Home NDC 50090-1382 IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE
Product NDC 50090-1382
11-digit product format 500901382
Labeler code 50090
Product ID 50090-1382_d50406d8-cb32-45b6-be89-08fdab21fea9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ipratropium Bromide and Albuterol Sulfate
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler A-S Medication Solutions
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 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 RLD / RS 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.
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 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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-1382-0 IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE 3 mL in 1 VIAL SOLUTION 3 18 50090-1382-0 IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE 30 in 1 CARTON SOLUTION 30 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-1382 IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [A-S MEDICATION SOLUTIONS] 18 Current NDC, Legacy NDC, 2 package rows 20240612_e452afc2-dc33-4be7-949e-143b2e5f530c.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 ndc (product): 50090-1382 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50090-1382-0 50090138200 30 VIAL in 1 CARTON (50090-1382-0) / 3 mL in 1 VIAL 30 vial 2014-11-28 0000-00-00 No No Current