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 46 of 57 · 1,124 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Grain and Seed AntigensAMARANTH, BAMBOO, BARLEY, BUCKWHEAT, CORN, FLAX SEED, LENTILS, MILLET, MILO, OAT, POPPY SEED, RICE, RYE, SESAME, SOYBEAN, SUGARCANE, SUNFLOWER SEED, WHEAT, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHURBioActive Nutritional, Inc.36ce44a5-e5ac-4eea-b76d-424dcd4e6b072023-06-20WarningsExact identifier
unii: 451W47IQ8X
Vital Skin Hair NailsL-ALANINE, L-ARGININE, L-CARNITINE, CYSTEINUM, L-GLUTAMINE, L-HISTIDINE, L-ISOLEUCINE, L-LEUCINE, L-LYSINE, L-METHIONINE, L-ORNITHINE, L-PROLINE, L-SERINE, L-TRYPTOPHAN, L-TYROSINE, L-VALINE, APIS MELLIFICA, BIOTIN, EPIDERMIS SUIS, GALIUM APARINE, HAMAMELIS VIRGINIANA, HEPAR SUIS, HGH, HYPOPHYSIS SUIS, NATRUM MURIATICUM, PANTOTHENIC ACID, PHOSPHORICUM ACIDUM, RIBOFLAVINUM, THUJA OCCIDENTALISLiddell Laboratories, Inc.3e8a9233-6e65-4023-b3f8-8bca369a9c2a2023-06-15WarningsExact identifier
unii: 451W47IQ8X
Endopar FCIMICIFUGA RACEMOSA, FUCUS VESICULOSUS, OOPHORINUM (SUIS), HYPOPHYSIS SUIS, THYROIDINUM (SUIS), GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), SEPIAEnergique, Inc.d186ae0e-0dc3-48e7-9e22-6778bb80ad182023-06-07WarningsExact identifier
unii: 451W47IQ8X
Cyclease PMSESTRONE, SODIUM CHLORIDE, SEPIA OFFICINALIS JUICELaboratoires Boiron09ff0633-2992-4aba-96ed-45a69f3ee5892023-05-30WarningsExact identifier
unii: 451W47IQ8X
BACTERIOSTATIC SODIUM CHLORIDESODIUM CHLORIDEMedical Purchasing Solutions, LLC8a0d24a9-d02a-0379-e053-2a95a90af7122023-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Histastat PollenBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), ADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), SABADILLA, SINAPIS NIGRA, SOLIDAGO VIRGAUREA, SULPHUR, WYETHIA HELENIOIDESEnergique, Inc.00478787-ccec-4101-a0da-fd337037c3ee2023-05-12WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Natrum MuriaticumNATRIUM MURIATICUMTrue Botanica, LLC7d2d9129-8683-484d-e053-2a91aa0a6f8f2023-05-01WarningsExact identifier
unii: 451W47IQ8X
CosmestatALFALFA, AVENA SATIVA, IODIUM, BOVISTA, FORMALINUM, HYPOPHYSIS SUIS, MANGANUM ACETICUM, NATRUM MURIATICUM, PETROLEUM, PULSATILLA (PRATENSIS), RHUS TOX, TEREBINTHINA, THYROIDINUM (BOVINE), CORTISONE ACETICUMEnergique, Inc.edc8eb65-84b3-433f-8aad-7a741f5637182023-04-17WarningsExact identifier
unii: 451W47IQ8X
Baby Nighttime Mucus Plus Cold ReliefCALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLAHyland's Inc.736b2487-e81d-d172-e053-2a91aa0ab0cf2023-04-17WarningsExact identifier
unii: 451W47IQ8X
RadialginCITRUS LIMONUM, FUCUS VESICULOSUS, HYDRANGEA ARBORESCENS, SODIUM ALGINATE, NATRUM MURIATICUM, PHOSPHORUS, AGATE, RADIUM BROMATUM, X RAYNutritional Specialties, Inc.f1414ae2-4068-4076-bf11-b57a34ba5df22023-04-12WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlutenstatALFALFA, ZINGIBER OFFICINALE, CINCHONA OFFICINALIS, HYDRASTIS CANADENSIS, BARLEY (GRAIN), CARBO VEGETABILIS, GLYPHOSATE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, OAT (GRAIN), PULSATILLA (VULGARIS), RYE (GRAIN), WHEAT (GRAIN), GLUTENEnergique, Inc.c6b867b6-74d9-4725-90d7-7d5d1fe611212023-04-05WarningsExact identifier
unii: 451W47IQ8X
AnxietyBORAX, NATRUM MURIATICUM, CAUSTICUM, ELETTARIA CARDAMOMUM, PLUMBUM METALLICUM, SEPIA, LILIUM TIGRINUM, OXYTROPIS LAMBERTIINutritional Specialties, Inc.657ed32f-3ac7-4806-96b4-4c7aa0f65e7f2023-04-03WarningsExact identifier
unii: 451W47IQ8X
Virility LiquescenceAVENA SATIVA, DAMIANA, BERBERIS VULGARIS, EPIMEDIUM GRANDIFLORUM, GLYCERINUM, SABAL SERRULATA, IODIUM, LECITHIN, FERRUM MURIATICUM, NATRUM MURIATICUM, AGNUS CASTUS, BUFO RANA, CINCHONA OFFICINALIS, HUMAN GROWTH HORMONE (HGH), ORCHITINUM (BOVINE), PHOSPHORICUM ACIDUM, PHOSPHORUS, SELENIUM METALLICUM, ZINCUM VALERIANICUM, OOPHORINUM (SUIS), SEPIANutritional Specialties, Inc.81cc3e2b-f95e-4ba4-a15f-c07b4def0e2f2023-03-29WarningsExact identifier
unii: 451W47IQ8X
Spleen Thymus LiquescenceCINCHONA OFFICINALIS, QUERCUS GLANDIUM SPIRITUS, CEANOTHUS AMERICANUS, SPLEEN (BOVINE), THYMUS (BOVINE), CHININUM ARSENICOSUM, NATRUM MURIATICUM, HELIANTHUS ANNUUSNutritional Specialties, Inc.bc1cc31e-0e8a-49a2-9654-f00eaa72fc042023-03-24WarningsExact identifier
unii: 451W47IQ8X
BEVESPI AEROSPHEREGLYCOPYRROLATE AND FORMOTEROL FUMARATEAstraZeneca Pharmaceuticals LPae02436e-9528-490e-a844-0c0f6f2843f92023-03-24Warnings, Adverse reactionsExact identifier
unii: W34SHF8J2K
Emetrol Chewables Mixed BerrySODIUM CITRATE DIHYDRATEWellSpring Pharmaceutical Corporation4965fab0-828d-4f1d-8d43-a636e0a8c1ea2023-03-23WarningsExact identifier
unii: B22547B95K

Reported adverse events (FAERS/openFDA)#

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