Home NDC 50090-1669 Ipratropium Bromide and Albuterol Sulfate
Product NDC 50090-1669
11-digit product format 500901669
Labeler code 50090
Product ID 50090-1669_8fcfdb22-8586-4ad6-8ec9-ab0a9f09ab98
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ipratropium Bromide and Albuterol Sulfate
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler A-S Medication Solutions
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 2027-12-31
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.
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 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.
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 50090-1669-0 Ipratropium Bromide and Albuterol Sulfate 3 mL in 1 VIAL, SINGLE-DOSE SOLUTION 3 14 50090-1669-0 Ipratropium Bromide and Albuterol Sulfate 30 in 1 POUCH SOLUTION 30 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-1669 IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [A-S MEDICATION SOLUTIONS] 12 Current NDC, Legacy NDC, 2 package rows 20230722_65504330-6c02-4e30-9f32-51393e06f20c.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 ndc (product): 50090-1669 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 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50090-1669-0 50090166900 30 VIAL, SINGLE-DOSE in 1 POUCH (50090-1669-0) / 3 mL in 1 VIAL, SINGLE-DOSE 2015-01-28 0000-00-00 No No Current