Albuterol Sulfate

Product NDC
62135-672
11-digit product format
621350672
Labeler code
62135
Product ID
62135-672_fe7cbf82-9f32-327e-e053-6294a90aebc8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA072151
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Albuterol Sulfate
Listing expiration
2026-12-31

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
62135-672-90Albuterol Sulfate90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-672ALBUTEROL SULFATE TABLET [CHARTWELL RX, LLC]1Current NDC, 1 package rows20230620_81cdae6f-99d7-468b-9ab8-fecb1d42298d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197316albuterol 2 MG Oral TabletPSN81cdae6f-99d7-468b-9ab8-fecb1d42298d1
197318albuterol 4 MG Oral TabletPSN81cdae6f-99d7-468b-9ab8-fecb1d42298d1
197316albuterol 2 MG Oral TabletSCD81cdae6f-99d7-468b-9ab8-fecb1d42298d1
197318albuterol 4 MG Oral TabletSCD81cdae6f-99d7-468b-9ab8-fecb1d42298d1
197316albuterol 2 MG (as albuterol sulfate 2.4 MG) Oral TabletSY81cdae6f-99d7-468b-9ab8-fecb1d42298d1
197318albuterol 4 MG (as albuterol sulfate 4.8 MG) Oral TabletSY81cdae6f-99d7-468b-9ab8-fecb1d42298d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-672-906213506729090 TABLET in 1 BOTTLE (62135-672-90) 90 tablet2023-06-14NoNoCurrent