FDA.reportPublic FDA data

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE

Product NDC
50090-1382
11-digit product format
500901382
Labeler code
50090
Product ID
50090-1382_d50406d8-cb32-45b6-be89-08fdab21fea9
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
Substance
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
Active strength
2.5; .5 mg/3mL; mg/3mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBUTEROL SULFATE2.5 mg/3mL
IPRATROPIUM BROMIDE.5 mg/3mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii021SEF3731, J697UZ2A9J
Rxcui1437702

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9ccc399f-9de9-4e86-a0ca-d7a2e7c6c36cProduct name220251106
d953267a-4ca0-4d44-91ad-712cdee8ab38Product name220250630
26005090-31a1-441d-920b-db3101a55d53Product name320250221
1c39b897-7219-42a1-9f3a-ec86cfd7b04bProduct name320250218
0a278166-c8aa-41b6-b4a5-6ac332bde76aProduct name120230718
c76bcd0f-25eb-471e-b970-1956c95c26c5Product name120230425
36390b75-5438-47d3-af60-732a654e9025Product name220220110
387afa72-0c5a-0d6b-ee2c-60c3506659e8Product name620210518
1b8ea3ec-88bd-98ea-c961-00ae340b5b14Product name220200220
3aa5a017-61e9-0c89-adef-13e7964d22f0Product name320171208
6ac73021-459f-435b-b6c5-8c7d6a50c021Product name220170404
c3c27a99-b8bc-4955-841c-26555f58ee7eProduct name120150421
bc98cf6f-a973-7162-5e30-0e7dd8c56bc3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1382-02023-02-07C16284748780-1f386c649-f8c6-0266-e053-dadaa90a7c1aIpratropium Bromide and Albuterol Sulfate Inhalation Solution 0.5 mg / 3 mg per 3 mL (RDP)
50090-1382-02023-01-30C16284748780-1f386c649-f8c6-0266-e053-dadaa90a7c1aIpratropium Bromide and Albuterol Sulfate Inhalation Solution 0.5 mg / 3 mg per 3 mL (RDP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1382-0IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE3 mL in 1 VIALSOLUTION318
50090-1382-0IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE30 in 1 CARTONSOLUTION3018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1382-0ML - Milliliter50090-138299af8832-e85f-4b08-a889-7cb38083d22c12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1382IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [A-S MEDICATION SOLUTIONS]18Current NDC, Legacy NDC, 2 package rows20240612_e452afc2-dc33-4be7-949e-143b2e5f530c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1437702ipratropium Br 0.5 MG / albuterol sulfate 3 MG in 3 ML Inhalation SolutionPSNe452afc2-dc33-4be7-949e-143b2e5f530c18
1437702albuterol 0.833 MG/ML / ipratropium bromide 0.167 MG/ML Inhalation SolutionSCDe452afc2-dc33-4be7-949e-143b2e5f530c18
1437702albuterol 2.5 MG (as albuterol sulfate 3 MG) / ipratropium bromide 0.5 MG per 3 ML Inhalation SolutionSYe452afc2-dc33-4be7-949e-143b2e5f530c18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1382-05009013820030 VIAL in 1 CARTON (50090-1382-0) / 3 mL in 1 VIAL30 vial2014-11-280000-00-00NoNoCurrent