FDA.reportPublic FDA data

Ipratropium Bromide and Albuterol Sulfate

Product NDC
69097-840
11-digit product format
690970840
Labeler code
69097
Product ID
69097-840_14b7dfcc-b3a8-4027-9544-8d52ec2aacf3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide and Albuterol Sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Cipla USA Inc.
Application
ANDA202496
Marketing category
ANDA
Marketing start
2020-06-01
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
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
69097-840-34Ipratropium Bromide and Albuterol Sulfate1 in 1 POUCHSOLUTION14
69097-840-34Ipratropium Bromide and Albuterol Sulfate3 mL in 1 VIALSOLUTION34
69097-840-53Ipratropium Bromide and Albuterol Sulfate30 in 1 CARTONSOLUTION304
69097-840-64Ipratropium Bromide and Albuterol Sulfate2 in 1 CARTONSOLUTION24
69097-840-64Ipratropium Bromide and Albuterol Sulfate30 in 1 POUCHSOLUTION304
69097-840-87Ipratropium Bromide and Albuterol Sulfate30 in 1 POUCHSOLUTION304
69097-840-87Ipratropium Bromide and Albuterol Sulfate1 in 1 CARTONSOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-840-34ML - Milliliter69097-8405a16cc51-9187-46af-8bb8-bc443a86e1f712020-07-13
69097-840-53ML - Milliliter69097-840b8d75775-7ce3-4c7b-b757-618388fd80a312020-07-13
69097-840-64ML - Milliliter69097-84055e72ceb-891c-4247-a259-e46aa955c45a12021-05-05
69097-840-87ML - Milliliter69097-840b274ad8b-5235-4d08-8633-24b17f4884ac12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-840IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [CIPLA USA INC.]4Current NDC, Legacy NDC, 7 package rows20240112_89d59bd9-c826-413c-8ed9-a1521a0c7cc5.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 SolutionPSN89d59bd9-c826-413c-8ed9-a1521a0c7cc54
1437702albuterol 0.833 MG/ML / ipratropium bromide 0.167 MG/ML Inhalation SolutionSCD89d59bd9-c826-413c-8ed9-a1521a0c7cc54
1437702albuterol 2.5 MG (as albuterol sulfate 3 MG) / ipratropium bromide 0.5 MG per 3 ML Inhalation SolutionSY89d59bd9-c826-413c-8ed9-a1521a0c7cc54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-840-34690970840341 in 1 POUCHHistorical
69097-840-536909708405330 POUCH in 1 CARTON (69097-840-53) / 1 VIAL in 1 POUCH (69097-840-34) / 3 mL in 1 VIAL30 pouch2020-06-010000-00-00NoNoCurrent
69097-840-64690970840642 POUCH in 1 CARTON (69097-840-64) / 30 VIAL in 1 POUCH / 3 mL in 1 VIAL2 pouch2020-06-010000-00-00NoNoCurrent
69097-840-87690970840871 POUCH in 1 CARTON (69097-840-87) / 30 VIAL in 1 POUCH / 3 mL in 1 VIAL1 pouch2020-06-010000-00-00NoNoCurrent