Home NDC 24208-399 Ipratropium Bromide
Product NDC 24208-399
11-digit product format 242080399
Labeler code 24208
Product ID 24208-399_24982952-0064-4ed9-8276-210e482c8358
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ipratropium Bromide
Dosage form SPRAY, METERED
Route NASAL
Labeler Bausch & Lomb Incorporated
Application ANDA076103
Marketing category ANDA
Marketing start 2003-03-31
Substance IPRATROPIUM BROMIDE
Active strength 42 ug/1
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 A076103-001 IPRATROPIUM BROMIDE IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076103-001 AB
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 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076103-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2003-03-31 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 42 ug/1
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 1797844 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 24208-399-15 Ipratropium Bromide 165 in 1 BOTTLE, SPRAY SPRAY, METERED 165 11 24208-399-15 Ipratropium Bromide 1 in 1 CARTON SPRAY, METERED 1 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IPRATROPIUM BROMIDE ACTIVE INGREDIENT J697UZ2A9J IPRATROPIUM BROMIDE SPRAY, METERED [BAUSCH & LOMB INCORPORATED] 6 IPRATROPIUM ACTIVE MOIETY GR88G0I6UL IPRATROPIUM BROMIDE SPRAY, METERED [BAUSCH & LOMB INCORPORATED] 6 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 IPRATROPIUM BROMIDE SPRAY, METERED [BAUSCH & LOMB INCORPORATED] 6 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K IPRATROPIUM BROMIDE SPRAY, METERED [BAUSCH & LOMB INCORPORATED] 6 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB IPRATROPIUM BROMIDE SPRAY, METERED [BAUSCH & LOMB INCORPORATED] 6 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X IPRATROPIUM BROMIDE SPRAY, METERED [BAUSCH & LOMB INCORPORATED] 6 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I IPRATROPIUM BROMIDE SPRAY, METERED [BAUSCH & LOMB INCORPORATED] 6 WATER INACTIVE INGREDIENT 059QF0KO0R IPRATROPIUM BROMIDE SPRAY, METERED [BAUSCH & LOMB INCORPORATED] 6 IPRATROPIUM BROMIDE ACTIVE INGREDIENT J697UZ2A9J IPRATROPIUM BROMIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP] 1 IPRATROPIUM BROMIDE ACTIVE INGREDIENT J697UZ2A9J IPRATROPIUM BROMIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.] 1 IPRATROPIUM ACTIVE MOIETY GR88G0I6UL IPRATROPIUM BROMIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP] 1 IPRATROPIUM BROMIDE ACTIVE MOIETY J697UZ2A9J IPRATROPIUM BROMIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.] 1 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 IPRATROPIUM BROMIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP] 1 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 IPRATROPIUM BROMIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K IPRATROPIUM BROMIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K IPRATROPIUM BROMIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB IPRATROPIUM BROMIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB IPRATROPIUM BROMIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X IPRATROPIUM BROMIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X IPRATROPIUM BROMIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I IPRATROPIUM BROMIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I IPRATROPIUM BROMIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP] 1 WATER INACTIVE INGREDIENT 059QF0KO0R IPRATROPIUM BROMIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R IPRATROPIUM BROMIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24208-399 IPRATROPIUM BROMIDE SPRAY, METERED [BAUSCH & LOMB INCORPORATED] 11 Current NDC, Legacy NDC, 2 package rows 20240102_3fd850a2-af0f-4291-af5d-52c8d6094e64.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 Marketing start Marketing end Sample Exclude flag Status 24208-399-15 24208039915 1 BOTTLE, SPRAY in 1 CARTON (24208-399-15) / 165 SPRAY, METERED in 1 BOTTLE, SPRAY 2003-03-31 0000-00-00 No No Current