Home NDC 50090-6288-0 Ipratropium Bromide and Albuterol Sulfate
Product NDC 50090-6288
Requested package NDC 50090-6288-0
11-digit product format 500906288
Labeler code 50090
Product ID 50090-6288_9d9ac819-3bfd-40d8-853c-315676f93c5e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ipratropium Bromide and Albuterol Sulfate
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler A-S Medication Solutions
Application ANDA207875
Marketing category ANDA
Marketing start 2021-11-15
Marketing end 0000-00-00
Substance ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
Active strength 3 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 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE ALBUTEROL SULFATE; IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207875-001 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 RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207875-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2017-08-07 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 50090-6288-0 Ipratropium Bromide and Albuterol Sulfate 30 in 1 CARTON SOLUTION 30 2 50090-6288-0 Ipratropium Bromide and Albuterol Sulfate 3 mL in 1 VIAL SOLUTION 3 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-6288 IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [A-S MEDICATION SOLUTIONS] 2 Legacy NDC, 2 package rows 20221229_a03a3b08-23a8-401a-8305-057069962959.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 · 2 matching rows.
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 50090-6288-0 50090628800 30 VIAL in 1 CARTON (50090-6288-0) > 3 mL in 1 VIAL 30 vial 2022-12-19 0000-00-00 No No Current