Ipratropium Bromide and Albuterol Sulfate

Product NDC: 0487-0201
11-digit product format: 004870201
Labeler code: 0487
Product ID: 0487-0201_32473735-b131-709c-e063-6294a90afde8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ipratropium Bromide and Albuterol Sulfate
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: Nephron Pharmaceuticals Corporation
Application: ANDA076749
Marketing category: ANDA
Marketing start: 2007-12-31
Substance: ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
Active strength: 3; .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
A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	ALBUTEROL SULFATE; IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076749-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN		2007-12-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN		2007-12-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN		2007-12-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN		2007-12-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN		2007-12-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN		2007-12-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN		2007-12-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN		2007-12-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076749-001	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION / INHALATION	AN	RS	2007-12-31	`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	A076749-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076749-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076749-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076749-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076749-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076749-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076749-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076749-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076749-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076749-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076749-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076749-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076749-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076749-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076749-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076749-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076749-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076749-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076749-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076749-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076749-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076749-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076749-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076749-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076749-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076749-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076749-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076749-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076749-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076749-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076749-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076749-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076749-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076749-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076749-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076749-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076749-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076749-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076749-001	AN	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076749-001	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	3 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
ae35ec1f-526a-49bf-8262-c50e40190d1f	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
0a278166-c8aa-41b6-b4a5-6ac332bde76a	Product name	1	20230718
c76bcd0f-25eb-471e-b970-1956c95c26c5	Product name	1	20230425
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
36390b75-5438-47d3-af60-732a654e9025	Product name	2	20220110
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
387afa72-0c5a-0d6b-ee2c-60c3506659e8	Product name	6	20210518
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
1b8ea3ec-88bd-98ea-c961-00ae340b5b14	Product name	2	20200220
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
3aa5a017-61e9-0c89-adef-13e7964d22f0	Product name	3	20171208
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
c3c27a99-b8bc-4955-841c-26555f58ee7e	Product name	1	20150421
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
bc98cf6f-a973-7162-5e30-0e7dd8c56bc3	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
0487-0201-01	Ipratropium Bromide and Albuterol Sulfate	30 in 1 CARTON	SOLUTION	30	14
0487-0201-01	Ipratropium Bromide and Albuterol Sulfate	1 in 1 POUCH	SOLUTION	1	14
0487-0201-02	Ipratropium Bromide and Albuterol Sulfate	1 in 1 POUCH	SOLUTION	1	14
0487-0201-02	Ipratropium Bromide and Albuterol Sulfate	30 in 1 CARTON	SOLUTION	30	14
0487-0201-03	Ipratropium Bromide and Albuterol Sulfate	6 in 1 CARTON	SOLUTION	6	14
0487-0201-03	Ipratropium Bromide and Albuterol Sulfate	5 in 1 POUCH	SOLUTION	5	14
0487-0201-60	Ipratropium Bromide and Albuterol Sulfate	12 in 1 CARTON	SOLUTION	12	14
0487-0201-60	Ipratropium Bromide and Albuterol Sulfate	5 in 1 POUCH	SOLUTION	5	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0487-0201-01	ML - Milliliter	0487-0201	636a5388-7d5d-47fa-a169-4ce71bcadfdc	1	2012-07-24
0487-0201-02	ML - Milliliter	0487-0201	e95db3a7-d3f4-4157-bcdf-0cabbb19a484	1	2012-07-24
0487-0201-03	ML - Milliliter	0487-0201	ecfe7467-f851-45ee-89af-25f28f9672d1	1	2012-07-24
0487-0201-60	ML - Milliliter	0487-0201	8bb731cd-5fdd-493e-a6bb-518f6e17f445	1	2012-07-24

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 [CARDINAL HEALTH]	6
ALBUTEROL SULFATE	ACTIVE INGREDIENT	021SEF3731	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]	6
IPRATROPIUM BROMIDE	ACTIVE INGREDIENT	J697UZ2A9J	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [CARDINAL HEALTH]	6
IPRATROPIUM BROMIDE	ACTIVE INGREDIENT	J697UZ2A9J	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]	6
ALBUTEROL	ACTIVE MOIETY	QF8SVZ843E	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [CARDINAL HEALTH]	6
ALBUTEROL	ACTIVE MOIETY	QF8SVZ843E	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]	6
IPRATROPIUM	ACTIVE MOIETY	GR88G0I6UL	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [CARDINAL HEALTH]	6
IPRATROPIUM	ACTIVE MOIETY	GR88G0I6UL	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]	6
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [CARDINAL HEALTH]	6
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]	6
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [CARDINAL HEALTH]	6
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [CARDINAL HEALTH]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0487-0201	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]	14	Current NDC, Legacy NDC, 8 package rows	20250411_ae35ec1f-526a-49bf-8262-c50e40190d1f.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	Rising Pharma Holdings, Inc.	3246dfab-61d7-27ba-e063-6294a90ac180	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076749 application number: ANDA076749
Ipratropium Bromide and Albuterol Sulfate	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE	A-S Medication Solutions	65504330-6c02-4e30-9f32-51393e06f20c	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076749 application number: ANDA076749
Ipratropium Bromide and Albuterol Sulfate	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE	Preferred Pharmaceuticals Inc.	66f32a06-c880-4b5b-837b-951e1e01e040	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076749 application number: ANDA076749
Ipratropium Bromide and Albuterol Sulfate	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE	Chartwell RX, LLC	b444478a-10ce-484f-9039-6383dfb8161e	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076749 application number: ANDA076749
Ipratropium Bromide and Albuterol Sulfate	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE	Nephron Pharmaceuticals Corporation	ae35ec1f-526a-49bf-8262-c50e40190d1f	2025-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076749 application number: ANDA076749 ndc (product): 0487-0201
Ipratropium Bromide and Albuterol Sulfate	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE	Proficient Rx LP	a1d9d346-91a5-4f5a-82ed-4ebeaf350a06	2024-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076749 application number: ANDA076749

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	65504330-6c02-4e30-9f32-51393e06f20c	14
1437702	ipratropium Br 0.5 MG / albuterol sulfate 3 MG in 3 ML Inhalation Solution	PSN	ae35ec1f-526a-49bf-8262-c50e40190d1f	14
1437702	albuterol 0.833 MG/ML / ipratropium bromide 0.167 MG/ML Inhalation Solution	SCD	65504330-6c02-4e30-9f32-51393e06f20c	14
1437702	albuterol 0.833 MG/ML / ipratropium bromide 0.167 MG/ML Inhalation Solution	SCD	ae35ec1f-526a-49bf-8262-c50e40190d1f	14
1437702	albuterol 2.5 MG (as albuterol sulfate 3 MG) / ipratropium bromide 0.5 MG per 3 ML Inhalation Solution	SY	65504330-6c02-4e30-9f32-51393e06f20c	14
1437702	albuterol 2.5 MG (as albuterol sulfate 3 MG) / ipratropium bromide 0.5 MG per 3 ML Inhalation Solution	SY	ae35ec1f-526a-49bf-8262-c50e40190d1f	14
1437702	ipratropium Br 0.5 MG / albuterol sulfate 3 MG in 3 ML Inhalation Solution	PSN	a1d9d346-91a5-4f5a-82ed-4ebeaf350a06	8
1437702	albuterol 0.833 MG/ML / ipratropium bromide 0.167 MG/ML Inhalation Solution	SCD	a1d9d346-91a5-4f5a-82ed-4ebeaf350a06	8
1437702	albuterol 2.5 MG (as albuterol sulfate 3 MG) / ipratropium bromide 0.5 MG per 3 ML Inhalation Solution	SY	a1d9d346-91a5-4f5a-82ed-4ebeaf350a06	8
1437702	ipratropium Br 0.5 MG / albuterol sulfate 3 MG in 3 ML Inhalation Solution	PSN	66f32a06-c880-4b5b-837b-951e1e01e040	6
1437702	albuterol 0.833 MG/ML / ipratropium bromide 0.167 MG/ML Inhalation Solution	SCD	66f32a06-c880-4b5b-837b-951e1e01e040	6
1437702	albuterol 2.5 MG (as albuterol sulfate 3 MG) / ipratropium bromide 0.5 MG per 3 ML Inhalation Solution	SY	66f32a06-c880-4b5b-837b-951e1e01e040	6
1437702	ipratropium Br 0.5 MG / albuterol sulfate 3 MG in 3 ML Inhalation Solution	PSN	1fbf9b9b-5c39-292f-e063-6394a90a91a2	1
1437702	albuterol 0.833 MG/ML / ipratropium bromide 0.167 MG/ML Inhalation Solution	SCD	1fbf9b9b-5c39-292f-e063-6394a90a91a2	1
1437702	albuterol 2.5 MG (as albuterol sulfate 3 MG) / ipratropium bromide 0.5 MG per 3 ML Inhalation Solution	SY	1fbf9b9b-5c39-292f-e063-6394a90a91a2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0487-0201-01	00487020101	30 POUCH in 1 CARTON (0487-0201-01) / 1 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE	30 pouch	2007-12-31	0000-00-00	No	No	Current
0487-0201-02	00487020102	30 POUCH in 1 CARTON (0487-0201-02) / 1 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE	30 pouch	2007-12-31	0000-00-00	No	No	Current
0487-0201-03	00487020103	6 POUCH in 1 CARTON (0487-0201-03) / 5 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE	6 pouch	2007-12-31	0000-00-00	No	No	Current
0487-0201-60	00487020160	12 POUCH in 1 CARTON (0487-0201-60) / 5 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE	12 pouch	2007-12-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg* Inhalation Solution, USP	A-S Medication Solutions	2026-05-22	HUMAN PRESCRIPTION DRUG LABEL	14
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg* Inhalation Solution	Preferred Pharmaceuticals Inc.	2026-05-13	HUMAN PRESCRIPTION DRUG LABEL	6
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg* Inhalation Solution, USP	Nephron Pharmaceuticals Corporation \| Nephron SC, LLC	2025-04-08	HUMAN PRESCRIPTION DRUG LABEL	14
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg* Inhalation Solution	RedPharm Drug	2024-08-15	HUMAN PRESCRIPTION DRUG LABEL	1
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg* Inhalation Solution	REMEDYREPACK INC.	2024-04-15	HUMAN PRESCRIPTION DRUG LABEL	6
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg* Inhalation Solution	Proficient Rx LP	2024-01-01	HUMAN PRESCRIPTION DRUG LABEL	8
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg* Inhalation Solution	Cardinal Health 107, LLC	2023-01-18	HUMAN PRESCRIPTION DRUG LABEL	10
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg* Inhalation Solution	Preferred Pharmaceuticals, Inc.	2020-02-28	HUMAN PRESCRIPTION DRUG LABEL	1
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg* Inhalation Solution	REMEDYREPACK INC.	2019-08-04	HUMAN PRESCRIPTION DRUG LABEL	1