FDA.reportPublic FDA data

albuterol sulfate

Product NDC
53489-177
11-digit product format
534890177
Labeler code
53489
Product ID
53489-177_4d289f6d-634d-2125-e063-6394a90aa25d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
albuterol sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA072637
Marketing category
ANDA
Marketing start
1989-12-05
Substance
ALBUTEROL SULFATE
Active strength
4 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 sulfate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBUTEROL SULFATE4 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
53489-177-01albuterol sulfate100 in 1 BOTTLETABLET1007
53489-177-02albuterol sulfate50 in 1 BOTTLETABLET507
53489-177-03albuterol sulfate250 in 1 BOTTLETABLET2507
53489-177-05albuterol sulfate500 in 1 BOTTLETABLET5007
53489-177-10albuterol sulfate1000 in 1 BOTTLETABLET10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53489-177-01EA - Each53489-1770bfa29cc-07ff-485c-b258-ad198543a23012012-07-24
53489-177-05EA - Each53489-177f487bf21-fc81-43c4-a8c4-47ca4ed5293c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
albuterol sulfateACTIVE INGREDIENT021SEF3731ALBUTEROL SULFATE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]3
ALBUTEROL SULFATEACTIVE INGREDIENT021SEF3731ALBUTEROL SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.]3
ALBUTEROLACTIVE MOIETYQF8SVZ843EALBUTEROL SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.]3
albuterolACTIVE MOIETYQF8SVZ843EALBUTEROL SULFATE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]3
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKALBUTEROL SULFATE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKALBUTEROL SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.]3
magnesium stearateINACTIVE INGREDIENT70097M6I30ALBUTEROL SULFATE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALBUTEROL SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.]3
sodium starch glycolate type a potatoINACTIVE INGREDIENT5856J3G2A2ALBUTEROL SULFATE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ALBUTEROL SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALBUTEROL SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.]3
starch, cornINACTIVE INGREDIENTO8232NY3SJALBUTEROL SULFATE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]3
albuterol sulfateACTIVE INGREDIENT021SEF3731ALBUTEROL SULFATE TABLET [AMERICAN HEALTH PACKAGING]1
albuterolACTIVE MOIETYQF8SVZ843EALBUTEROL SULFATE TABLET [AMERICAN HEALTH PACKAGING]1
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKALBUTEROL SULFATE TABLET [AMERICAN HEALTH PACKAGING]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ALBUTEROL SULFATE TABLET [AMERICAN HEALTH PACKAGING]1
sodium starch glycolate type a potatoINACTIVE INGREDIENT5856J3G2A2ALBUTEROL SULFATE TABLET [AMERICAN HEALTH PACKAGING]1
starch, cornINACTIVE INGREDIENTO8232NY3SJALBUTEROL SULFATE TABLET [AMERICAN HEALTH PACKAGING]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53489-177ALBUTEROL SULFATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6Current NDC, Legacy NDC, 5 package rows20190207_87b8cd3c-2849-4b50-b63e-9ea379165c07.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197316albuterol 2 MG Oral TabletPSN87b8cd3c-2849-4b50-b63e-9ea379165c077
197318albuterol 4 MG Oral TabletPSN87b8cd3c-2849-4b50-b63e-9ea379165c077
197316albuterol 2 MG Oral TabletSCD87b8cd3c-2849-4b50-b63e-9ea379165c077
197318albuterol 4 MG Oral TabletSCD87b8cd3c-2849-4b50-b63e-9ea379165c077
197316albuterol 2 MG (as albuterol sulfate 2.4 MG) Oral TabletSY87b8cd3c-2849-4b50-b63e-9ea379165c077
197318albuterol 4 MG (as albuterol sulfate 4.8 MG) Oral TabletSY87b8cd3c-2849-4b50-b63e-9ea379165c077
197316albuterol 2 MG Oral TabletPSNb0f73459-baeb-42a7-be48-2c3647d9b2055
197318albuterol 4 MG Oral TabletPSNb0f73459-baeb-42a7-be48-2c3647d9b2055
197316albuterol 2 MG Oral TabletSCDb0f73459-baeb-42a7-be48-2c3647d9b2055
197318albuterol 4 MG Oral TabletSCDb0f73459-baeb-42a7-be48-2c3647d9b2055
197316albuterol 2 MG (as albuterol sulfate 2.4 MG) Oral TabletSYb0f73459-baeb-42a7-be48-2c3647d9b2055
197318albuterol 4 MG (as albuterol sulfate 4.8 MG) Oral TabletSYb0f73459-baeb-42a7-be48-2c3647d9b2055
197316albuterol 2 MG Oral TabletPSNa22af54a-c010-ab8b-e053-2a95a90a88624
197318albuterol 4 MG Oral TabletPSNa22af54a-c010-ab8b-e053-2a95a90a88624
197316albuterol 2 MG Oral TabletSCDa22af54a-c010-ab8b-e053-2a95a90a88624
197318albuterol 4 MG Oral TabletSCDa22af54a-c010-ab8b-e053-2a95a90a88624
197316albuterol 2 MG (as albuterol sulfate 2.4 MG) Oral TabletSYa22af54a-c010-ab8b-e053-2a95a90a88624
197318albuterol 4 MG (as albuterol sulfate 4.8 MG) Oral TabletSYa22af54a-c010-ab8b-e053-2a95a90a88624
197316albuterol 2 MG Oral TabletPSNb49edc01-1ea6-4f88-883a-bb4bc2bf4b3f3
197318albuterol 4 MG Oral TabletPSNb49edc01-1ea6-4f88-883a-bb4bc2bf4b3f3
197316albuterol 2 MG Oral TabletSCDb49edc01-1ea6-4f88-883a-bb4bc2bf4b3f3
197318albuterol 4 MG Oral TabletSCDb49edc01-1ea6-4f88-883a-bb4bc2bf4b3f3
197316albuterol 2 MG (as albuterol sulfate 2.4 MG) Oral TabletSYb49edc01-1ea6-4f88-883a-bb4bc2bf4b3f3
197318albuterol 4 MG (as albuterol sulfate 4.8 MG) Oral TabletSYb49edc01-1ea6-4f88-883a-bb4bc2bf4b3f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53489-177-0153489017701100 TABLET in 1 BOTTLE (53489-177-01) 100 tablet1989-12-050000-00-00NoNoCurrent
53489-177-025348901770250 TABLET in 1 BOTTLE (53489-177-02) 50 tablet1989-12-050000-00-00NoNoCurrent
53489-177-0353489017703250 TABLET in 1 BOTTLE (53489-177-03) 250 tablet1989-12-050000-00-00NoNoCurrent
53489-177-0553489017705500 TABLET in 1 BOTTLE (53489-177-05) 500 tablet1989-12-050000-00-00NoNoCurrent
53489-177-10534890177101000 TABLET in 1 BOTTLE (53489-177-10) 1000 tablet1989-12-050000-00-00NoNoCurrent