FDA.reportPublic FDA data

ALBUTEROL SULFATE

Product NDC
62135-189
11-digit product format
621350189
Labeler code
62135
Product ID
62135-189_316befe4-1351-2acb-e063-6394a90a9a17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
SYRUP
Route
ORAL
Labeler
Chartwell 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
62135-189-05ALBUTEROL SULFATE5 mL in 1 CUPSYRUP54
62135-189-20ALBUTEROL SULFATE20 mL in 1 CUPSYRUP204
62135-189-23ALBUTEROL SULFATE10 in 1 TRAYSYRUP104
62135-189-23ALBUTEROL SULFATE2 in 1 BOXSYRUP24
62135-189-24ALBUTEROL SULFATE10 in 1 TRAYSYRUP104
62135-189-24ALBUTEROL SULFATE2 in 1 BOXSYRUP24
62135-189-41ALBUTEROL SULFATE120 mL in 1 CONTAINERSYRUP1204
62135-189-47ALBUTEROL SULFATE473 mL in 1 CONTAINERSYRUP4734

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-189-05ML - Milliliter62135-1894729b4ed-c771-4576-a4f1-bc21aa6540b412025-05-14
62135-189-20ML - Milliliter62135-189093c1296-0ad9-40e2-92e5-d63360244dff12025-05-14
62135-189-23ML - Milliliter62135-18938b03ed0-fabc-4682-8058-db8c66024ba812025-05-14
62135-189-24ML - Milliliter62135-18977e5baf7-336a-4c95-9ae1-e9e834727bbb12025-05-14
62135-189-41ML - Milliliter62135-1895f784daa-6d63-4d59-aae3-e2ecda12d19112022-07-06
62135-189-47ML - Milliliter62135-1893816c34d-2aa0-4228-a407-fab0294b7c6912022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-189ALBUTEROL SULFATE SYRUP [CHARTWELL RX, LLC]4Current NDC, Legacy NDC, 8 package rows20250331_560df50c-e2c4-459f-9d89-bf7e6588949e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
755497albuterol sulfate 2 MG in 5 mL Oral SolutionPSN560df50c-e2c4-459f-9d89-bf7e6588949e4
755497albuterol 0.4 MG/ML Oral SolutionSCD560df50c-e2c4-459f-9d89-bf7e6588949e4
755497albuterol (as albuterol sulfate) 2 MG per 5 ML SyrupSY560df50c-e2c4-459f-9d89-bf7e6588949e4
755497albuterol 2 MG per 5 ML SyrupSY560df50c-e2c4-459f-9d89-bf7e6588949e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-189-05621350189055 mL in 1 CUP5 mlHistorical
62135-189-206213501892020 mL in 1 CUP20 mlHistorical
62135-189-23621350189232 TRAY in 1 BOX (62135-189-23) / 10 CUP in 1 TRAY / 20 mL in 1 CUP (62135-189-20) 2 tray2025-03-26NoNoHistorical
62135-189-24621350189242 TRAY in 1 BOX (62135-189-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-189-05) 2 tray2025-03-26NoNoHistorical
62135-189-4162135018941120 mL in 1 CONTAINER (62135-189-41) 120 ml2022-06-080000-00-00NoNoCurrent
62135-189-4762135018947473 mL in 1 CONTAINER (62135-189-47) 473 ml2022-06-080000-00-00NoNoCurrent