FDA.reportPublic FDA data

Ipratropium Bromide and Albuterol Sulfate

Product NDC
0487-0201
11-digit product format
004870201
Labeler code
0487
Product ID
0487-0201_32473735-b131-709c-e063-6294a90afde8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide and Albuterol Sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Nephron Pharmaceuticals Corporation
Application
ANDA076749
Marketing category
ANDA
Marketing start
2007-12-31
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0a278166-c8aa-41b6-b4a5-6ac332bde76aProduct name120230718
c76bcd0f-25eb-471e-b970-1956c95c26c5Product name120230425
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
36390b75-5438-47d3-af60-732a654e9025Product name220220110
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
387afa72-0c5a-0d6b-ee2c-60c3506659e8Product name620210518
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
1b8ea3ec-88bd-98ea-c961-00ae340b5b14Product name220200220
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
3aa5a017-61e9-0c89-adef-13e7964d22f0Product name320171208
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
6ac73021-459f-435b-b6c5-8c7d6a50c021Product name220170404
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c3c27a99-b8bc-4955-841c-26555f58ee7eProduct name120150421
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
bc98cf6f-a973-7162-5e30-0e7dd8c56bc3Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0487-0201-01Ipratropium Bromide and Albuterol Sulfate30 in 1 CARTONSOLUTION3014
0487-0201-01Ipratropium Bromide and Albuterol Sulfate1 in 1 POUCHSOLUTION114
0487-0201-02Ipratropium Bromide and Albuterol Sulfate1 in 1 POUCHSOLUTION114
0487-0201-02Ipratropium Bromide and Albuterol Sulfate30 in 1 CARTONSOLUTION3014
0487-0201-03Ipratropium Bromide and Albuterol Sulfate6 in 1 CARTONSOLUTION614
0487-0201-03Ipratropium Bromide and Albuterol Sulfate5 in 1 POUCHSOLUTION514
0487-0201-60Ipratropium Bromide and Albuterol Sulfate12 in 1 CARTONSOLUTION1214
0487-0201-60Ipratropium Bromide and Albuterol Sulfate5 in 1 POUCHSOLUTION514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0487-0201-01ML - Milliliter0487-0201636a5388-7d5d-47fa-a169-4ce71bcadfdc12012-07-24
0487-0201-02ML - Milliliter0487-0201e95db3a7-d3f4-4157-bcdf-0cabbb19a48412012-07-24
0487-0201-03ML - Milliliter0487-0201ecfe7467-f851-45ee-89af-25f28f9672d112012-07-24
0487-0201-60ML - Milliliter0487-02018bb731cd-5fdd-493e-a6bb-518f6e17f44512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALBUTEROL SULFATEACTIVE INGREDIENT021SEF3731IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]6
IPRATROPIUM BROMIDEACTIVE INGREDIENTJ697UZ2A9JIPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]6
ALBUTEROLACTIVE MOIETYQF8SVZ843EIPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]6
IPRATROPIUMACTIVE MOIETYGR88G0I6ULIPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]6
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBIPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]6
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XIPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]6
WATERINACTIVE INGREDIENT059QF0KO0RIPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0487-0201IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]14Current NDC, Legacy NDC, 8 package rows20250411_ae35ec1f-526a-49bf-8262-c50e40190d1f.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 SolutionPSN65504330-6c02-4e30-9f32-51393e06f20c14
1437702ipratropium Br 0.5 MG / albuterol sulfate 3 MG in 3 ML Inhalation SolutionPSNae35ec1f-526a-49bf-8262-c50e40190d1f14
1437702albuterol 0.833 MG/ML / ipratropium bromide 0.167 MG/ML Inhalation SolutionSCD65504330-6c02-4e30-9f32-51393e06f20c14
1437702albuterol 0.833 MG/ML / ipratropium bromide 0.167 MG/ML Inhalation SolutionSCDae35ec1f-526a-49bf-8262-c50e40190d1f14
1437702albuterol 2.5 MG (as albuterol sulfate 3 MG) / ipratropium bromide 0.5 MG per 3 ML Inhalation SolutionSY65504330-6c02-4e30-9f32-51393e06f20c14
1437702albuterol 2.5 MG (as albuterol sulfate 3 MG) / ipratropium bromide 0.5 MG per 3 ML Inhalation SolutionSYae35ec1f-526a-49bf-8262-c50e40190d1f14
1437702ipratropium Br 0.5 MG / albuterol sulfate 3 MG in 3 ML Inhalation SolutionPSNa1d9d346-91a5-4f5a-82ed-4ebeaf350a068
1437702albuterol 0.833 MG/ML / ipratropium bromide 0.167 MG/ML Inhalation SolutionSCDa1d9d346-91a5-4f5a-82ed-4ebeaf350a068
1437702albuterol 2.5 MG (as albuterol sulfate 3 MG) / ipratropium bromide 0.5 MG per 3 ML Inhalation SolutionSYa1d9d346-91a5-4f5a-82ed-4ebeaf350a068
1437702ipratropium Br 0.5 MG / albuterol sulfate 3 MG in 3 ML Inhalation SolutionPSN66f32a06-c880-4b5b-837b-951e1e01e0406
1437702albuterol 0.833 MG/ML / ipratropium bromide 0.167 MG/ML Inhalation SolutionSCD66f32a06-c880-4b5b-837b-951e1e01e0406
1437702albuterol 2.5 MG (as albuterol sulfate 3 MG) / ipratropium bromide 0.5 MG per 3 ML Inhalation SolutionSY66f32a06-c880-4b5b-837b-951e1e01e0406
1437702ipratropium Br 0.5 MG / albuterol sulfate 3 MG in 3 ML Inhalation SolutionPSN1fbf9b9b-5c39-292f-e063-6394a90a91a21
1437702albuterol 0.833 MG/ML / ipratropium bromide 0.167 MG/ML Inhalation SolutionSCD1fbf9b9b-5c39-292f-e063-6394a90a91a21
1437702albuterol 2.5 MG (as albuterol sulfate 3 MG) / ipratropium bromide 0.5 MG per 3 ML Inhalation SolutionSY1fbf9b9b-5c39-292f-e063-6394a90a91a21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0487-0201-010048702010130 POUCH in 1 CARTON (0487-0201-01) / 1 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE30 pouch2007-12-310000-00-00NoNoCurrent
0487-0201-020048702010230 POUCH in 1 CARTON (0487-0201-02) / 1 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE30 pouch2007-12-310000-00-00NoNoCurrent
0487-0201-03004870201036 POUCH in 1 CARTON (0487-0201-03) / 5 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE6 pouch2007-12-310000-00-00NoNoCurrent
0487-0201-600048702016012 POUCH in 1 CARTON (0487-0201-60) / 5 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE12 pouch2007-12-310000-00-00NoNoCurrent