IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE

Product NDC: 67296-2315
11-digit product format: 672962315
Labeler code: 67296
Product ID: 67296-2315_594bb038-649f-a2d1-e063-6294a90ac940
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ipratropium Bromide and Albuterol Sulfate
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: Redpharm Drug
Application: ANDA202496
Marketing category: ANDA
Marketing start: 2012-10-15
Substance: ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
Active strength: 2.5; .5 mg/3mL; mg/3mL
Pharmacologic classes: Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	ALBUTEROL SULFATE; IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN		2012-10-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202496-001	AN

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 · 43 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
2026-09-14 22:38:34	2026-08	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A202496-001	AN	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202496-001	AN	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202496-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202496-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202496-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202496-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202496-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202496-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202496-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202496-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202496-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202496-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202496-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202496-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202496-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202496-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202496-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202496-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202496-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202496-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202496-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202496-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202496-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202496-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202496-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202496-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202496-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202496-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202496-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202496-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202496-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202496-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202496-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202496-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202496-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202496-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202496-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202496-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202496-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202496-001	AN	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALBUTEROL SULFATE	2.5 mg/3mL
IPRATROPIUM BROMIDE	.5 mg/3mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
021SEF3731	Internal UNII lookup
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
1437702	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
594bb030-e6e5-1da4-e063-6394a90aba55	Available on FDA.report

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE	Redpharm Drug	594bb030-e6e5-1da4-e063-6394a90aba55	2026-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202496 application number: ANDA202496 ndc (product): 67296-2315
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE	Golden State Medical Supply, Inc.	2ebc820b-a423-46ef-8eba-9fbc93daff44	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202496 application number: ANDA202496
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE	Ritedose Pharmaceuticals, LLC	e0dee492-8bf9-4360-be9b-9d6ee1ecb256	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202496 application number: ANDA202496
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE	A-S Medication Solutions	e452afc2-dc33-4be7-949e-143b2e5f530c	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202496 application number: ANDA202496
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE	American Health Packaging	c04c6ec8-1401-424d-8126-63080e36c4b9	2024-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202496 application number: ANDA202496
Ipratropium Bromide and Albuterol Sulfate	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE	Cipla USA Inc.	89d59bd9-c826-413c-8ed9-a1521a0c7cc5	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202496 application number: ANDA202496
Ipratropium Bromide and Albuterol Sulfate	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE	Mylan Pharmaceuticals Inc.	23c05e9a-9df5-4978-8831-cf562aa4ba92	2018-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202496 application number: ANDA202496

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
021SEF3731	ALBUTEROL SULFATE	51022-70-9	ALBUTEROL SULFATE
J697UZ2A9J	IPRATROPIUM BROMIDE	66985-17-9	IPRATROPIUM BROMIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67296-2315-9	67296231509	1 POUCH in 1 CARTON (67296-2315-9) / 30 AMPULE in 1 POUCH / 3 mL in 1 AMPULE	1 pouch	2012-10-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution 0.5 mg / 3 mg per 3 mL (RDP)	Redpharm Drug	2026-08-18	HUMAN PRESCRIPTION DRUG LABEL	1