IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE

Product NDC
50090-4103
11-digit product format
500904103
Labeler code
50090
Product ID
50090-4103_e9ff0e4d-3e59-4a09-958c-5e95f7165a32
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide and Albuterol Sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
A-S Medication Solutions
Application
ANDA202496
Marketing category
ANDA
Marketing start
2012-10-15
Marketing end
0000-00-00
Substance
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
Active strength
3 mg/3mL; mg/3mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA]
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
50090-4103-02023-02-07C16284748780-1f386c64a-1b8e-0266-e053-dadaa90a7c1a01998e2b-b2c7-4606-9a2d-b8bd83b455fc
50090-4103-02023-01-30C16284748780-1f386c64a-1b8e-0266-e053-dadaa90a7c1a01998e2b-b2c7-4606-9a2d-b8bd83b455fc

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4103-0ML - Milliliter50090-410365d4b98b-3542-4fe3-9aa9-040e7479a37c12022-01-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4103-0500904103001 POUCH in 1 CARTON (50090-4103-0) > 30 mL in 1 POUCH1 pouch2019-01-290000-00-00NoNoCurrent