Home NDC 65862-906 Ipratropium Bromide and Albuterol Sulfate
Product NDC 65862-906
11-digit product format 658620906
Labeler code 65862
Product ID 65862-906_08febdad-3a3d-f105-e063-6294a90a0b3b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ipratropium Bromide and Albuterol Sulfate
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler Aurobindo Pharma Limited
Application ANDA206532
Marketing category ANDA
Marketing start 2020-07-09
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 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 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE ALBUTEROL SULFATE; IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08
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.
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 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2020-07-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION AN 2020-07-08 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206532-001 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION / INHALATION 2020-07-08 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2020-12-22 03:56 UTC 2020-12 A206532-001 AN 1 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206532-001 AN 1 c0c555d07b60…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65862-906-01 Ipratropium Bromide and Albuterol Sulfate 1 in 1 POUCH SOLUTION 1 4 65862-906-01 Ipratropium Bromide and Albuterol Sulfate 3 mL in 1 VIAL, SINGLE-DOSE SOLUTION 3 4 65862-906-03 Ipratropium Bromide and Albuterol Sulfate 30 in 1 CARTON SOLUTION 30 4 65862-906-05 Ipratropium Bromide and Albuterol Sulfate 5 in 1 POUCH SOLUTION 5 4 65862-906-05 Ipratropium Bromide and Albuterol Sulfate 3 mL in 1 VIAL, SINGLE-DOSE SOLUTION 3 4 65862-906-30 Ipratropium Bromide and Albuterol Sulfate 6 in 1 CARTON SOLUTION 6 4 65862-906-60 Ipratropium Bromide and Albuterol Sulfate 5 in 1 POUCH SOLUTION 5 4 65862-906-60 Ipratropium Bromide and Albuterol Sulfate 12 in 1 CARTON SOLUTION 12 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-906 IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [AUROBINDO PHARMA LIMITED] 4 Current NDC, Legacy NDC, 8 package rows 20231101_370516c4-718f-4a71-bdc8-8822060ccefe.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 · 1 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 65862-906-01 65862090601 1 in 1 POUCH Historical 65862-906-03 65862090603 30 POUCH in 1 CARTON (65862-906-03) / 1 VIAL, SINGLE-DOSE in 1 POUCH (65862-906-01) / 3 mL in 1 VIAL, SINGLE-DOSE 30 pouch 2020-07-09 0000-00-00 No No Current 65862-906-05 65862090605 5 in 1 POUCH Historical 65862-906-30 65862090630 6 POUCH in 1 CARTON (65862-906-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH (65862-906-05) / 3 mL in 1 VIAL, SINGLE-DOSE 6 pouch 2020-07-09 0000-00-00 No No Current 65862-906-60 65862090660 12 POUCH in 1 CARTON (65862-906-60) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE 12 pouch 2020-07-09 0000-00-00 No No Current