Ipratropium Bromide

Product NDC: 47335-706
11-digit product format: 473350706
Labeler code: 47335
Product ID: 47335-706_147b55d9-c9f9-4a22-814a-acf834a1864d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ipratropium Bromide
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA207903
Marketing category: ANDA
Marketing start: 2020-02-04
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207903-001	IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION			2017-01-03

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION		2017-01-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION		2017-01-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION		2017-01-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207903-001	IPRATROPIUM BROMIDE	0.02%	SOLUTION / INHALATION	AN	2017-01-03	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A207903-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207903-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207903-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207903-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207903-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207903-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207903-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207903-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207903-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207903-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207903-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207903-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207903-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207903-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207903-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207903-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207903-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207903-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207903-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207903-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207903-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207903-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207903-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207903-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207903-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207903-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207903-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207903-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207903-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207903-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207903-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207903-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207903-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207903-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207903-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207903-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207903-001	AN	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207903-001	AN	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
J697UZ2A9J	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
231ae8f2-1ec9-4e0f-90a8-11d7b6222576	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9ccc399f-9de9-4e86-a0ca-d7a2e7c6c36c	Product name	2	20251106
d953267a-4ca0-4d44-91ad-712cdee8ab38	Product name	2	20250630
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
0a278166-c8aa-41b6-b4a5-6ac332bde76a	Product name	1	20230718
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
6ac73021-459f-435b-b6c5-8c7d6a50c021	Product name	2	20170404
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
47335-706-48	Ipratropium Bromide	2.5 mL in 1 VIAL	SOLUTION	2.5	5
47335-706-48	Ipratropium Bromide	5 in 1 POUCH	SOLUTION	5	5
47335-706-49	Ipratropium Bromide	5 in 1 CARTON	SOLUTION	5	5
47335-706-52	Ipratropium Bromide	6 in 1 CARTON	SOLUTION	6	5
47335-706-52	Ipratropium Bromide	5 in 1 POUCH	SOLUTION	5	5
47335-706-54	Ipratropium Bromide	12 in 1 CARTON	SOLUTION	12	5
47335-706-54	Ipratropium Bromide	5 in 1 POUCH	SOLUTION	5	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47335-706-48	ML - Milliliter	47335-706	a6b0d9f5-a00c-41b1-b5be-4c810d56f048	1	2020-03-10
47335-706-49	ML - Milliliter	47335-706	985a846f-6760-444c-8571-833823177441	1	2020-03-10
47335-706-52	ML - Milliliter	47335-706	8448d47e-a6c5-4315-a8fe-cb9034d9c944	1	2020-03-10
47335-706-54	ML - Milliliter	47335-706	f72cbfe8-f01f-4502-ae28-d24c6cb65f0f	1	2020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47335-706	IPRATROPIUM BROMIDE SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]	5	Current NDC, Legacy NDC, 7 package rows	20220414_231ae8f2-1ec9-4e0f-90a8-11d7b6222576.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ipratropium Bromide	IPRATROPIUM BROMIDE	Sun Pharmaceutical Industries, Inc.	231ae8f2-1ec9-4e0f-90a8-11d7b6222576	2022-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207903 application number: ANDA207903 ndc (product): 47335-706

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
J697UZ2A9J	IPRATROPIUM BROMIDE	66985-17-9	IPRATROPIUM BROMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
836358	ipratropium bromide 0.02 % Inhalation Solution	PSN	231ae8f2-1ec9-4e0f-90a8-11d7b6222576	5
836358	ipratropium bromide 0.2 MG/ML Inhalation Solution	SCD	231ae8f2-1ec9-4e0f-90a8-11d7b6222576	5
836358	ipratropium bromide 0.02 % Inhalation Solution	SY	231ae8f2-1ec9-4e0f-90a8-11d7b6222576	5
836358	ipratropium bromide 0.5 MG per 2.5 ML Inhalation Solution	SY	231ae8f2-1ec9-4e0f-90a8-11d7b6222576	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
47335-706-48	47335070648	2.5 mL in 1 VIAL	2.5 ml					Historical
47335-706-49	47335070649	5 POUCH in 1 CARTON (47335-706-49) / 5 VIAL in 1 POUCH (47335-706-48) / 2.5 mL in 1 VIAL	5 pouch	2020-02-04	0000-00-00	No	No	Current
47335-706-52	47335070652	6 POUCH in 1 CARTON (47335-706-52) / 5 VIAL in 1 POUCH / 2.5 mL in 1 VIAL	6 pouch	2020-02-04	0000-00-00	No	No	Current
47335-706-54	47335070654	12 POUCH in 1 CARTON (47335-706-54) / 5 VIAL in 1 POUCH / 2.5 mL in 1 VIAL	12 pouch	2020-02-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ipratropium Bromide - Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Medicare Limited	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Medicare Limited	2022-04-13	Human Prescription Drug Label	5