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 75 of 182 · 3,631 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief GelTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF GELClarion Brands LLC445db02a-c8e8-6ebb-e063-6294a90a43012025-11-24WarningsExact identifier
unii: LKG8494WBH
Natural Eyes Floaters ReliefCHELIDONIUM, EUPHRASIA, KALI SULPH, NATRUM MURIATICUM, PHOSPHORUS, PHYSOSTIGMA, SEPIA, SILICEATRP Company445dc831-195e-4b25-e063-6294a90a6efd2025-11-24WarningsExact identifier
unii: 451W47IQ8X
Lights SwabsticksISOPROPYL ALCOHOLLights Medical Manufacture Co., Ltd.4435a4e6-46ae-f49b-e063-6394a90a1d9e2025-11-22WarningsExact identifier
application number: M003
rxcui: 797544
unii: ND2M416302
FloraMedis Hand SanitizerHAND SANITIZERSichuan Pengtai Qifan Technology Co., Ltd4415ca9f-10b1-88f7-e063-6294a90a2e092025-11-21WarningsExact identifier
application number: M003
Leuprolide AcetateLEUPROLIDE ACETATEVGYAAN Pharmaceuticals LLCbec9077a-3f04-4887-856d-dde2de24584d2025-11-21Warnings, Adverse reactionsExact identifier
application number: ANDA213829
rxcui: 545835
rxcui: 797544
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
AMERIDERMBZKSHIELD LINE LLC440b711a-de12-2d28-e063-6394a90ae42a2025-11-20WarningsExact identifier
application number: M003
Recens FoamALCOHOLCertus Medical, Inc.ea384dfc-c894-3124-e053-2a95a90a81c22025-11-20WarningsExact identifier
application number: M003
Scent Theory Hand Sanitizer (Peach Peony, Dragonfruit Paradise, Coastal Fleur)ALCOHOLScent Theory Products LLC440f0a52-de0a-8f44-e063-6294a90a18b52025-11-20WarningsExact identifier
application number: M003
MK Alcohol Prep Pads LargeISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltdf1ff70d7-d0f2-45db-96e9-883b54c6e4412025-11-20WarningsExact identifier
application number: M003
rxcui: 797544
unii: ND2M416302
Vital Female Sexual EnergyAGNUS CASTUS, ARNICA MONTANA, AVENA SATIVA, CAULOPHYLLUM THALICTROIDES, CINCHONA OFFICINALIS, DAMIANA, HYPOPHYSIS SUIS, L-ARGININE, NATRUM MURIATICUM, ONOSMODIUM VIRGINIANUM, OOPHORINUM SUIS, PHOSPHORICUM ACIDUM, SEPIA, THUJA OCCIDENTALISLiddell Laboratories, Inc.1ca43c82-62b0-4191-81a4-27f7f94109dd2025-11-20WarningsExact identifier
unii: 451W47IQ8X
Aero Care Handy Quat Antiseptic HandwashBENZALKONIUM CHLORIDEABC Compounding Co., Inc.ab015f59-160a-47d1-8d2f-fbe1b23177b32025-11-19WarningsExact identifier
application number: M003
Sodium ChlorideSODIUM CHLORIDEWalgreen Companyd112a344-33cc-41d3-bae6-492631ebdba72025-11-19WarningsExact identifier
unii: 451W47IQ8X
FastALCOHOLABC Compounding Co., Inc.4f958247-5370-4250-b2eb-39faa97199392025-11-19WarningsExact identifier
application number: M003
Hydrogen Peroxide1169 HYDROGEN PEROXIDE SPRAYDynarex Corporation11854afb-db97-5a43-e063-6394a90aa39c2025-11-19WarningsExact identifier
application number: M003
Sani-SpritzALCOHOLABC Compounding Co., Inc.ac88c676-c396-4fb8-9e5c-77c726ed69d82025-11-19WarningsExact identifier
application number: M003
Dukal Alcohol Prep PadISOPROPYL ALCOHOLDukal LLC953b0dd6-a667-4146-815e-6845aba0309b2025-11-19WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Osceola Supply Inc 6176CHLOROXYLENOLOSCEOLA SUPPLY, INC.a7dcc6b1-655d-41b3-ab97-913bc4aae01f2025-11-19WarningsExact identifier
application number: M003
Dukal Sterile Alcohol SwabstickISOPROPYL ALCOHOLDukal LLC8e47e9ad-cea4-76a4-e053-2a95a90ae7802025-11-19WarningsExact identifier
rxcui: 797544
unii: ND2M416302
AMERISILKBZKSHIELD LINE LLC43f9775c-0448-243e-e063-6294a90a9e222025-11-19WarningsExact identifier
application number: M003

Reported adverse events (FAERS/openFDA)#

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