FDA.reportPublic FDA data

Ipratropium Bromide and Albuterol Sulfate

Product NDC
0378-9671
11-digit product format
003789671
Labeler code
0378
Product ID
0378-9671_96603d2c-6783-4f6c-8b3e-de3eaabcc6aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide and Albuterol Sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA202496
Marketing category
ANDA
Marketing start
2013-03-01
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
0378-9671-30Ipratropium Bromide and Albuterol Sulfate1 in 1 CARTONSOLUTION17
0378-9671-31Ipratropium Bromide and Albuterol Sulfate3 mL in 1 AMPULESOLUTION37
0378-9671-31Ipratropium Bromide and Albuterol Sulfate1 in 1 POUCHSOLUTION17
0378-9671-60Ipratropium Bromide and Albuterol Sulfate30 in 1 POUCHSOLUTION307
0378-9671-60Ipratropium Bromide and Albuterol Sulfate2 in 1 CARTONSOLUTION27
0378-9671-64Ipratropium Bromide and Albuterol Sulfate30 in 1 POUCHSOLUTION307
0378-9671-64Ipratropium Bromide and Albuterol Sulfate3 mL in 1 AMPULESOLUTION37
0378-9671-93Ipratropium Bromide and Albuterol Sulfate30 in 1 CARTONSOLUTION307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-9671-30ML - Milliliter0378-9671fecf8d7a-ca63-4086-a192-cfe09593da7f12016-03-04
0378-9671-31ML - Milliliter0378-9671441e8202-3014-467f-839f-1cb56dd1ff5a12015-05-05
0378-9671-58ML - Milliliter0378-9671e0ed7cbb-725f-41b4-98a8-8e4fbac96aa512013-10-17
0378-9671-60ML - Milliliter0378-9671ac7fec3f-8285-492f-b246-26b74402bbb712016-04-04
0378-9671-91ML - Milliliter0378-967132a69a83-77f5-460b-ac59-cdb79109616712014-04-03
0378-9671-93ML - Milliliter0378-9671f9a81245-211d-421f-9a2b-9b034708627c12013-07-02
0378-9671-98ML - Milliliter0378-9671d5fa01b8-04ef-4d82-bc9d-1bc4f51852f712015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Albuterol SulfateACTIVE INGREDIENT021SEF3731IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [MYLAN PHARMACEUTICALS, INC.]1
Ipratropium BromideACTIVE INGREDIENTJ697UZ2A9JIPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [MYLAN PHARMACEUTICALS, INC.]1
AlbuterolACTIVE MOIETYQF8SVZ843EIPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [MYLAN PHARMACEUTICALS, INC.]1
IpratropiumACTIVE MOIETYGR88G0I6ULIPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [MYLAN PHARMACEUTICALS, INC.]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBIPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [MYLAN PHARMACEUTICALS, INC.]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XIPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [MYLAN PHARMACEUTICALS, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RIPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [MYLAN PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-9671IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [MYLAN PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 8 package rows20190514_23c05e9a-9df5-4978-8831-cf562aa4ba92.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 SolutionPSN23c05e9a-9df5-4978-8831-cf562aa4ba927
1437702albuterol 0.833 MG/ML / ipratropium bromide 0.167 MG/ML Inhalation SolutionSCD23c05e9a-9df5-4978-8831-cf562aa4ba927
1437702albuterol 2.5 MG (as albuterol sulfate 3 MG) / ipratropium bromide 0.5 MG per 3 ML Inhalation SolutionSY23c05e9a-9df5-4978-8831-cf562aa4ba927

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-9671-30003789671301 POUCH in 1 CARTON (0378-9671-30) / 30 AMPULE in 1 POUCH (0378-9671-64) / 3 mL in 1 AMPULE1 pouch2013-03-010000-00-00NoNoCurrent
0378-9671-31003789671313 mL in 1 AMPULE3 mlHistorical
0378-9671-60003789671602 POUCH in 1 CARTON (0378-9671-60) / 30 AMPULE in 1 POUCH / 3 mL in 1 AMPULE2 pouch2013-03-010000-00-00NoNoCurrent
0378-9671-640037896716430 in 1 POUCHHistorical
0378-9671-930037896719330 POUCH in 1 CARTON (0378-9671-93) / 1 AMPULE in 1 POUCH (0378-9671-31) / 3 mL in 1 AMPULE30 pouch2013-03-010000-00-00NoNoCurrent