Home NDC 65862-905 Ipratropium bromide
Product NDC 65862-905
11-digit product format 658620905
Labeler code 65862
Product ID 65862-905_08eada61-404a-b5f8-e063-6294a90a74e7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ipratropium bromide
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler Aurobindo Pharma Limited
Application ANDA206543
Marketing category ANDA
Marketing start 2016-10-27
Substance IPRATROPIUM BROMIDE
Active strength .5 mg/2.5mL
Pharmacologic classes Anticholinergic [EPC], Cholinergic Antagonists [MoA]
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 42 .
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 A206543-001 IPRATROPIUM BROMIDE IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206543-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206543-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2016-10-27 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ipratropium bromide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IPRATROPIUM BROMIDE .5 mg/2.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 836358 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 65862-905-01 Ipratropium bromide 2.5 mL in 1 VIAL, SINGLE-DOSE SOLUTION 2.5 5 65862-905-01 Ipratropium bromide 1 in 1 POUCH SOLUTION 1 5 65862-905-03 Ipratropium bromide 30 in 1 CARTON SOLUTION 30 5 65862-905-25 Ipratropium bromide 25 in 1 POUCH SOLUTION 25 5 65862-905-25 Ipratropium bromide 1 in 1 CARTON SOLUTION 1 5 65862-905-30 Ipratropium bromide 1 in 1 CARTON SOLUTION 1 5 65862-905-33 Ipratropium bromide 30 in 1 POUCH SOLUTION 30 5 65862-905-33 Ipratropium bromide 2.5 mL in 1 VIAL, SINGLE-DOSE SOLUTION 2.5 5 65862-905-60 Ipratropium bromide 2 in 1 CARTON SOLUTION 2 5 65862-905-60 Ipratropium bromide 30 in 1 POUCH SOLUTION 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-905 IPRATROPIUM BROMIDE SOLUTION [AUROBINDO PHARMA LIMITED] 5 Current NDC, Legacy NDC, 10 package rows 20231031_ff2b6bda-4acd-41fd-8970-458c5265df21.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 65862-905-01 65862090501 2.5 mL in 1 VIAL, SINGLE-DOSE 2.5 ml Historical 65862-905-03 65862090503 30 POUCH in 1 CARTON (65862-905-03) / 1 VIAL, SINGLE-DOSE in 1 POUCH (65862-905-01) / 2.5 mL in 1 VIAL, SINGLE-DOSE 30 pouch 2016-10-27 0000-00-00 No No Current 65862-905-25 65862090525 1 POUCH in 1 CARTON (65862-905-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE 1 pouch 2016-10-27 0000-00-00 No No Current 65862-905-30 65862090530 1 POUCH in 1 CARTON (65862-905-30) / 30 VIAL, SINGLE-DOSE in 1 POUCH (65862-905-33) / 2.5 mL in 1 VIAL, SINGLE-DOSE 1 pouch 2016-10-27 0000-00-00 No No Current 65862-905-33 65862090533 30 in 1 POUCH Historical 65862-905-60 65862090560 2 POUCH in 1 CARTON (65862-905-60) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE 2 pouch 2016-10-27 0000-00-00 No No Current