Albuterol Sulfate

Product NDC
68258-8001
11-digit product format
682588001
Labeler code
68258
Product ID
68258-8001_fa09c411-6ac1-4d89-8eaa-7e8810bba033
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
SYRUP
Route
OCCLUSIVE DRESSING TECHNIQUE
Labeler
Dispensing Solutions, Inc.
Application
ANDA074749
Marketing category
ANDA
Marketing start
1998-01-30
Marketing end
0000-00-00
Substance
ALBUTEROL SULFATE
Active strength
2 mg/5mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
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
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
c3c27a99-b8bc-4955-841c-26555f58ee7eProduct name120150421
bc98cf6f-a973-7162-5e30-0e7dd8c56bc3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68258-8001-12019-11-13C16284748780-197449f38-b6de-f6ea-e053-dbdaa90aa703Albuterol Sulfate Syrup

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68258-8001-1Albuterol Sulfate473 mL in 1 BOTTLESYRUP4732

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68258-8001ALBUTEROL SULFATE SYRUP [DISPENSING SOLUTIONS, INC.]2Legacy NDC, 1 package rows20111004_26138eb9-ff04-41cc-94c8-83edcba78b86.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
68258-8001-168258800101473 mL in 1 BOTTLE473 mlHistorical