Home NDC 0487-9801 Ipratropium Bromide
Product NDC 0487-9801
11-digit product format 004879801
Labeler code 0487
Product ID 0487-9801_3249e47e-0ac1-e2a5-e063-6394a90a9993
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ipratropium Bromide
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler Nephron Pharmaceuticals Corporation
Application ANDA075562
Marketing category ANDA
Marketing start 2001-09-27
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 A075562-001 IPRATROPIUM BROMIDE IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075562-001 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 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075562-001 IPRATROPIUM BROMIDE 0.02% SOLUTION / INHALATION AN 2001-09-27 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# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0487-9801 IPRATROPIUM BROMIDE SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION] 6 Current NDC, Legacy NDC, 10 package rows 20250427_db8095db-d1fd-4099-9fb1-d1ad4e284976.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 · 3 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 0487-9801-01 00487980101 30 POUCH in 1 CARTON (0487-9801-01) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE 30 pouch 2001-09-27 0000-00-00 No No Current 0487-9801-02 00487980102 30 BAG in 1 BOX (0487-9801-02) / 1 POUCH in 1 BAG / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE 30 bag 2001-09-27 0000-00-00 No No Current 0487-9801-25 00487980125 1 POUCH in 1 CARTON (0487-9801-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE 1 pouch 2001-09-27 0000-00-00 No No Current 0487-9801-30 00487980130 1 POUCH in 1 CARTON (0487-9801-30) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE 1 pouch 2001-09-27 0000-00-00 No No Current 0487-9801-60 00487980160 2 POUCH in 1 CARTON (0487-9801-60) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE 2 pouch 2001-09-27 0000-00-00 No No Current