Home NDC 68180-964 Tiotropium Bromide
Product NDC 68180-964
11-digit product format 681800964
Labeler code 68180
Product ID 68180-964_87de16e4-1447-4bf6-90f6-705829efe684
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tiotropium Bromide
Dosage form CAPSULE
Route ORAL; RESPIRATORY (INHALATION)
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA211287
Marketing category ANDA
Marketing start 2023-08-16
Substance TIOTROPIUM BROMIDE MONOHYDRATE
Active strength 18 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 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 A211287-001 TIOTROPIUM BROMIDE TIOTROPIUM BROMIDE EQ 0.018MG BASE/INH POWDER / INHALATION AB 2023-06-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211287-001 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 2026-08-01 22:54:32 2026-06 A211287-001 TIOTROPIUM BROMIDE EQ 0.018MG BASE/INH POWDER / INHALATION AB 2023-06-20 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A211287-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Tiotropium Bromide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TIOTROPIUM BROMIDE MONOHYDRATE 18 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L64SXO195N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 485032 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 68180-964-12 Tiotropium Bromide 10 in 1 BLISTER PACK CAPSULE 10 9 68180-964-12 Tiotropium Bromide 3 in 1 CARTON CAPSULE 3 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-964 TIOTROPIUM BROMIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.] 8 Current NDC, 2 package rows 20250501_496b38ee-45b6-4bb2-a35e-9023c3b73719.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68180-964-12 68180096412 3 BLISTER PACK in 1 CARTON (68180-964-12) / 10 CAPSULE in 1 BLISTER PACK 3 blister pack 2023-08-16 No No Current