FDA.reportPublic FDA data

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE

Product NDC
76204-600
11-digit product format
762040600
Labeler code
76204
Product ID
76204-600_459ba094-3b2f-c16c-e063-6294a90aa828
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide and Albuterol Sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Ritedose Pharmaceuticals, LLC
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76204-600-01IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE1 in 1 POUCHSOLUTION123
76204-600-01IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE30 in 1 CARTONSOLUTION3023
76204-600-05IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE5 in 1 POUCHSOLUTION523
76204-600-05IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE6 in 1 CARTONSOLUTION623
76204-600-12IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE5 in 1 POUCHSOLUTION523
76204-600-12IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE12 in 1 CARTONSOLUTION1223
76204-600-30IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE30 in 1 POUCHSOLUTION3023
76204-600-30IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE1 in 1 CARTONSOLUTION123
76204-600-60IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE30 in 1 POUCHSOLUTION3023
76204-600-60IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE2 in 1 CARTONSOLUTION223

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76204-600-01ML - Milliliter76204-60019104a41-c42a-492a-a42d-2ce910e6fb7b12013-02-13
76204-600-05ML - Milliliter76204-6003bc4bee0-9ae0-4c68-8f0c-ba2b195eee8712013-03-03
76204-600-12ML - Milliliter76204-60079ef7f72-7a8a-472c-9f56-5fe999cfc6b012013-03-03
76204-600-30ML - Milliliter76204-600c089f794-1e88-4d38-a500-a6eb6b0e3de112015-10-02
76204-600-60ML - Milliliter76204-6000dc29075-c779-4f0e-a5b9-a6869b2992ad12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALBUTEROL SULFATEACTIVE INGREDIENT021SEF3731IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]7
IPRATROPIUM BROMIDEACTIVE INGREDIENTJ697UZ2A9JIPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]7
ALBUTEROLACTIVE MOIETYQF8SVZ843EIPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]7
IPRATROPIUMACTIVE MOIETYGR88G0I6ULIPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76204-600IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]21Current NDC, Legacy NDC, 10 package rows20241219_e0dee492-8bf9-4360-be9b-9d6ee1ecb256.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 SolutionPSNe0dee492-8bf9-4360-be9b-9d6ee1ecb25623
1437702albuterol 0.833 MG/ML / ipratropium bromide 0.167 MG/ML Inhalation SolutionSCDe0dee492-8bf9-4360-be9b-9d6ee1ecb25623
1437702albuterol 2.5 MG (as albuterol sulfate 3 MG) / ipratropium bromide 0.5 MG per 3 ML Inhalation SolutionSYe0dee492-8bf9-4360-be9b-9d6ee1ecb25623
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
76204-600-017620406000130 POUCH in 1 CARTON (76204-600-01) / 1 AMPULE in 1 POUCH / 3 mL in 1 AMPULE30 pouch2012-10-150000-00-00NoNoCurrent
76204-600-05762040600056 POUCH in 1 CARTON (76204-600-05) / 5 AMPULE in 1 POUCH / 3 mL in 1 AMPULE6 pouch2012-10-150000-00-00NoNoCurrent
76204-600-127620406001212 POUCH in 1 CARTON (76204-600-12) / 5 AMPULE in 1 POUCH / 3 mL in 1 AMPULE12 pouch2012-10-150000-00-00NoNoCurrent
76204-600-30762040600301 POUCH in 1 CARTON (76204-600-30) / 30 AMPULE in 1 POUCH / 3 mL in 1 AMPULE1 pouch2012-10-150000-00-00NoNoCurrent
76204-600-60762040600602 POUCH in 1 CARTON (76204-600-60) / 30 AMPULE in 1 POUCH / 3 mL in 1 AMPULE2 pouch2012-10-150000-00-00NoNoCurrent