Albuterol Sulfate

Product NDC
70518-3442
11-digit product format
705183442
Labeler code
70518
Product ID
70518-3442_e531328f-9ffc-08ed-e053-2995a90a5693
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
REMEDYREPACK INC.
Application
ANDA077839
Marketing category
ANDA
Marketing start
2022-06-23
Marketing end
0000-00-00
Substance
ALBUTEROL SULFATE
Active strength
3 mg/3mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3442-02024-03-20C16284748780-11030e365-04fa-111a-e063-dadaa90a10e2aa3a49f3-667a-4897-a1b7-f067d025a93c
70518-3442-02024-01-30C16284748780-11030e365-04fa-111a-e063-dadaa90a10e2aa3a49f3-667a-4897-a1b7-f067d025a93c

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3442ALBUTEROL SULFATE SOLUTION [REMEDYREPACK INC.]3Legacy NDC20240709_aa3a49f3-667a-4897-a1b7-f067d025a93c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3442-0705183442001 POUCH in 1 CARTON (70518-3442-0) > 25 AMPULE in 1 POUCH > 3 mL in 1 AMPULE1 pouch2022-06-230000-00-00NoNoCurrent