FDA.reportPublic FDA data

Ipratropium Bromide and Albuterol Sulfate

Product NDC
64980-645
11-digit product format
649800645
Labeler code
64980
Product ID
64980-645_3246ea9c-eac0-4088-e063-6294a90a8cf8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide and Albuterol Sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA076749
Marketing category
ANDA
Marketing start
2025-03-14
Substance
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
Active strength
3; .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 SULFATE3 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
64980-645-03Ipratropium Bromide and Albuterol Sulfate5 in 1 POUCHSOLUTION51
64980-645-03Ipratropium Bromide and Albuterol Sulfate30 in 1 CARTONSOLUTION301
64980-645-06Ipratropium Bromide and Albuterol Sulfate5 in 1 POUCHSOLUTION51
64980-645-06Ipratropium Bromide and Albuterol Sulfate60 in 1 CARTONSOLUTION601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-645-03ML - Milliliter64980-645f28668e7-ca09-4810-a1ec-e54ed9a1431c12025-06-13
64980-645-06ML - Milliliter64980-645ed5303b0-d95e-4566-ba71-29a74fb015d612025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-645IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [RISING PHARMA HOLDINGS, INC.]1Current NDC, 4 package rows20250411_3246dfab-61d7-27ba-e063-6294a90ac180.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 SolutionPSN3246dfab-61d7-27ba-e063-6294a90ac1801
1437702albuterol 0.833 MG/ML / ipratropium bromide 0.167 MG/ML Inhalation SolutionSCD3246dfab-61d7-27ba-e063-6294a90ac1801
1437702albuterol 2.5 MG (as albuterol sulfate 3 MG) / ipratropium bromide 0.5 MG per 3 ML Inhalation SolutionSY3246dfab-61d7-27ba-e063-6294a90ac1801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64980-645-036498006450330 POUCH in 1 CARTON (64980-645-03) / 5 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE30 pouch2025-03-14NoNoCurrent
64980-645-066498006450660 POUCH in 1 CARTON (64980-645-06) / 5 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE60 pouch2025-03-14NoNoCurrent