ipratropium bromide and albuterol sulfate

Product NDC
68788-9279
11-digit product format
687889279
Labeler code
68788
Product ID
68788-9279_f409eac5-0d22-40f2-b79e-6b558499e8a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ipratropium bromide and albuterol sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA202496
Marketing category
ANDA
Marketing start
2015-03-02
Marketing end
0000-00-00
Substance
IPRATROPIUM BROMIDE; ALBUTEROL SULFATE
Active strength
1 mg/3mL; mg/3mL
Pharmacologic classes
Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68788-9279-32022-02-23C16284748780-1d6a99b39-8ec3-a426-e053-dadaa90af4c28a1cb095-c3c6-4629-9a88-aeae949541ef
68788-9279-32022-01-28C16284748780-1d6a99b39-8ec3-a426-e053-dadaa90af4c28a1cb095-c3c6-4629-9a88-aeae949541ef

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-9279-3687889279036 POUCH in 1 CARTON (68788-9279-3) > 5 VIAL in 1 POUCH > 3 mL in 1 VIAL6 pouch2015-03-020000-00-00NoNoCurrent