IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE

Product NDC
60687-405
11-digit product format
606870405
Labeler code
60687
Product ID
60687-405_1a02568a-4fa8-5ec8-e063-6294a90a1558
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide and Albuterol Sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
American Health Packaging
Application
ANDA202496
Marketing category
ANDA
Marketing start
2019-01-21
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-405-79IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE1 in 1 POUCHSOLUTION14
60687-405-79IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE3 mL in 1 AMPULESOLUTION34
60687-405-83IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE30 in 1 CARTONSOLUTION304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-405-79ML - Milliliter60687-40570ddf024-5fb5-4bd0-8ddd-7968f5882d5f12019-01-24
60687-405-83ML - Milliliter60687-4050fd65df3-edf4-4bb7-b9cd-eac11181552f12019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-405IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [AMERICAN HEALTH PACKAGING]4Current NDC, Legacy NDC, 3 package rows20240605_c04c6ec8-1401-424d-8126-63080e36c4b9.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 SolutionPSNc04c6ec8-1401-424d-8126-63080e36c4b94
1437702albuterol 0.833 MG/ML / ipratropium bromide 0.167 MG/ML Inhalation SolutionSCDc04c6ec8-1401-424d-8126-63080e36c4b94
1437702albuterol 2.5 MG (as albuterol sulfate 3 MG) / ipratropium bromide 0.5 MG per 3 ML Inhalation SolutionSYc04c6ec8-1401-424d-8126-63080e36c4b94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-405-79606870405791 in 1 POUCHHistorical
60687-405-836068704058330 POUCH in 1 CARTON (60687-405-83) / 1 AMPULE in 1 POUCH (60687-405-79) / 3 mL in 1 AMPULE30 pouch2019-01-210000-00-00NoNoCurrent