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 42.

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-263f01610625f2…
2019-09-15 20:21 UTC2019-09A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A075693-001AN1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075693-001AN1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075693-001AN131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075693-001AN16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075693-001AN1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075693-001AN1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075693-001AN103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075693-001AN12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075693-001AN15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075693-001AN1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075693-001AN1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075693-001AN179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075693-001AN1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075693-001AN11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075693-001AN18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075693-001AN15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075693-001AN15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075693-001AN14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075693-001AN174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075693-001AN1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075693-001AN1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075693-001AN187673890dc5c…
2021-03-12 10:30 UTC2021-03A075693-001AN15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075693-001AN18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075693-001AN1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075693-001AN13f01610625f2…
2019-09-15 20:21 UTC2019-09A075693-001AN1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075693-001AN1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075693-001AN16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075693-001AN11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075693-001AN1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075693-001AN1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075693-001AN19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075693-001AN1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075693-001AN13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075693-001AN1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075693-001AN13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075693-001AN13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075693-001AN1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075693-001AN1e64feba35796…

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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

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