-11
Package NDCs from labels
43598-477-11, 43598-477-30
Manufacturer
Dr. Reddys Laboratories Inc | Dr. Reddys Laboratories Limited (SEZ UNIT)
Effective date
2024-08-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sapropterin Dihydrochloride - Dr. Reddys Laboratories Inc | Dr. Reddys Laboratories Limited (SEZ UNIT)Dr. Reddys Laboratories Inc | Dr. Reddys Laboratories Limited (SEZ UNIT)2024-08-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-477-11EA - Each43598-47765021f2a-f1de-4221-bef9-b62ce188907112021-05-05
43598-477-30EA - Each43598-4772ebbfc37-012e-48b4-8612-96e17079c60612021-05-05

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 6 of 14 · 270 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DMethod Pharmaceuticals, LLC42ed15a5-aad6-4ab3-b95b-f9534a419f402025-10-21Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DMethod Pharmaceuticals, LLC71698332-4ab1-4cbb-a98d-1694b715924b2025-10-21Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DMethod Pharmaceuticals, LLCa5af0d8e-5d83-40bb-8df5-3af7277d72cf2025-10-21Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Multi-Vitamin with FluorideVITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, CYANOCOBALAMIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE AND SODIUM FLUORIDEMethod Pharmaceuticals, LLC880df628-5bba-4dc4-b557-1fcc822adba82025-10-21Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Multi-Vitamin with FluorideVITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, CYANOCOBALAMIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE AND SODIUM FLUORIDEMethod Pharmaceuticals, LLCfe1e8e8a-0902-4598-bb06-fe5163c1cffb2025-10-21Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Tri-Vite Drops with FluorideASCORBIC ACID, SODIUM FLUORIDE, VITAMIN A AND VITAMIN DMethod Pharmaceuticals, LLC003181d4-5412-4ffe-b99d-880f2010e3ad2025-10-21Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Tri-Vite Drops with FluorideASCORBIC ACID, SODIUM FLUORIDE, VITAMIN A AND VITAMIN DMethod Pharmaceuticals, LLC5acff360-8d44-44d7-864d-52f213501d032025-10-21Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
LumavexMULTIVITAMINOncora Pharma, LLC4139742d-d091-121c-e063-6394a90a62212025-10-15Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
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.8c3e961d-bc33-40cd-a282-a4fe5aa3f0ad2025-10-06WarningsExact identifier
unii: PQ6CK8PD0R
VirexaVITAMIN C, VITAMIN D3, VITAMIN B1, VITAMIN B6, VITAMIN B12, FOLIC ACID, NADH, UBIQUINONEOncora Pharma, LLC3e16048d-d852-563e-e063-6394a90a66002025-09-05WarningsExact identifier
unii: PQ6CK8PD0R
Multivitamin with FluorideSODIUM FLUORIDEWINDER LABORATORIES, LLCa10ff759-eba7-414b-bb98-f17fbb6e6b572025-08-27Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Skin Renewing SerumASCORBIC ACIDGuangzhou Danting Bath&Body Care Industry Co. Ltd396c2a8d-ac95-cbef-e063-6294a90aff392025-08-23WarningsExact identifier
unii: PQ6CK8PD0R
POTASSIUM CITRATE EXTENDED RELEASEPOTASSIUM CITRATEBryant Ranch Prepack44ab2c4f-4a76-470d-98fb-8874c692a9672025-08-20Warnings, Adverse reactionsExact identifier
unii: EE90ONI6FF
Pediatric Infuvite Multiple VitaminsASCORBIC ACID, VITAMIN A PALMITATE, CHOLECALCIFEROL, THIAMINE HYDROCHLORIDE, RIBOFLAVIN-5 PHOSPHATE SODIUM, PYRIDOXINE HYDROCHLORIDE, NIACINAMIDE, DEXPANTHENOL, ALPHA-TOCOPHEROL ACETATE, VITAMIN K1, FOLIC ACID, BIOTIN, CYANOCOBALAMINSandoz Inc4ff223f7-e076-4e81-8151-5c06724fabd92025-08-18Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
EmbrivaASCORBIC ACID, CHOLECALCIFEROL, THIAMINE, PYRIDOXAL PHOSPHATE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS GLUCONATE, POTASSIUM IODIDEOncora Pharma, LLC3c362de4-1ed9-83be-e063-6394a90a10fc2025-08-12WarningsExact identifier
unii: PQ6CK8PD0R
Potassium CitratePOTASSIUM CITRATEUpsher-Smith Laboratories, LLC2215dc1d-0b5a-469e-9b51-4d7480a510782025-07-14Warnings, Adverse reactionsExact identifier
unii: EE90ONI6FF
FlotrexMULTIVITAMINS, SODIUM FLUORIDE 0.5 MGPureTek Corporation2e0e51f3-ee2c-540d-e063-6294a90a92752025-07-14Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
FlotrexMULTIVITAMINS, SODIUM FLUORIDE 0.25 MGPureTek Corporation30186998-2121-3ef2-e063-6394a90a513e2025-07-14Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
FlotrexMULTIVITAMINS, SODIUM FLUORIDE 1 MGPureTek Corporation399c637c-0e25-9b11-e063-6294a90a4c282025-07-10Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R

Reported adverse events (FAERS/openFDA)#

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