Ipratropium Bromide

Product NDC
72162-2143
11-digit product format
721622143
Labeler code
72162
Product ID
72162-2143_0b496d6c-b45d-49f7-a32b-8913fef91546
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide
Dosage form
SPRAY
Route
NASAL
Labeler
Bryant Ranch Prepack
Application
ANDA076664
Marketing category
ANDA
Marketing start
2003-11-05
Substance
IPRATROPIUM BROMIDE
Active strength
21 ug/1
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
A076664-001IPRATROPIUM BROMIDEIPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076664-001AB

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 06:07:402026-07A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-053f01610625f2…
2019-09-15 20:21 UTC2019-09A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076664-001IPRATROPIUM BROMIDE0.021MG/SPRAYSPRAY, METERED / NASALABRS2003-11-05e64feba35796…

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 06:07:402026-07A076664-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076664-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076664-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076664-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076664-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076664-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076664-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076664-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076664-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076664-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076664-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076664-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076664-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076664-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076664-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076664-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076664-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076664-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076664-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076664-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076664-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076664-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076664-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076664-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076664-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076664-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076664-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076664-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076664-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076664-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076664-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076664-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076664-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076664-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076664-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076664-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076664-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076664-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076664-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076664-001AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Ipratropium Bromide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IPRATROPIUM BROMIDE21 ug/1

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
1797833Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fcf20db7-091d-40de-8755-03773fc47eddAvailable 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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
0a278166-c8aa-41b6-b4a5-6ac332bde76aProduct name120230718
6ac73021-459f-435b-b6c5-8c7d6a50c021Product name220170404

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2143-3Ipratropium Bromide1 in 1 CARTONSPRAY1100
72162-2143-3Ipratropium Bromide345 in 1 BOTTLE, SPRAYSPRAY345100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2143-3ML - Milliliter72162-2143188c6c33-32fc-49f4-84fc-b7e953dcb43112024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2143IPRATROPIUM BROMIDE SPRAY [BRYANT RANCH PREPACK]100Current NDC, 2 package rows20231208_fcf20db7-091d-40de-8755-03773fc47edd.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ipratropium BromideIPRATROPIUM BROMIDEBryant Ranch Prepackfcf20db7-091d-40de-8755-03773fc47edd2023-12-07Exact identifier
application applno (ANDA): 076664
application number: ANDA076664
ndc (product): 72162-2143
Ipratropium BromideIPRATROPIUM BROMIDEHikma Pharmaceuticals USA Inc.05c56190-e346-4674-a4f8-049ce632ce2d2022-07-01Exact identifier
application applno (ANDA): 076664
application number: ANDA076664

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797833ipratropium Br 21 MCG/ACTUAT (0.03 % ) Metered Dose Nasal SprayPSNfcf20db7-091d-40de-8755-03773fc47edd100
1797833ipratropium bromide 0.021 MG/ACTUAT Metered Dose Nasal SpraySCDfcf20db7-091d-40de-8755-03773fc47edd100
1797833ipratropium bromide 21 MCG/ACTUAT Metered Dose Nasal SpraySYfcf20db7-091d-40de-8755-03773fc47edd100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2143-3721622143031 BOTTLE, SPRAY in 1 CARTON (72162-2143-3) / 345 SPRAY in 1 BOTTLE, SPRAY2023-12-07NoNoCurrent