Albuterol Sulfate

Product NDC
70518-2613
11-digit product format
705182613
Labeler code
70518
Product ID
70518-2613_caf0d15c-f108-05bf-e053-2995a90a4781
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
REMEDYREPACK INC.
Application
ANDA074880
Marketing category
ANDA
Marketing start
2020-03-05
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2613-02023-03-13C16284748780-1f386c649-aa0e-0266-e053-dadaa90a7c1ad8dd6385-9c62-4f8a-9876-2acd27a5bc80
70518-2613-02023-01-30C16284748780-1f386c649-aa0e-0266-e053-dadaa90a7c1ad8dd6385-9c62-4f8a-9876-2acd27a5bc80

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2613-0705182613001 POUCH in 1 CARTON (70518-2613-0) > 25 VIAL, SINGLE-DOSE in 1 POUCH > 3 mL in 1 VIAL, SINGLE-DOSE1 pouch2020-03-050000-00-00NoNoCurrent