FDA.reportPublic FDA data

NDC 73289-0060-3 - 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
73289-0060
Requested NDC
73289-0060-3
Package NDCs from labels
73289-0060-3, 73289-0060-1, 73289-0060-2
Manufacturer
Aucta Pharmaceuticals, Inc
Effective date
2024-12-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Formoterol Fumarate - Aucta Pharmaceuticals, IncAucta Pharmaceuticals, Inc2024-12-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73289-0060-1ML - Milliliter73289-0060661e1990-3907-4a64-861a-5af1db75060612023-02-06
73289-0060-2ML - Milliliter73289-0060f87378e0-da31-4329-abd5-26316ccef95612023-02-06
73289-0060-3ML - Milliliter73289-006011fa1ca9-5e8e-4f98-a3ce-6156ba67d2a912023-02-06

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 1 of 2 · 31 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DuleraMOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATEOrganon LLC8f399784-f257-4f31-b3dc-368bf2a1864d2026-07-10Warnings, Adverse reactionsExact identifier
unii: W34SHF8J2K
TrimbowBECLOMETHASONE DIPROPIONATE/FORMOTEROL FUMARATE/GLYCOPYRROLATEChiesi USA, Inc.4e13e70f-f550-4603-bbfb-346f80df3c4f2026-05-20Warnings, Adverse reactionsExact identifier
unii: W34SHF8J2K
Formoterol fumarateFORMOTEROL FUMARATE DIHYDRATENorthStar RxLLC4dbb9620-5731-40d9-8258-2977ecc781c42026-05-01Warnings, Adverse reactionsExact identifier
unii: W34SHF8J2K
Formoterol fumarateFORMOTEROL FUMARATE DIHYDRATELifestar Pharma LLC35538d89-a984-4335-acdf-85a893f51eee2026-05-01Warnings, Adverse reactionsExact identifier
unii: W34SHF8J2K
Budesonide and Formoterol Fumarate DihydrateBUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATESportpharm LLCd6cc66c9-6f97-4ea8-a787-30a048004c772026-04-24Warnings, Adverse reactionsExact identifier
unii: W34SHF8J2K
SYMBICORTBUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATESportpharm LLCa645756c-c692-4bc6-a858-7e7e249561bd2026-03-12Warnings, Adverse reactionsExact identifier
unii: W34SHF8J2K
Formoterol FumarateFORMOTEROL FUMARATEAlembic Pharmaceuticals Inc.07afdf7e-c480-4806-b469-a6a460522bc02025-12-23Warnings, Adverse reactionsExact identifier
unii: W34SHF8J2K
Formoterol Fumarate Inhalation SolutionFORMOTEROL FUMARATE DIHYDRATERitedose Pharmaceuticals, LLC2d9bf685-8886-4865-834b-2748af124b792025-12-10Warnings, Adverse reactionsExact identifier
application number: ANDA216486
unii: W34SHF8J2K
BREYNABUDESONIDE AND FORMOTEROL FUMARATEMylan Pharmaceuticals Inc.dc529fc4-bddb-4673-8202-dc401f86166f2025-11-15Warnings, Adverse reactionsExact identifier
unii: W34SHF8J2K
Formoterol FumarateFORMOTEROL FUMARATEIngenus Pharmaceuticals, LLC303479a7-80fb-1f6d-e063-6394a90abbda2025-06-05Warnings, Adverse reactionsExact identifier
unii: W34SHF8J2K
Formoterol fumarateFORMOTEROL FUMARATE DIHYDRATEDevatis, Inc.fd0dac5d-e58c-46ee-9d28-1a1ef7a6be5e2025-04-10Warnings, Adverse reactionsExact identifier
unii: W34SHF8J2K
Formoterol FumarateFORMOTEROL FUMARATEDr. Reddy's Laboratories Inc.2010b5cb-c277-57dd-ed6b-607cad2c45a42025-01-30Warnings, Adverse reactionsExact identifier
unii: W34SHF8J2K
formoterol fumarateFORMOTEROL FUMARATELupin Pharmaceuticals, Inc.44284e8c-0503-48c4-ae71-a0d6b865665d2025-01-13Warnings, Adverse reactionsExact identifier
unii: W34SHF8J2K
2888f4db-2680-f975-e063-6394a90a2bd2ee9f1a77-7943-445d-e053-2a95a90a34e52024-12-05Warnings, Adverse reactionsExact identifier
spl id: 2888f4db-2680-f975-e063-6394a90a2bd2
spl set id: ee9f1a77-7943-445d-e053-2a95a90a34e5
SYMBICORTBUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATEA-S Medication Solutions6b78d08a-e098-4188-8f7f-94fbd5f396ef2024-10-22Warnings, Adverse reactionsExact identifier
unii: W34SHF8J2K
Budesonide and Formoterol Fumarate DihydrateBUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATEA-S Medication Solutionsb974bab9-c6d2-41ad-b930-28f2904c5f9d2024-10-22Warnings, Adverse reactionsExact identifier
unii: W34SHF8J2K
Formoterol fumarateFORMOTEROL FUMARATEMicro Labs Limited0796acea-70d6-479f-af48-18723b1efd2a2024-09-26Warnings, Adverse reactionsExact identifier
unii: W34SHF8J2K
SYMBICORTBUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATEA-S Medication Solutions805764a1-65e1-4117-ac4a-7a54c3986cfe2024-06-28Warnings, Adverse reactionsExact identifier
unii: W34SHF8J2K
SYMBICORTBUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATEA-S Medication Solutions5feb8f35-b237-477a-9836-2a6db2ed6fa72024-04-15Warnings, Adverse reactionsExact identifier
unii: W34SHF8J2K
SYMBICORTBUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATEA-S Medication Solutions52f45e18-463e-4ce3-8ccd-c0260473e6b52024-04-15Warnings, Adverse reactionsExact identifier
unii: W34SHF8J2K

Reported adverse events (FAERS/openFDA)#

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