Ipratropium Bromide and Albuterol Sulfate

Product NDC: 0378-9671
11-digit product format: 003789671
Labeler code: 0378
Product ID: 0378-9671_96603d2c-6783-4f6c-8b3e-de3eaabcc6aa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ipratropium Bromide and Albuterol Sulfate
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA202496
Marketing category: ANDA
Marketing start: 2013-03-01
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 41 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
2026-02-19 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…`
2022-09-29 23:25 UTC	2022-09	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202496-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	2012-10-01	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-09-29 23:25 UTC	2022-09	A202496-001	AN	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202496-001	AN	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
J697UZ2A9J	Internal UNII lookup
021SEF3731	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
23c05e9a-9df5-4978-8831-cf562aa4ba92	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
26005090-31a1-441d-920b-db3101a55d53	Product name	3	20250221
1c39b897-7219-42a1-9f3a-ec86cfd7b04b	Product name	3	20250218
0a278166-c8aa-41b6-b4a5-6ac332bde76a	Product name	1	20230718
c76bcd0f-25eb-471e-b970-1956c95c26c5	Product name	1	20230425
36390b75-5438-47d3-af60-732a654e9025	Product name	2	20220110
387afa72-0c5a-0d6b-ee2c-60c3506659e8	Product name	6	20210518
1b8ea3ec-88bd-98ea-c961-00ae340b5b14	Product name	2	20200220
3aa5a017-61e9-0c89-adef-13e7964d22f0	Product name	3	20171208
6ac73021-459f-435b-b6c5-8c7d6a50c021	Product name	2	20170404
c3c27a99-b8bc-4955-841c-26555f58ee7e	Product name	1	20150421
bc98cf6f-a973-7162-5e30-0e7dd8c56bc3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0378-9671-30	Ipratropium Bromide and Albuterol Sulfate	1 in 1 CARTON	SOLUTION	1	7
0378-9671-31	Ipratropium Bromide and Albuterol Sulfate	3 mL in 1 AMPULE	SOLUTION	3	7
0378-9671-31	Ipratropium Bromide and Albuterol Sulfate	1 in 1 POUCH	SOLUTION	1	7
0378-9671-60	Ipratropium Bromide and Albuterol Sulfate	30 in 1 POUCH	SOLUTION	30	7
0378-9671-60	Ipratropium Bromide and Albuterol Sulfate	2 in 1 CARTON	SOLUTION	2	7
0378-9671-64	Ipratropium Bromide and Albuterol Sulfate	30 in 1 POUCH	SOLUTION	30	7
0378-9671-64	Ipratropium Bromide and Albuterol Sulfate	3 mL in 1 AMPULE	SOLUTION	3	7
0378-9671-93	Ipratropium Bromide and Albuterol Sulfate	30 in 1 CARTON	SOLUTION	30	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-9671-30	ML - Milliliter	0378-9671	fecf8d7a-ca63-4086-a192-cfe09593da7f	1	2016-03-04
0378-9671-31	ML - Milliliter	0378-9671	441e8202-3014-467f-839f-1cb56dd1ff5a	1	2015-05-05
0378-9671-58	ML - Milliliter	0378-9671	e0ed7cbb-725f-41b4-98a8-8e4fbac96aa5	1	2013-10-17
0378-9671-60	ML - Milliliter	0378-9671	ac7fec3f-8285-492f-b246-26b74402bbb7	1	2016-04-04
0378-9671-91	ML - Milliliter	0378-9671	32a69a83-77f5-460b-ac59-cdb791096167	1	2014-04-03
0378-9671-93	ML - Milliliter	0378-9671	f9a81245-211d-421f-9a2b-9b034708627c	1	2013-07-02
0378-9671-98	ML - Milliliter	0378-9671	d5fa01b8-04ef-4d82-bc9d-1bc4f51852f7	1	2015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Albuterol Sulfate	ACTIVE INGREDIENT	021SEF3731	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [MYLAN PHARMACEUTICALS, INC.]	1
Ipratropium Bromide	ACTIVE INGREDIENT	J697UZ2A9J	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [MYLAN PHARMACEUTICALS, INC.]	1
Albuterol	ACTIVE MOIETY	QF8SVZ843E	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [MYLAN PHARMACEUTICALS, INC.]	1
Ipratropium	ACTIVE MOIETY	GR88G0I6UL	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [MYLAN PHARMACEUTICALS, INC.]	1
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [MYLAN PHARMACEUTICALS, INC.]	1
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [MYLAN PHARMACEUTICALS, INC.]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [MYLAN PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-9671	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [MYLAN PHARMACEUTICALS INC.]	7	Current NDC, Legacy NDC, 8 package rows	20190514_23c05e9a-9df5-4978-8831-cf562aa4ba92.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 · 6 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	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 ndc (product): 0378-9671

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1437702	ipratropium Br 0.5 MG / albuterol sulfate 3 MG in 3 ML Inhalation Solution	PSN	23c05e9a-9df5-4978-8831-cf562aa4ba92	7
1437702	albuterol 0.833 MG/ML / ipratropium bromide 0.167 MG/ML Inhalation Solution	SCD	23c05e9a-9df5-4978-8831-cf562aa4ba92	7
1437702	albuterol 2.5 MG (as albuterol sulfate 3 MG) / ipratropium bromide 0.5 MG per 3 ML Inhalation Solution	SY	23c05e9a-9df5-4978-8831-cf562aa4ba92	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-9671-30	00378967130	1 POUCH in 1 CARTON (0378-9671-30) / 30 AMPULE in 1 POUCH (0378-9671-64) / 3 mL in 1 AMPULE	1 pouch	2013-03-01	0000-00-00	No	No	Current
0378-9671-31	00378967131	3 mL in 1 AMPULE	3 ml					Historical
0378-9671-60	00378967160	2 POUCH in 1 CARTON (0378-9671-60) / 30 AMPULE in 1 POUCH / 3 mL in 1 AMPULE	2 pouch	2013-03-01	0000-00-00	No	No	Current
0378-9671-64	00378967164	30 in 1 POUCH						Historical
0378-9671-93	00378967193	30 POUCH in 1 CARTON (0378-9671-93) / 1 AMPULE in 1 POUCH (0378-9671-31) / 3 mL in 1 AMPULE	30 pouch	2013-03-01	0000-00-00	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	Mylan Pharmaceuticals Inc.	2018-12-12	HUMAN PRESCRIPTION DRUG LABEL	7