FDA.reportPublic FDA data

Albuterol Sulfate

Product NDC
68788-7996
11-digit product format
687887996
Labeler code
68788
Product ID
68788-7996_b4d7b542-5aaa-4a4e-a73a-a2b193715cc8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
Preferred Pharmaceuticals Inc.
Application
NDA020503
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2021-08-10
Substance
ALBUTEROL SULFATE
Active strength
108 ug/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 Sulfate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBUTEROL SULFATE108 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii021SEF3731
Rxcui2123111

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
68788-7996-2Albuterol Sulfate200 in 1 CANISTERAEROSOL, METERED2006
68788-7996-2Albuterol Sulfate1 in 1 CARTONAEROSOL, METERED16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7996-2GM - Gram68788-7996e5aad48e-e92f-4b88-9aab-6de1a5e8c06d12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7996ALBUTEROL SULFATE AEROSOL, METERED [PREFERRED PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 2 package rows20241017_d6acb5a7-555a-463a-ae65-2911d6789b42.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilPSNd6acb5a7-555a-463a-ae65-2911d6789b426
2123111NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCDd6acb5a7-555a-463a-ae65-2911d6789b426
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilSYd6acb5a7-555a-463a-ae65-2911d6789b426

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7996-2687887996021 CANISTER in 1 CARTON (68788-7996-2) / 200 AEROSOL, METERED in 1 CANISTER1 canister2021-08-100000-00-00NoNoCurrent