FDA.reportPublic FDA data

NDC 62332-655-01 - 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
62332-655
Requested NDC
62332-655-01
Package NDCs from labels
62332-655-01, 62332-655-30, 62332-655-60
Manufacturer
Alembic Pharmaceuticals Inc. | Rommelag CDMO GmbH
Effective date
2025-12-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Formoterol Fumarate - Alembic Pharmaceuticals Inc. | Rommelag CDMO GmbHAlembic Pharmaceuticals Inc. | Rommelag CDMO GmbH2025-12-23Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-655-01Formoterol Fumarate2 mL in 1 VIALSOLUTION212
62332-655-01Formoterol Fumarate1 in 1 POUCHSOLUTION112
62332-655-30Formoterol Fumarate30 in 1 CARTONSOLUTION3012
62332-655-60Formoterol Fumarate1 in 1 POUCHSOLUTION112
62332-655-60Formoterol Fumarate60 in 1 CARTONSOLUTION6012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-655FORMOTEROL FUMARATE SOLUTION [ALEMBIC PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 5 package rows20250207_07afdf7e-c480-4806-b469-a6a460522bc0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-655-01ML - Milliliter62332-6558d83b796-16a2-4fcc-82e7-50d53b8dd28a12022-03-09
62332-655-30ML - Milliliter62332-655c44f1035-778c-4ce1-91b5-e5f9124e151412022-03-09
62332-655-60ML - Milliliter62332-65559f28dc4-24d8-44af-ad2e-2f6a66a0b15b12022-03-09

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 31 of 57 · 1,124 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a78060-7f0d-c4bd-e063-6294a90ae1522025-01-15WarningsExact identifier
unii: 2968PHW8QP
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a78a5c-e3b5-f362-e063-6394a90a08072025-01-15WarningsExact identifier
unii: 2968PHW8QP
D-43ARSENIC TRIOXIDE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, ACTIVATED CHARCOAL, BOS TAURUS PITUITARY GLAND, POSTERIOR, SODIUM SULFATE, VERATRUM ALBUM ROOT, ERIODICTYON CALIFORNICUM LEAF, SODIUM CHLORIDE, AND DIBASIC POTASSIUM PHOSPHATEDNA Labs, Inc.937e2b7e-4001-402f-bd12-dcff4627e9282025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-78HYPERICUM PERFORATUM, LACHESIS MUTA VENOM, LYTTA VESICATORIA, ECHINACEA ANGUSTIFOLIA, SODIUM CHLORIDE, AND PLANTAGO MAJORDNA Labs, Inc.d62673a9-8a67-4580-a8bf-25f85960a5552025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-86ARNICA MONTANA, SILICON DIOXIDE, SODIUM CHLORIDE, LEAD ACETATE ANHYDROUS, SELENICEREUS GRANDIFLORUS STEM, TRIBASIC CALCIUM PHOSPHATE, AND POTASSIUM IODIDEDNA Labs, Inc.54fa62d3-c129-4826-a794-f3dcc6b855bf2025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-98STRYCHNOS NUX-VOMICA SEED, MATRICARIA CHAMOMILLA, ANEMONE PRATENSIS, SODIUM CHLORIDE, CALCIUM SULFIDE, GOLD, DAPHNE MEZEREUM BARK, PLATINUM, AND BERBERIS VULGARIS ROOT BARKDNA Labs, Inc.9b39b277-9eb2-44c9-9c0c-a8680a50e18d2025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-129SODIUM CHLORIDEDNA Labs, Inc.ef130f08-1c34-4774-9298-2d1997e631fc2025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-50HORSE CHESTNUT, CITRULLUS COLOCYNTHIS FRUIT PULP, BLACK COHOSH, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, AND STRONTIUM CARBONATEDNA Labs, Inc.df118b9b-dee7-4555-bcae-751007c1fd2c2025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-68CROTON OIL, DAPHNE MEZEREUM BARK, SODIUM CHLORIDE, AND TOXICODENDRON PUBESCENS LEAFDNA Labs, Inc.01ae098b-aadd-4edc-bf73-6bc60903e7792025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-53AMMONIUM BROMIDE, BROMINE, CALCIUM SULFIDE, POTASSIUM BROMIDE, RHODODENDRON TOMENTOSUM LEAFY TWIG, SODIUM BROMIDE, SODIUM CHLORIDE, AND BOS TAURUS PLACENTADNA Labs, Inc.3787d569-ee4d-41de-9519-73c11b626b382025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-51ATROPA BELLADONNA, IODINE, LYCOPUS VIRGINICUS, SODIUM CHLORIDE, HEKLA LAVA, AND CALCIUM HEXAFLUOROSILICATEDNA Labs, Inc.9928dd54-bd3a-47cb-bde5-4bebab3db6832025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-99ATROPA BELLADONNA, NITROGLYCERIN, LACTIC ACID, UNSPECIFIED FORM, SCROPHULARIA NODOSA, ALOE, RADIUM BROMIDE, POTASSIUM IODIDE, SUS SCROFA BONE MARROW, ZINC, AND CITRIC ACID MONOHYDRATEDNA Labs, Inc.dd9c0226-35ea-445a-a570-1ec35551f68d2025-01-13WarningsExact identifier
unii: 2968PHW8QP
D-97ALUMINUM OXIDE, SILVER, SILVER NITRATE, ARSENIC TRIOXIDE, MERCURIUS SOLUBILIS, CALOMEL, MERCURIC IODIDE, LEAD, LEAD IODIDE, CHELIDONIUM MAJUS, ZINC, SOLIDAGO VIRGAUREA FLOWERING TOP, AND CITRIC ACID MONOHYDRATEDNA Labs, Inc.b2079abb-786c-4f92-8d49-5606c77f7d722025-01-13WarningsExact identifier
unii: 2968PHW8QP
D-112LACHESIS MUTA VENOM, SILICON DIOXIDE, SODIUM CHLORIDE, RANUNCULUS BULBOSUS, ACONITUM NAPELLUS, ACTIVATED CHARCOAL, NITROGLYCERIN, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ANEMONE PRATENSIS, PLANTAGO MAJOR, ARSENIC TRIOXIDE, AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEDNA Labs, Inc.8d517ef2-3a1e-4393-9452-a4cd0f0a3bca2025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-65ARSENIC TRIOXIDE, BERBERIS AQUIFOLIUM ROOT BARK, OYSTER SHELL CALCIUM CARBONATE, CRUDE, GRAPHITE, CENTELLA ASIATICA, AND SODIUM CHLORIDEDNA Labs, Inc.94d4b66a-f995-4516-bdcf-2152c2a624dd2025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-88COCCULUS INDICUS, NATRUM MURIATICUM, HELONIAS DIOICA, CALCAREA PHOSPHORICUM, IGNATIA AMARA, MAGNESIA PHOSPHORICUM, CIMICIFUGA RACEMOSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, SEPIA, KALIUM PHOSPHORICUM, ZINCUM METALLICUM, PITUITARY, ADRENAL, OVARIANDNA Labs, Inc.1eefff9c-d86c-44ef-b968-9a8c5a9c54032025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-133CALCIUM FLUORIDE, SILICON DIOXIDE, TRIBASIC CALCIUM PHOSPHATE, CALCIUM SULFATE ANHYDROUS, FERROSOFERRIC PHOSPHATE, POTASSIUM CHLORIDE, DIBASIC POTASSIUM PHOSPHATE, POTASSIUM SULFATE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM CHLORIDE, AND SODIUM SULFATEDNA Labs, Inc.a250b7e9-7fd2-4cb0-82f3-baa089d174412025-01-13WarningsExact identifier
unii: 451W47IQ8X
formoterol fumarateFORMOTEROL FUMARATELupin Pharmaceuticals, Inc.44284e8c-0503-48c4-ae71-a0d6b865665d2025-01-13Warnings, Adverse reactionsExact identifier
rxcui: 1246319
unii: W34SHF8J2K
Premixed saline packetsSODIUM CHLORIDE, SODIUM BICARBONATEShenzhen Kerui lntl Trading Co., Ltd0d11e07b-c137-6efc-e063-6394a90a6bba2025-01-09WarningsExact identifier
unii: 451W47IQ8X
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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