ALBUTEROL SULFATE

Product NDC
68788-7573
11-digit product format
687887573
Labeler code
68788
Product ID
68788-7573_e9b207d7-0c31-45ac-a0ab-8d5b96ffd983
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALBUTEROL SULFATE
Dosage form
SYRUP
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA212197
Marketing category
ANDA
Marketing start
2020-05-01
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
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
68788-7573-4ALBUTEROL SULFATE473 mL in 1 BOTTLESYRUP4736

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7573ALBUTEROL SULFATE SYRUP [PREFERRED PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 1 package rows20250105_4aafc2dd-744d-4726-828f-70355aee6f70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
755497albuterol sulfate 2 MG in 5 mL Oral SolutionPSN4aafc2dd-744d-4726-828f-70355aee6f706
755497albuterol 0.4 MG/ML Oral SolutionSCD4aafc2dd-744d-4726-828f-70355aee6f706
755497albuterol (as albuterol sulfate) 2 MG per 5 ML SyrupSY4aafc2dd-744d-4726-828f-70355aee6f706
755497albuterol 2 MG per 5 ML SyrupSY4aafc2dd-744d-4726-828f-70355aee6f706

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7573-468788757304473 mL in 1 BOTTLE (68788-7573-4) 473 ml2020-05-010000-00-00NoNoCurrent