FDA.reportPublic FDA data

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE

Product NDC
60429-975
11-digit product format
604290975
Labeler code
60429
Product ID
60429-975_49785738-8176-1016-e063-6294a90a1cce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide and Albuterol Sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Golden State Medical Supply, Inc.
Application
ANDA202496
Marketing category
ANDA
Marketing start
2012-10-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60429-975-30IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE30 in 1 POUCHSOLUTION3017
60429-975-30IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE1 in 1 CARTONSOLUTION117
60429-975-60IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE30 in 1 POUCHSOLUTION3017
60429-975-60IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE2 in 1 CARTONSOLUTION217

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-975-30ML - Milliliter60429-975ca097e74-020a-46fd-9fc2-c36f7183993d12017-11-06
60429-975-60ML - Milliliter60429-9754d4e67a7-a6f1-44e0-a3cc-5756ec66f32212017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-975IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [GOLDEN STATE MEDICAL SUPPLY, INC.]15Current NDC, Legacy NDC, 4 package rows20250117_2ebc820b-a423-46ef-8eba-9fbc93daff44.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 SolutionPSN2ebc820b-a423-46ef-8eba-9fbc93daff4417
1437702albuterol 0.833 MG/ML / ipratropium bromide 0.167 MG/ML Inhalation SolutionSCD2ebc820b-a423-46ef-8eba-9fbc93daff4417
1437702albuterol 2.5 MG (as albuterol sulfate 3 MG) / ipratropium bromide 0.5 MG per 3 ML Inhalation SolutionSY2ebc820b-a423-46ef-8eba-9fbc93daff4417

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60429-975-30604290975301 POUCH in 1 CARTON (60429-975-30) / 30 AMPULE in 1 POUCH / 3 mL in 1 AMPULE1 pouch2017-10-170000-00-00NoNoCurrent
60429-975-60604290975602 POUCH in 1 CARTON (60429-975-60) / 30 AMPULE in 1 POUCH / 3 mL in 1 AMPULE2 pouch2017-10-170000-00-00NoNoCurrent