Albuterol

Product NDC
75834-273
11-digit product format
758340273
Labeler code
75834
Product ID
75834-273_5b89a3bb-e3bb-421d-89f7-f180e01a1b4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
albuterol sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Nivagen Pharmaceuticals Inc
Application
ANDA210948
Marketing category
ANDA
Marketing start
2021-01-21
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75834-273-012022-02-16C16284748780-1d6a99b39-4c0a-a426-e053-dadaa90af4c2albuterol-tablets
75834-273-012022-01-28C16284748780-1d6a99b39-4c0a-a426-e053-dadaa90af4c2albuterol-tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75834-273-01Albuterol100 in 1 BOTTLE, PLASTICTABLET1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-273-01EA - Each75834-273fbad84bf-dcda-48a1-b7bf-dcf985bbb9c712021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-273ALBUTEROL (ALBUTEROL SULFATE) TABLET [NIVAGEN PHARMACEUTICALS INC]4Current NDC, Legacy NDC, 1 package rows20220217_b735e92d-eb1a-6fc1-e053-2995a90afce2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197316albuterol 2 MG Oral TabletPSNb735e92d-eb1a-6fc1-e053-2995a90afce24
197318albuterol 4 MG Oral TabletPSNb735e92d-eb1a-6fc1-e053-2995a90afce24
197316albuterol 2 MG Oral TabletSCDb735e92d-eb1a-6fc1-e053-2995a90afce24
197318albuterol 4 MG Oral TabletSCDb735e92d-eb1a-6fc1-e053-2995a90afce24
197316albuterol 2 MG (as albuterol sulfate 2.4 MG) Oral TabletSYb735e92d-eb1a-6fc1-e053-2995a90afce24
197318albuterol 4 MG (as albuterol sulfate 4.8 MG) Oral TabletSYb735e92d-eb1a-6fc1-e053-2995a90afce24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75834-273-0175834027301100 TABLET in 1 BOTTLE, PLASTIC (75834-273-01) 100 tablet2021-01-210000-00-00NoNoCurrent