Ipratropium Bromide and Albuterol Sulfate Solution 0.5 mg/3 mg per 3 mL

Manufacturer: The Ritedose Corporation
Effective date: 2020-01-29
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-01 23:42:33

Label at a glance#

ProductIpratropium Bromide and Albuterol Sulfate

Active ingredientALBUTEROL SULFATE, IPRATROPIUM BROMIDE

Label structure4 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution

0.5 mg/3 mg per 3 mL

30 x 3 mL Sterile Unit-Dose Vials.

Rx Only

FOR INHALATION USE ONLY

Principal Display Panel - Ipratropium Bromide and Albuterol Sulfate Inhalation Solution 0.5 mg/3 mg per 3 mL (AHP) 30 ct Brick Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 60687- 405-83

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution

0.5 mg/3 mg per 3 mL

30 x 3 mL Sterile Unit-Dose Vials.

Rx Only

FOR INHALATION USE ONLY

Ipra-Alb 30 ct Singles Carton

Principal Display Panel - Ipratropium Bromide and Albuterol Sulfate Inhalation Solution 0.5 mg/3 mg per 3 mL (GSMS) 30 ct Brick Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 60429-975-30

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution

0.5 mg/3 mg per 3 mL

Rx Only

30 x 3 mL Sterile Unit-Dose (1 pouch of 30 - 3 mL vials)

GSMS I-A 30ct Carton

Principal Display Panel - Ipratropium Bromide and Albuterol Sulfate Inhalation Solution 0.5 mg/3 mg per 3 mL (GSMS) 60 ct Brick Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 60429-975-60

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution

0.5 mg/3 mg per 3 mL

Rx Only

60 x 3 mL Sterile Unit-Dose Vials (2 pouches of 30 - 3 mL vials)

GSMS I-A 60ct Carton

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

Ipratropium Bromide and Albuterol Sulfate
ALBUTEROL SULFATE
ALBUTEROL
IPRATROPIUM BROMIDE
IPRATROPIUM
IPRATROPIUM BROMIDE ANHYDROUS
WATER
HYDROCHLORIC ACID
SODIUM CHLORIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65302-047	65302-047-01
65302-053	65302-053-60, 65302-053-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALBUTEROL SULFATE	021SEF3731	ACTIM
IPRATROPIUM BROMIDE	J697UZ2A9J	ACTIR
WATER	059QF0KO0R	IACT
HYDROCHLORIC ACID	QTT17582CB	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
ALBUTEROL SULFATE	021SEF3731	ACTIM
IPRATROPIUM BROMIDE	J697UZ2A9J	ACTIR
WATER	059QF0KO0R	IACT
HYDROCHLORIC ACID	QTT17582CB	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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…`

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
9adb9fa3-610d-0edf-e053-2a95a90aed18			9adb9fa3-610c-0edf-e053-2a95a90aed18	2019-12-29		Exact identifier spl set id: 9adb9fa3-610c-0edf-e053-2a95a90aed18

Reported adverse events (FAERS/openFDA)#

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