FDA.reportPublic FDA data

Ipratropium Bromide

Product NDC
0378-7970
11-digit product format
003787970
Labeler code
0378
Product ID
0378-7970_2c5fc3b9-e3f3-4120-947a-815d30502a3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA075693
Marketing category
ANDA
Marketing start
2010-11-09
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075693-001IPRATROPIUM BROMIDEIPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A075693-001AN

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075693-001AN1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ipratropium BromideIPRATROPIUM BROMIDECardinal Health 107, LLC6b730dd7-4d93-403a-bfd2-fa0efa298b752026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075693
application number: ANDA075693
Ipratropium BromideIPRATROPIUM BROMIDECardinal Health 107, LLC51350fab-a919-4d97-9d0c-d9dc7286244c2026-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075693
application number: ANDA075693
Ipratropium BromideIPRATROPIUM BROMIDERedpharm Drug52c63e41-dbbc-d9d7-e063-6294a90a30c92026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075693
application number: ANDA075693
Ipratropium BromideIPRATROPIUM BROMIDERitedose Pharmaceuticals, LLC22479633-624a-4251-ad3c-1dcba5d503fb2025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075693
application number: ANDA075693
Ipratropium BromideIPRATROPIUM BROMIDENuCare Pharmaceuticals, Inc.2b9b619a-5e2a-73ef-e063-6394a90a97fe2025-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075693
application number: ANDA075693
Ipratropium BromideIPRATROPIUM BROMIDEA-S Medication Solutions7159cf05-da58-4eb9-9e6d-a7f24eec5f462025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075693
application number: ANDA075693
Ipratropium BromideIPRATROPIUM BROMIDEAmerican Health Packaging8927f392-4c88-4ac1-a934-c444ecf6b2c82024-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075693
application number: ANDA075693
Ipratropium BromideIPRATROPIUM BROMIDEA-S Medication Solutions9f7b2f09-e831-4e15-b226-5cef3b613bd12023-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075693
application number: ANDA075693
Ipratropium BromideIPRATROPIUM BROMIDEMylan Pharmaceuticals Inc.f625d3e3-c175-4d9a-99ea-dab410b262f12013-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075693
application number: ANDA075693
ndc (product): 0378-7970

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
J697UZ2A9JInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
836358Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f625d3e3-c175-4d9a-99ea-dab410b262f1Available on FDA.report

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
0378-7970-31Ipratropium Bromide1 in 1 POUCHSOLUTION14
0378-7970-31Ipratropium Bromide2.5 mL in 1 AMPULESOLUTION2.54
0378-7970-52Ipratropium Bromide1 in 1 CARTONSOLUTION14
0378-7970-55Ipratropium Bromide30 in 1 CARTONSOLUTION304
0378-7970-62Ipratropium Bromide2.5 mL in 1 AMPULESOLUTION2.54
0378-7970-62Ipratropium Bromide25 in 1 POUCHSOLUTION254
0378-7970-64Ipratropium Bromide30 in 1 POUCHSOLUTION304
0378-7970-64Ipratropium Bromide2.5 mL in 1 AMPULESOLUTION2.54
0378-7970-91Ipratropium Bromide30 in 1 POUCHSOLUTION304
0378-7970-91Ipratropium Bromide2 in 1 CARTONSOLUTION24
0378-7970-93Ipratropium Bromide1 in 1 CARTONSOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-7970-31ML - Milliliter0378-79702b3da5eb-0852-4f66-9f58-796625914bcd12018-08-13
0378-7970-52ML - Milliliter0378-797086bf2561-e12e-4a92-aa68-8bfc994615f712013-07-02
0378-7970-55ML - Milliliter0378-7970ad365a62-39b0-4634-b4c5-96d45221824712013-11-04
0378-7970-91ML - Milliliter0378-79704a1b06ed-30d5-495a-8a24-7196c4ad0fa112013-07-02
0378-7970-93ML - Milliliter0378-79703c8f2a0c-8326-44eb-a420-0c6509f671ac12013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Ipratropium BromideACTIVE INGREDIENTJ697UZ2A9JIPRATROPIUM BROMIDE SOLUTION [MYLAN PHARMACEUTICALS, INC.]2
IpratropiumACTIVE MOIETYGR88G0I6ULIPRATROPIUM BROMIDE SOLUTION [MYLAN PHARMACEUTICALS, INC.]2
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBIPRATROPIUM BROMIDE SOLUTION [MYLAN PHARMACEUTICALS, INC.]2
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XIPRATROPIUM BROMIDE SOLUTION [MYLAN PHARMACEUTICALS, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RIPRATROPIUM BROMIDE SOLUTION [MYLAN PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-7970IPRATROPIUM BROMIDE SOLUTION [MYLAN PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 11 package rows20190523_f625d3e3-c175-4d9a-99ea-dab410b262f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836358ipratropium bromide 0.02 % Inhalation SolutionPSNf625d3e3-c175-4d9a-99ea-dab410b262f14
836358ipratropium bromide 0.2 MG/ML Inhalation SolutionSCDf625d3e3-c175-4d9a-99ea-dab410b262f14
836358ipratropium bromide 0.02 % Inhalation SolutionSYf625d3e3-c175-4d9a-99ea-dab410b262f14
836358ipratropium bromide 0.5 MG per 2.5 ML Inhalation SolutionSYf625d3e3-c175-4d9a-99ea-dab410b262f14
836358ipratropium bromide 0.02 % Inhalation SolutionPSN9f7b2f09-e831-4e15-b226-5cef3b613bd12
836358ipratropium bromide 0.2 MG/ML Inhalation SolutionSCD9f7b2f09-e831-4e15-b226-5cef3b613bd12
836358ipratropium bromide 0.02 % Inhalation SolutionSY9f7b2f09-e831-4e15-b226-5cef3b613bd12
836358ipratropium bromide 0.5 MG per 2.5 ML Inhalation SolutionSY9f7b2f09-e831-4e15-b226-5cef3b613bd12
836358ipratropium bromide 0.02 % Inhalation SolutionPSN2b9b619a-5e2a-73ef-e063-6394a90a97fe1
836358ipratropium bromide 0.2 MG/ML Inhalation SolutionSCD2b9b619a-5e2a-73ef-e063-6394a90a97fe1
836358ipratropium bromide 0.02 % Inhalation SolutionSY2b9b619a-5e2a-73ef-e063-6394a90a97fe1
836358ipratropium bromide 0.5 MG per 2.5 ML Inhalation SolutionSY2b9b619a-5e2a-73ef-e063-6394a90a97fe1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-7970-31003787970311 in 1 POUCHHistorical
0378-7970-52003787970521 POUCH in 1 CARTON (0378-7970-52) / 25 AMPULE in 1 POUCH (0378-7970-62) / 2.5 mL in 1 AMPULE1 pouch2010-11-090000-00-00NoNoCurrent
0378-7970-550037879705530 POUCH in 1 CARTON (0378-7970-55) / 1 AMPULE in 1 POUCH (0378-7970-31) / 2.5 mL in 1 AMPULE30 pouch2010-11-090000-00-00NoNoCurrent
0378-7970-62003787970622.5 mL in 1 AMPULE2.5 mlHistorical
0378-7970-640037879706430 in 1 POUCHHistorical
0378-7970-91003787970912 POUCH in 1 CARTON (0378-7970-91) / 30 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE2 pouch2010-11-090000-00-00NoNoCurrent
0378-7970-93003787970931 POUCH in 1 CARTON (0378-7970-93) / 30 AMPULE in 1 POUCH (0378-7970-64) / 2.5 mL in 1 AMPULE1 pouch2010-11-090000-00-00NoNoCurrent