FDA.reportPublic FDA data

Ipratropium Bromide

Product NDC
0487-9801
11-digit product format
004879801
Labeler code
0487
Product ID
0487-9801_3249e47e-0ac1-e2a5-e063-6394a90a9993
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Nephron Pharmaceuticals Corporation
Application
ANDA075562
Marketing category
ANDA
Marketing start
2001-09-27
Substance
IPRATROPIUM BROMIDE
Active strength
.5 mg/2.5mL
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IPRATROPIUM BROMIDE.5 mg/2.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ697UZ2A9J
Rxcui836358

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9ccc399f-9de9-4e86-a0ca-d7a2e7c6c36cProduct name220251106
d953267a-4ca0-4d44-91ad-712cdee8ab38Product name220250630
0a278166-c8aa-41b6-b4a5-6ac332bde76aProduct name120230718
6ac73021-459f-435b-b6c5-8c7d6a50c021Product name220170404

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0487-9801-01Ipratropium Bromide30 in 1 CARTONSOLUTION306
0487-9801-01Ipratropium Bromide1 in 1 POUCHSOLUTION16
0487-9801-02Ipratropium Bromide30 in 1 BOXSOLUTION306
0487-9801-02Ipratropium Bromide1 in 1 BAGSOLUTION16
0487-9801-25Ipratropium Bromide25 in 1 POUCHSOLUTION256
0487-9801-25Ipratropium Bromide1 in 1 CARTONSOLUTION16
0487-9801-30Ipratropium Bromide30 in 1 POUCHSOLUTION306
0487-9801-30Ipratropium Bromide1 in 1 CARTONSOLUTION16
0487-9801-60Ipratropium Bromide30 in 1 POUCHSOLUTION306
0487-9801-60Ipratropium Bromide2 in 1 CARTONSOLUTION26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0487-9801-01ML - Milliliter0487-9801ad1b7193-a9d1-4c85-9f5d-1521ae8fad4212012-07-24
0487-9801-02ML - Milliliter0487-9801c03dd482-612e-4d7d-b7f2-fd9c91dcbf6d12012-07-24
0487-9801-25ML - Milliliter0487-98017e8271e5-156b-4364-bd36-1004356c643812012-07-24
0487-9801-30ML - Milliliter0487-98018eb165c5-0a88-43cd-baa7-a2562e1a9c3b12012-07-24
0487-9801-60ML - Milliliter0487-9801291016ab-3e51-4da1-8cd8-796cbcafb41312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IPRATROPIUM BROMIDEACTIVE INGREDIENTJ697UZ2A9JIPRATROPIUM BROMIDE SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]1
IPRATROPIUM BROMIDEACTIVE MOIETYJ697UZ2A9JIPRATROPIUM BROMIDE SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBIPRATROPIUM BROMIDE SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XIPRATROPIUM BROMIDE SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RIPRATROPIUM BROMIDE SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0487-9801IPRATROPIUM BROMIDE SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]6Current NDC, Legacy NDC, 10 package rows20250427_db8095db-d1fd-4099-9fb1-d1ad4e284976.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836358ipratropium bromide 0.02 % Inhalation SolutionPSNdb8095db-d1fd-4099-9fb1-d1ad4e2849766
836358ipratropium bromide 0.2 MG/ML Inhalation SolutionSCDdb8095db-d1fd-4099-9fb1-d1ad4e2849766
836358ipratropium bromide 0.02 % Inhalation SolutionSYdb8095db-d1fd-4099-9fb1-d1ad4e2849766
836358ipratropium bromide 0.5 MG per 2.5 ML Inhalation SolutionSYdb8095db-d1fd-4099-9fb1-d1ad4e2849766
836358ipratropium bromide 0.02 % Inhalation SolutionPSN9eb6a1c2-1e95-4926-a684-b53b8bc95ebd2
836358ipratropium bromide 0.2 MG/ML Inhalation SolutionSCD9eb6a1c2-1e95-4926-a684-b53b8bc95ebd2
836358ipratropium bromide 0.02 % Inhalation SolutionSY9eb6a1c2-1e95-4926-a684-b53b8bc95ebd2
836358ipratropium bromide 0.5 MG per 2.5 ML Inhalation SolutionSY9eb6a1c2-1e95-4926-a684-b53b8bc95ebd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0487-9801-010048798010130 POUCH in 1 CARTON (0487-9801-01) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE30 pouch2001-09-270000-00-00NoNoCurrent
0487-9801-020048798010230 BAG in 1 BOX (0487-9801-02) / 1 POUCH in 1 BAG / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE30 bag2001-09-270000-00-00NoNoCurrent
0487-9801-25004879801251 POUCH in 1 CARTON (0487-9801-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE1 pouch2001-09-270000-00-00NoNoCurrent
0487-9801-30004879801301 POUCH in 1 CARTON (0487-9801-30) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE1 pouch2001-09-270000-00-00NoNoCurrent
0487-9801-60004879801602 POUCH in 1 CARTON (0487-9801-60) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE2 pouch2001-09-270000-00-00NoNoCurrent