ALBUTEROL SULFATE

Product NDC
72162-2064
11-digit product format
721622064
Labeler code
72162
Product ID
72162-2064_04fd53e4-2877-4738-b62b-527b3770ba4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALBUTEROL SULFATE
Dosage form
SYRUP
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212197
Marketing category
ANDA
Marketing start
2019-09-06
Substance
ALBUTEROL SULFATE
Active strength
2 mg/5mL
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 SULFATE2 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii021SEF3731
Rxcui755497

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
36390b75-5438-47d3-af60-732a654e9025Product name220220110
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
387afa72-0c5a-0d6b-ee2c-60c3506659e8Product name620210518
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
1b8ea3ec-88bd-98ea-c961-00ae340b5b14Product name220200220
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
3aa5a017-61e9-0c89-adef-13e7964d22f0Product name320171208
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
c3c27a99-b8bc-4955-841c-26555f58ee7eProduct name120150421
bc98cf6f-a973-7162-5e30-0e7dd8c56bc3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2064-2ALBUTEROL SULFATE473 mL in 1 BOTTLESYRUP473101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2064-2ML - Milliliter72162-2064ac7027fd-34b7-4dea-8052-d176c9811d5812023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2064ALBUTEROL SULFATE SYRUP [BRYANT RANCH PREPACK]101Current NDC, 1 package rows20240816_45e07bdd-78f9-4055-9de3-646e67de7eaf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
755497albuterol sulfate 2 MG in 5 mL Oral SolutionPSN45e07bdd-78f9-4055-9de3-646e67de7eaf101
755497albuterol 0.4 MG/ML Oral SolutionSCD45e07bdd-78f9-4055-9de3-646e67de7eaf101
755497albuterol (as albuterol sulfate) 2 MG per 5 ML SyrupSY45e07bdd-78f9-4055-9de3-646e67de7eaf101
755497albuterol 2 MG per 5 ML SyrupSY45e07bdd-78f9-4055-9de3-646e67de7eaf101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2064-272162206402473 mL in 1 BOTTLE (72162-2064-2) 473 ml2023-08-15NoNoHistorical