FDA.reportPublic FDA data

NDC 72603-201 - Leuprolide Acetate

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
72603-201
Package NDCs from labels
72603-201-01
Manufacturer
NorthStar RxLLC | RK Pharma INC
Effective date
2025-06-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Leuprolide Acetate - NorthStar RxLLC | RK Pharma INCNorthStar RxLLC | RK Pharma INC2025-06-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72603-201-01Leuprolide Acetate2.8 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION2.8 mL5 mg in 1mL7
72603-201-01Leuprolide Acetate1 in 1 CARTONINJECTION, SOLUTION5 mg in 1mL7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-201LEUPROLIDE ACETATE KIT [NORTHSTAR RXLLC]5Unmatched20240622_0cf31b40-816b-d055-e063-6294a90af5d0.zip

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 66 of 182 · 3,631 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. Nenninger Cold and Sinus SolutionALLIUM CEPA, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, KALI IODATUM, NATRUM MURIATICUM, PULSATILLANenningers Naturals, LLC1e26b25c-5d93-4f69-aa9e-a187abd6d0352025-12-25WarningsExact identifier
unii: 451W47IQ8X
Normal SaltSODIUM CHLORIDEGRAXCELL PHARMACEUTICAL, LLCf3f09817-8a38-4aa1-956b-69d9cf6950742025-12-25WarningsExact identifier
unii: 451W47IQ8X
MG DermaSan 72ISOPROPYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.cccdefbc-09ef-417f-9b7a-1b254ae6e4382025-12-23WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing Alcohol Lil Drug Store ProductsISOPROPYL ALCOHOLLil' Drug Store Products, Incb55238e0-840a-449b-95be-4b372034c1e32025-12-23WarningsExact identifier
unii: ND2M416302
ActivMendARNICA MONTANA, HYPERICUM PERFORATUM, LEDUM PALUSTRE, RHUS TOXICODENDRON, RUTA GRAVEOLENS, NATRUM MURATICUMCearna, Inc.baefc5d4-a7e4-4ba2-e053-2995a90a4b862025-12-23WarningsExact identifier
unii: 451W47IQ8X
HumiraADALIMUMABCordavis Limited4977567e-3525-44ac-9ff5-f1e74b0539502025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 797544
HumiraADALIMUMABAbbVie Inc.608d4f0d-b19f-46d3-749a-7159aa5f933d2025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 797544
GuardelleBENZALKONIUM CHLORIDESocial Medical Supply LLC8793e3be-7409-4f71-9397-abbeacd27cf82025-12-22WarningsExact identifier
application number: M003
CareALL First Aid Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCLNew World Imports, Inc69eef888-0044-485c-96a1-247ed12048582025-12-22WarningsExact identifier
application number: M003
Hand Sanitizer Pear Blossom TeaALCOHOL SOLUTIONNoshinku46927edb-f8be-f0b9-e063-6294a90a8e562025-12-22WarningsExact identifier
application number: M003
Hand Sanitizer Santal BlancALCOHOL SOLUTIONNoshinku4692c807-268e-6477-e063-6394a90aac0a2025-12-22WarningsExact identifier
application number: M003
Hand Sanitizer Vanilla CremeALCOHOL SOLUTIONNoshinku4692e68c-2bc8-83f8-e063-6294a90a84e42025-12-22WarningsExact identifier
application number: M003
Alcohol sanitizer wipesALCOHOL/PURIFIED WATERSHANDONG HENGFA HYGIENIC PRODUCTS CO., LTD.ab9634bd-4226-2f73-e053-2995a90a802f2025-12-19WarningsExact identifier
application number: M003
Kids Cold and Cough DaytimeCALCIUM SULFIDE,GOLDENSEAL,ONION,PHOSPHORUS,PULSATILLA VULGARIS, SODIUM CHLORIDEHyland's Consumer Health Inc.e6118c79-b6d5-5c09-e053-2a95a90a30cf2025-12-19WarningsExact identifier
unii: 451W47IQ8X
4 KIDS COLD N COUGH GRAPE FLAVORONION, CALCIUM SULFIDE, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, AND SULFURHyland's Inc.798e2a4d-da2d-4bbd-a9b8-574490ef73572025-12-19WarningsExact identifier
unii: 451W47IQ8X
4 Kids Cold and Cough DaytimeONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEALHyland's Inc.804e0e7a-20eb-128b-e053-2991aa0aa82c2025-12-19WarningsExact identifier
unii: 451W47IQ8X
4 Kids Cold and Cough Nighttime Natural Grape FlavorONION,ANEMONE PULSATILLA, PHOSPHORUS, GOLDENSEAL, CALCIUM SULFIDE, SODIUM CHLORIDE, SULFUR, MATRICARIA CHAMOMILLA AND ARABICA COFFEE BEANHyland's Inc.7923e59a-f62c-44df-e053-2991aa0afc1e2025-12-19WarningsExact identifier
unii: 451W47IQ8X
Sanitizing WipesBENZALKONIUM CHLORIDEWipes LLC9e9a76d9-23e0-4d3a-9903-8bf7aba54aa32025-12-19WarningsExact identifier
application number: M003
Hair and Nail TonicAVENA, DNA, ELAEIS, GLANDULA SUPRARENALIS SUIS, HAMAMELIS, HEPAR SUIS, KALI SULPH, NAT MUR, NICOTINAMIDUM, PHOSPHORICUM AC, PITUITARUM POSTERIUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, THUJA OCC, THYROIDINUM, URTICA UR.Eight and Company L.L.C35bda785-b3a7-4928-aaea-27bf9fb6abb52025-12-18WarningsExact identifier
unii: 451W47IQ8X
Hand SanitizerBENZALKONIUM CHLORIDEDGH Pharma, Inc.afeccd10-c7e5-6193-e053-2995a90a9a5a2025-12-18WarningsExact identifier
application number: M003

Reported adverse events (FAERS/openFDA)#

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