FDA.reportPublic FDA data

NDC 72603-620-01 - Formoterol fumarate

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
72603-620
Requested NDC
72603-620-01
Package NDCs from labels
72603-620-01, 72603-620-30, 72603-620-04, 72603-620-60
Manufacturer
NorthStar RxLLC | Mankind Pharma Limited
Effective date
2026-05-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Formoterol fumarate - NorthStar RxLLC | Mankind Pharma LimitedNorthStar RxLLC | Mankind Pharma Limited2026-05-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72603-620-01Formoterol fumarate2 mL in 1 VIALSOLUTION22
72603-620-01Formoterol fumarate1 in 1 POUCHSOLUTION12
72603-620-04Formoterol fumarate4 in 1 POUCHSOLUTION42
72603-620-04Formoterol fumarate2 mL in 1 VIALSOLUTION22
72603-620-30Formoterol fumarate30 in 1 CARTONSOLUTION302
72603-620-60Formoterol fumarate60 in 1 CARTONSOLUTION602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-620FORMOTEROL FUMARATE (FORMOTEROL FUMARATE DIHYDRATE) SOLUTION [NORTHSTAR RXLLC]1Current NDC, 6 package rows20240701_4dbb9620-5731-40d9-8258-2977ecc781c4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-620-01ML - Milliliter72603-620572b58d9-1f59-410d-b58f-5531e79a55bf12024-08-12
72603-620-04ML - Milliliter72603-6209205e817-1dea-473f-b818-136c9df2d57212024-08-12
72603-620-30ML - Milliliter72603-620794f7eee-01f0-4d5f-a638-3d8e8096b95b12024-08-12
72603-620-60ML - Milliliter72603-6205491b874-747e-4168-a0e5-b480cda1d3a212024-08-12

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 46 of 54 · 1,072 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation2fae04e3-20b1-4b8c-b1fb-646b384836f12022-12-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
MET TOXARSENICUM ALB, AVENA, BERBERIS VULG, LYCOPODIUM, NAT MUR, NUX VOM, PHYTOLACCA, RHAMNUS FRANG, SOLIDAGO, TRIFOLIUM PRATWhite Manufacturing Inc. DBA Micro-West2653d62b-5dd7-482c-b31c-ce5fa13739002022-12-02WarningsExact identifier
unii: 451W47IQ8X
Miranda Castros Healing Gel for Bites and StingsCALENDULA OFFICINALIS, CALADIUM SEGUINUM, LEDUM PALUSTRE, NATRUM MURIATICUM, PLANTAGO MAJOR, STAPHYSAGRIA, URTICA URENS.OHM PHARMA INC.8e06aaa4-c177-45cf-9d8d-e0099de256682022-12-02WarningsExact identifier
unii: 451W47IQ8X
Yonis BlissCHAMOMILLA, NATRUM MURIATICUMBrookhaus Essentials LLCea4091d6-d295-41a0-aae5-68f3c260e1102022-11-30WarningsExact identifier
unii: 451W47IQ8X
4 Kids Cold and Mucus NighttimeEUPHRASIA STRICTA,SILICON DIOXIDE, RUMEX CRISPUS ROOT, ANEMONE PULSATILLA, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CALCIUM SULFIDE AND SULFURHyland's Inc.6f7b2585-2f0e-5938-e053-2a91aa0aa9d12022-11-21WarningsExact identifier
unii: 451W47IQ8X
4 Kids Complete Cold and MucusBRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDEHyland's Inc.ef39fe3d-a42d-4baa-9199-91f664feb4322022-11-21WarningsExact identifier
unii: 451W47IQ8X
Multiple Electrolytes pH 7.4SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDEFresenius Kabi USA, LLC84221110-b3f1-42f4-800c-ad1d3b330e9e2022-11-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Multiple Electrolytes pH 5.5SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDEFresenius Kabi USA, LLCcf1f5f15-d31d-4a02-8f7e-b289d5ad4b5c2022-11-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Natrum MuriaticumNATRUM MURIATICUMHahnemann Laboratories, INC.ecf06f13-012c-212d-e053-2995a90a71982022-11-08Exact identifier
unii: 451W47IQ8X
Sodium Citrate Blood-Pack Units, (PL 146 Plastic)ANTICOAGULANT SODIUM CITRATE SOLUTIONFenwal, Inc.14b238ab-904b-45dc-9eb9-a1074364e0892022-11-07Exact identifier
unii: B22547B95K
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 PlasticANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTIONFenwal, Inc.d55cb701-9664-4931-8754-1a8cae68da062022-11-01Exact identifier
unii: B22547B95K
Budesonide and formoterol fumarate dihydrateBUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATETeva Pharmaceuticals, Inc.dd352302-e2fe-4388-b4b0-00b34f6ebe482022-11-01Warnings, Adverse reactionsExact identifier
unii: W34SHF8J2K
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) SOLUTIONFenwal, Inc.f9d7f1b4-7a77-44f9-8924-10b16008b49d2022-11-01Exact identifier
unii: B22547B95K
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 PlasticANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD)Fenwal, Inc.4a08a9ec-46a5-4fcf-80ee-5c33f1a8b7462022-11-01Exact identifier
unii: B22547B95K
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC51da05ce-e3c4-4ef5-a845-dc869152e17f2022-10-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dr Talbots Infant Daily Allergy ReliefALLIUM CEPA 12X,ARALIA RACEMOSA 12X,EUPHRASIA OFFICINALIS 12X,GALPHIMIA GLAUCA 12X,HISTAMINUM HYDROCHLORICUM 12X,LUFFA OPERCULATA 12X,PULSATILLA 12X,SOLIDAGO 12X,NATRUM MURIATICUM 6XTalbot's Pharmaceuticals Family Products,LLC.e8bdcc8a-c947-ff5d-e053-2a95a90a3b922022-09-12WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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