FDA.reportPublic FDA data

NDC 72603-193-01 - 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
72603-193
Requested NDC
72603-193-01
Package NDCs from labels
72603-193-01, 72603-193-30
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
72603-193-01Sapropterin dihydrochloride1 in 1 PACKETPOWDER, FOR SOLUTION13
72603-193-30Sapropterin dihydrochloride30 in 1 CARTONPOWDER, FOR SOLUTION303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-193SAPROPTERIN 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
72603-193-01EA - Each72603-1930a570cf8-98d4-4f00-ba40-6405307ab01412024-07-12
72603-193-30EA - Each72603-19365108001-cbfe-4850-917b-186fa6156ec612023-12-05

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 5 of 14 · 269 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LunaviraMULTIVITAMINOncora Pharma, LLC474780d5-dd88-8f1a-e063-6294a90a03dc2025-12-31Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
GestyraASCORBIC ACID, CHOLECALCIFEROL, THIAMINE, PYRIDOXAL PHOSPHATE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS GLUCONATE, POTASSIUM IODIDEOncora Pharma LLCf10bf225-c125-4711-893a-78e15be815bb2025-12-30WarningsExact identifier
unii: PQ6CK8PD0R
TRICONTRICONNnodum Pharmaceuticalsd891ab47-4a05-4b5b-b372-7ddf91699c292025-12-29Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Potassium CitratePOTASSIUM CITRATEANI Pharmaceuticals, Inc.2fb31727-68b1-4183-947d-00e08bf999872025-12-22Warnings, Adverse reactionsExact identifier
unii: EE90ONI6FF
STYE EYE RELIEF SERUMVITAMIN EGuangzhou Mizi Biotechnology Co., LTD.3f60193e-4b95-6759-e063-6394a90a991c2025-12-17WarningsExact identifier
unii: PQ6CK8PD0R
Ascorbic AcidASCORBIC ACIDFresenius Kabi USA, LLC1606e29f-0e80-4069-b688-daab9cbff20a2025-12-17Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Potassium CitratePOTASSIUM CITRATEBiocomp Pharma, Inc.b32fe71a-4a58-04a1-64d3-bc3cc4a895bf2025-12-16Warnings, Adverse reactionsExact identifier
unii: EE90ONI6FF
JBA Verestor Mega Fiber PowderVITAMIN C,VITAMIN E,INULIN,BANANA STEM EXTRACT,NATTOKINASE,HOUTTUYNIA CORDATA EXTRACT,RUTIN,BETA-CAROTENEAdvanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticalse7b861da-3851-4a75-b707-4a427c938ee12025-11-28WarningsExact identifier
unii: PQ6CK8PD0R
GLUTATHIONEKOJIC ACIDSKIN LIGHTENINGHANCHOYEANBIOTEC Co.,Ltd.2be274be-e6d0-d961-e063-6294a90a21902025-11-27WarningsExact identifier
unii: PQ6CK8PD0R
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Potassium CitratePOTASSIUM CITRATEBryant Ranch Prepackebf1f1f1-4458-4d34-8432-21698a550e072025-11-04Warnings, Adverse reactionsExact identifier
unii: EE90ONI6FF
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
POTASSIUM CITRATE EXTENDED RELEASEPOTASSIUM CITRATEBryant Ranch Prepack3dd9c9eb-df19-4ec9-bc77-f3a159b33d942025-10-23Warnings, Adverse reactionsExact identifier
unii: EE90ONI6FF
POTASSIUM CITRATEPOTASSIUM CITRATEBryant Ranch Prepackb3ccba22-48cd-45f8-8c72-b80f34fe56be2025-10-23Warnings, Adverse reactionsExact identifier
unii: EE90ONI6FF
Super vitamin C serumSUPER VITAMIN CFlexiGo Inc41cbe84e-3ddf-b806-e063-6294a90a55a42025-10-22WarningsExact identifier
unii: PQ6CK8PD0R
M-Natal PlusVITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, THIAMINE, RIBOFLAVIN, NIACIN, VITAMIN B6, FOLIC ACID, VITAMIN B12, CALCIUM, IRON, ZINC, COPPERMETHOD PHARMACEUTICALS, LLC1f8785db-3e65-49d7-b017-b1a65b5ec6b12025-10-21WarningsExact identifier
unii: PQ6CK8PD0R
Multi-Vitamin Drops with Fluoride and IronVITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FERROUS SULFATE AND SODIUM FLUORIDEMethod Pharmaceuticals, LLCd5609742-e456-4409-bca9-706b0ea90d352025-10-21Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R

Reported adverse events (FAERS/openFDA)#

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