FDA.reportPublic FDA data

ALBUTEROL SULFATE

Product NDC
68999-189
11-digit product format
689990189
Labeler code
68999
Product ID
68999-189_462ca25f-d461-c069-e063-6394a90a528a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
SYRUP
Route
ORAL
Labeler
Chartwell Governmental & Specialty RX, LLC.
Application
ANDA077788
Marketing category
ANDA
Marketing start
2007-06-26
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
68999-189-05ALBUTEROL SULFATE5 mL in 1 CUPSYRUP51
68999-189-20ALBUTEROL SULFATE20 mL in 1 CUPSYRUP201
68999-189-23ALBUTEROL SULFATE10 in 1 TRAYSYRUP101
68999-189-23ALBUTEROL SULFATE2 in 1 BOXSYRUP21
68999-189-24ALBUTEROL SULFATE2 in 1 BOXSYRUP21
68999-189-24ALBUTEROL SULFATE10 in 1 TRAYSYRUP101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
755497albuterol sulfate 2 MG in 5 mL Oral SolutionPSNdd47559a-84f6-42a5-a00e-48754505418e1
755497albuterol 0.4 MG/ML Oral SolutionSCDdd47559a-84f6-42a5-a00e-48754505418e1
755497albuterol (as albuterol sulfate) 2 MG per 5 ML SyrupSYdd47559a-84f6-42a5-a00e-48754505418e1
755497albuterol 2 MG per 5 ML SyrupSYdd47559a-84f6-42a5-a00e-48754505418e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68999-189-05689990189055 mL in 1 CUP5 mlHistorical
68999-189-206899901892020 mL in 1 CUP20 mlHistorical
68999-189-23689990189232 TRAY in 1 BOX (68999-189-23) / 10 CUP in 1 TRAY / 20 mL in 1 CUP (68999-189-20) 2 tray2025-12-15NoNoCurrent
68999-189-24689990189242 TRAY in 1 BOX (68999-189-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-189-05) 2 tray2025-12-15NoNoCurrent