Home NDC 85766-242 IPRATROPIUM BROMIDE
Product NDC 85766-242
11-digit product format 857660242
Labeler code 85766
Product ID 85766-242_568fa03b-f12a-a131-e063-6294a90a66b8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name IPRATROPIUM BROMIDE
Dosage form SPRAY, METERED
Route NASAL
Labeler Sportpharm LLC
Application ANDA217886
Marketing category ANDA
Marketing start 2025-07-03
Substance IPRATROPIUM BROMIDE
Active strength 42 ug/1
Pharmacologic classes Anticholinergic [EPC]; Cholinergic Antagonists [MoA]
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A217886-001 IPRATROPIUM BROMIDE IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2025-01-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217886-001 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.
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 2026-02-19 14:30 UTC 2026-02 A217886-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2025-01-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217886-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2025-01-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217886-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2025-01-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217886-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2025-01-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217886-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2025-01-27 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217886-001 IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED / NASAL AB 2025-01-27 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base IPRATROPIUM BROMIDE
Listing expiration 2027-12-31 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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Status 85766-242-15 85766024215 1 BOTTLE, SPRAY in 1 CARTON (85766-242-15) / 165 SPRAY, METERED in 1 BOTTLE, SPRAY 2026-07-14 0 Current