FDA.reportPublic FDA data

Albuterol

Product NDC
69238-1344
11-digit product format
692381344
Labeler code
69238
Product ID
69238-1344_efcb5cab-b9c0-4ef9-84fc-5f321c13a0ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA208804
Marketing category
ANDA
Marketing start
2018-05-24
Substance
ALBUTEROL SULFATE
Active strength
2 mg/1
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
Albuterol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBUTEROL SULFATE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii021SEF3731
Rxcui197316, 197318

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
26005090-31a1-441d-920b-db3101a55d53Product name320250221
1c39b897-7219-42a1-9f3a-ec86cfd7b04bProduct name320250218
0a278166-c8aa-41b6-b4a5-6ac332bde76aProduct name120230718
c76bcd0f-25eb-471e-b970-1956c95c26c5Product name120230425
36390b75-5438-47d3-af60-732a654e9025Product name220220110
387afa72-0c5a-0d6b-ee2c-60c3506659e8Product name620210518
1b8ea3ec-88bd-98ea-c961-00ae340b5b14Product name220200220
3aa5a017-61e9-0c89-adef-13e7964d22f0Product name320171208
c3c27a99-b8bc-4955-841c-26555f58ee7eProduct name120150421
bc98cf6f-a973-7162-5e30-0e7dd8c56bc3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1344-1Albuterol100 in 1 BOTTLETABLET1007
69238-1344-5Albuterol500 in 1 BOTTLETABLET5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1344-1EA - Each69238-134429bb6679-5fac-4f19-876b-f576ef9db7de12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1344ALBUTEROL TABLET [AMNEAL PHARMACEUTICALS NY LLC]6Current NDC, Legacy NDC, 2 package rows20241220_230d66fc-f62c-42a6-adb3-0a0f879c8ad4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197316albuterol 2 MG Oral TabletPSN230d66fc-f62c-42a6-adb3-0a0f879c8ad47
197318albuterol 4 MG Oral TabletPSN230d66fc-f62c-42a6-adb3-0a0f879c8ad47
197316albuterol 2 MG Oral TabletSCD230d66fc-f62c-42a6-adb3-0a0f879c8ad47
197318albuterol 4 MG Oral TabletSCD230d66fc-f62c-42a6-adb3-0a0f879c8ad47
197316albuterol 2 MG (as albuterol sulfate 2.4 MG) Oral TabletSY230d66fc-f62c-42a6-adb3-0a0f879c8ad47
197318albuterol 4 MG (as albuterol sulfate 4.8 MG) Oral TabletSY230d66fc-f62c-42a6-adb3-0a0f879c8ad47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1344-169238134401100 TABLET in 1 BOTTLE (69238-1344-1) 100 tablet2018-05-24NoNoCurrent
69238-1344-569238134405500 TABLET in 1 BOTTLE (69238-1344-5) 500 tablet2018-05-240000-00-00NoNoCurrent