tiotropium bromide

Generic: tiotropium bromide

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tiotropium bromide
Generic Name tiotropium bromide
Labeler lupin pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL RESPIRATORY (INHALATION)
Active Ingredients

tiotropium bromide monohydrate 18 ug/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-964
Product ID 68180-964_87de16e4-1447-4bf6-90f6-705829efe684
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211287
Listing Expiration 2026-12-31
Marketing Start 2023-08-16

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180964
Hyphenated Format 68180-964

Supplemental Identifiers

RxCUI
485032
UPC
0368180964117
UNII
L64SXO195N

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tiotropium bromide (source: ndc)
Generic Name tiotropium bromide (source: ndc)
Application Number ANDA211287 (source: ndc)
Routes
ORAL RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 18 ug/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (68180-964-12) / 10 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (1)

68180-964-12 3 BLISTER PACK in 1 CARTON (68180-964-12) / 10 CAPSULE in 1 BLISTER PACK

Ingredients (1)

tiotropium bromide monohydrate (18 ug/1)

Linked Drug Pages (1)

Tiotropium Bromide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL", "RESPIRATORY (INHALATION)"], "spl_id": "87de16e4-1447-4bf6-90f6-705829efe684", "openfda": {"upc": ["0368180964117"], "unii": ["L64SXO195N"], "rxcui": ["485032"], "spl_set_id": ["496b38ee-45b6-4bb2-a35e-9023c3b73719"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (68180-964-12)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "68180-964-12", "marketing_start_date": "20230816"}], "brand_name": "Tiotropium Bromide", "product_id": "68180-964_87de16e4-1447-4bf6-90f6-705829efe684", "dosage_form": "CAPSULE", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "68180-964", "generic_name": "Tiotropium Bromide", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tiotropium Bromide", "active_ingredients": [{"name": "TIOTROPIUM BROMIDE MONOHYDRATE", "strength": "18 ug/1"}], "application_number": "ANDA211287", "marketing_category": "ANDA", "marketing_start_date": "20230816", "listing_expiration_date": "20261231"}