FDA.reportPublic FDA data

Formoterol fumarate

Product NDC
70756-608
11-digit product format
707560608
Labeler code
70756
Product ID
70756-608_7b9fb2fd-635e-47d6-91f3-b1fca2b9dc2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Formoterol fumarate dihydrate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Lifestar Pharma LLC
Application
ANDA215883
Marketing category
ANDA
Marketing start
2023-03-22
Substance
FORMOTEROL FUMARATE
Active strength
20 ug/2mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Formoterol fumarate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FORMOTEROL FUMARATE20 ug/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW34SHF8J2K
Rxcui1246319

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0c06c4f4-ea2d-4e6a-a22a-0cf292716367Product name420250303
9ab9f611-cedd-47ea-a83c-0489c8c04fc6Product name120231006
a03aea00-1d8b-bfad-a82e-f52f68676f63Product name220221216
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9aProduct name120210204
1cbe9071-502b-482d-9c24-839b43446576Product name120200123
58f15a44-d9d2-4d61-a39d-7f0223302a8fProduct name120190702
ce066c73-ca6f-49fc-83d4-d3cf6728e8a1Product name120160616

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70756-608-12Formoterol fumarate2 mL in 1 VIALSOLUTION210
70756-608-12Formoterol fumarate1 in 1 POUCHSOLUTION110
70756-608-44Formoterol fumarate2 mL in 1 VIALSOLUTION210
70756-608-44Formoterol fumarate4 in 1 POUCHSOLUTION410
70756-608-60Formoterol fumarate60 in 1 CARTONSOLUTION6010
70756-608-70Formoterol fumarate30 in 1 CARTONSOLUTION3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-608-12ML - Milliliter70756-6089fda2065-e352-45b8-9dea-15d7022c8d2712023-06-06
70756-608-44ML - Milliliter70756-6087ecdbee2-2036-447b-a95f-db792ccdb1e612026-05-22
70756-608-60ML - Milliliter70756-60869b6b8b2-edd2-47bc-821f-e509b7e0bc9c12023-05-05
70756-608-70ML - Milliliter70756-608eb2bb37d-7184-4db9-a953-e48522a5a82d12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-608FORMOTEROL FUMARATE (FORMOTEROL FUMARATE DIHYDRATE) SOLUTION [LIFESTAR PHARMA LLC]9Current NDC, 6 package rows20250419_35538d89-a984-4335-acdf-85a893f51eee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1246319formoterol fumarate 20 MCG in 2 ML Inhalation SolutionPSN35538d89-a984-4335-acdf-85a893f51eee10
1246319formoterol fumarate 0.01 MG/ML Inhalation SolutionSCD35538d89-a984-4335-acdf-85a893f51eee10
1246319formoterol fumarate 20 MCG per 2 ML Inhalation SolutionSY35538d89-a984-4335-acdf-85a893f51eee10
1246319formoterol fumarate 20 MCG/2 ML Inhalation SolutionSY35538d89-a984-4335-acdf-85a893f51eee10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70756-608-12707560608122 mL in 1 VIAL2 mlHistorical
70756-608-44707560608442 mL in 1 VIAL2 mlHistorical
70756-608-607075606086060 POUCH in 1 CARTON (70756-608-60) / 4 VIAL in 1 POUCH (70756-608-44) / 2 mL in 1 VIAL60 pouch2023-03-22NoNoCurrent
70756-608-707075606087030 POUCH in 1 CARTON (70756-608-70) / 1 VIAL in 1 POUCH (70756-608-12) / 2 mL in 1 VIAL30 pouch2023-03-22NoNoCurrent