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 3 of 14 · 269 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
M-Natal PlusVITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, THIAMINE, RIBOFLAVIN, NIACIN, VITAMIN B6, FOLIC ACID, VITAMIN B12, CALCIUM, IRON, ZINC, COPPERBryant Ranch Prepack790a9ec0-eb61-4148-86e9-91439e4dce892026-03-27WarningsExact identifier
unii: PQ6CK8PD0R
Potassium CitratePOTASSIUM CITRATEBryant Ranch Prepack6271d84e-d991-4bb8-ac9f-6d5cc879b6312026-03-25Warnings, Adverse reactionsExact identifier
unii: EE90ONI6FF
Potassium CitratePOTASSIUM CITRATEBryant Ranch Prepack595343aa-b760-4158-9c49-dd5368f45e2c2026-03-25Warnings, Adverse reactionsExact identifier
unii: EE90ONI6FF
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepackf28c8928-81c3-458a-9ce2-2aaca3b7527d2026-03-18Warnings, 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 DBryant Ranch Prepackef79cadb-c553-4af1-9a53-6ea1ab26b4bb2026-03-18Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
AdaptagenARALIA QUINQUEFOLIA, AVENA SATIVA, CAPSICUM ANNUUM, GINKGO BILOBA, GLYCYRRHIZA GLABRA, HYDROCOTYLE ASIATICA, THIAMINUM HYDROCHLORICUM, ASCORBICUM ACIDUM, RIBOFLAVINUM, GLANDULA SUPRARENALIS SUIS, SPLEEN (SUIS), THYROIDINUM (SUIS), CUPRUM GLUCONATE, IODIUM, LEDUM PALUSTRE, MOLYBDENUM METALLICUM, NATRUM CARBONICUM, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, SELENIUM METALLICUM, SEPIA, VANADIUM METALLICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUMBioActive Nutritional, Inc.9404d71c-8a2e-4e68-bf48-8536bb14fc882026-03-18WarningsExact identifier
unii: PQ6CK8PD0R
Tri-Vite Drops with FluorideASCORBIC ACID, SODIUM FLUORIDE, VITAMIN A AND VITAMIN DBryant Ranch Prepackfe9da1e9-9b36-4702-bec2-13187f0f65482026-03-18Warnings, Adverse reactionsExact 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, COPPERBryant Ranch Prepackf9f15374-4809-4b96-8a07-3c2f1011d1102026-03-18WarningsExact 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 DBryant Ranch Prepack6607fcec-2da9-47df-ad92-1d545f7bf5352026-03-17Warnings, 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 DBryant Ranch Prepack3c3acbdd-0bcb-4798-b6c5-242bdcd352b12026-03-17Warnings, 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 DBryant Ranch Prepack5568579f-3445-4f04-a936-33c78b33392c2026-03-17Warnings, 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 DBryant Ranch Prepackb7f1c321-5a00-4b89-8cb4-fa250e74d9db2026-03-17Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Sapropterin dihydrochlorideSAPROPTERIN DIHYDROCHLORIDECamber Pharmaceuticals, Inc.3f0d6820-ff59-40c0-882f-aeea2dd1d1ad2026-03-05Warnings, Adverse reactionsExact identifier
application number: ANDA215420
rxcui: 1653217
rxcui: 1111018
unii: RG277LF5B3
OsteoplexEQUISETUM HYEMALE, MAGNESIA MURIATICA, ASCORBICUM ACIDUM, MANGANUM MURIATICUM, SYMPHYTUM OFFICINALE, MEDULLA OSSIS SUIS, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEA, PARATHYROID GLAND (SUIS), LIGAMENT (SUIS)BioActive Nutritional, Inc.8a7e1397-a387-4f2c-ab4f-7f1a7f1a849b2026-03-05WarningsExact identifier
unii: PQ6CK8PD0R
PNV-DHAASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CALCIUM, FERROUS FUMARATE, DOCONEXENTAcella Pharmaceuticals, LLC576e8bbb-1625-493c-85da-43caf2f02e3c2026-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
TricitratesTRICITRATESChartwell Governmental & Specialty RX, LLC.c4ff0407-3930-4c48-afd4-d2cb3e1b18f42026-02-25Warnings, Adverse reactionsExact identifier
unii: EE90ONI6FF
Potassium Citrate and Citric AcidPOTASSIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC.fd57a176-7faf-4053-b348-6ba5f192f05a2026-02-25Warnings, Adverse reactionsExact identifier
unii: EE90ONI6FF
FolartexMULTIVITAMINOncora Pharma, LLC0a4cb0ab-565f-45e8-a989-740bccef21cd2026-02-25Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
sapropterin dihydrochlorideSAPROPTERIN DIHYDROCHLORIDECamber Pharmaceuticals, Inc.ec8ea96c-8ec1-4301-a85d-d59562e548ca2026-02-24Warnings, Adverse reactionsExact identifier
unii: RG277LF5B3
Sapropterin DihydrochlorideSAPROPTERIN DIHYDROCHLORIDETRUPHARMA, LLC39f1d020-4359-401b-88a8-ed25eaa40b452026-02-18Warnings, Adverse reactionsExact identifier
rxcui: 1653217
rxcui: 1111018
unii: RG277LF5B3

Reported adverse events (FAERS/openFDA)#

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