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 43.

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A211287-001	TIOTROPIUM BROMIDE	EQ 0.018MG BASE/INH	POWDER / INHALATION	AB	2023-06-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211287-001	TIOTROPIUM BROMIDE	EQ 0.018MG BASE/INH	POWDER / INHALATION	AB	2023-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211287-001	TIOTROPIUM BROMIDE	EQ 0.018MG BASE/INH	POWDER / INHALATION	AB	2023-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211287-001	TIOTROPIUM BROMIDE	EQ 0.018MG BASE/INH	POWDER / INHALATION	AB	2023-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211287-001	TIOTROPIUM BROMIDE	EQ 0.018MG BASE/INH	POWDER / INHALATION	AB	2023-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211287-001	TIOTROPIUM BROMIDE	EQ 0.018MG BASE/INH	POWDER / INHALATION	AB	2023-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211287-001	TIOTROPIUM BROMIDE	EQ 0.018MG BASE/INH	POWDER / INHALATION	AB	2023-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211287-001	TIOTROPIUM BROMIDE	EQ 0.018MG BASE/INH	POWDER / INHALATION	AB	2023-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211287-001	TIOTROPIUM BROMIDE	EQ 0.018MG BASE/INH	POWDER / INHALATION	AB	2023-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211287-001	TIOTROPIUM BROMIDE	EQ 0.018MG BASE/INH	POWDER / INHALATION	AB	2023-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211287-001	TIOTROPIUM BROMIDE	EQ 0.018MG BASE/INH	POWDER / INHALATION	AB	2023-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211287-001	TIOTROPIUM BROMIDE	EQ 0.018MG BASE/INH	POWDER / INHALATION	AB	2023-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211287-001	TIOTROPIUM BROMIDE	EQ 0.018MG BASE/INH	POWDER / INHALATION	AB	2023-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211287-001	TIOTROPIUM BROMIDE	EQ 0.018MG BASE/INH	POWDER / INHALATION	AB	2023-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211287-001	TIOTROPIUM BROMIDE	EQ 0.018MG BASE/INH	POWDER / INHALATION	AB	2023-06-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211287-001	TIOTROPIUM BROMIDE	EQ 0.018MG BASE/INH	POWDER / INHALATION	AB	2023-06-20	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211287-001	TIOTROPIUM BROMIDE	EQ 0.018MG BASE/INH	POWDER / INHALATION	AB	2023-06-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211287-001	TIOTROPIUM BROMIDE	EQ 0.018MG BASE/INH	POWDER / INHALATION	AB	2023-06-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211287-001	TIOTROPIUM BROMIDE	EQ 0.018MG BASE/INH	POWDER / INHALATION	AB	2023-06-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211287-001	TIOTROPIUM BROMIDE	EQ 0.018MG BASE/INH	POWDER / INHALATION	AB	2023-06-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211287-001	TIOTROPIUM BROMIDE	EQ 0.018MG BASE/INH	POWDER / INHALATION	AB	2023-06-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211287-001	TIOTROPIUM BROMIDE	EQ 0.018MG BASE/INH	POWDER / INHALATION	AB	2023-06-20	`a67488948f0b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	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
2026-09-14 22:38:34	2026-08	A211287-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211287-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211287-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211287-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211287-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211287-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211287-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211287-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211287-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211287-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211287-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211287-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211287-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211287-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211287-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211287-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211287-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211287-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211287-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211287-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211287-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211287-001	AB	1	`a67488948f0b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211287-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
496b38ee-45b6-4bb2-a35e-9023c3b73719	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
48c4d28d-b099-457f-b725-6536a67545d9	Product name	1	20240723
e5bad22a-8b64-476c-b12b-bcb1efd8adfc	Product name	3	20210727
b2bc1652-3709-4d21-bd76-c433f7f7103e	Product name	1	20150610

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-964-11	EA - Each	68180-964	413ef10c-cb1b-4788-b954-bbb8f1cbcbc3	1	2023-09-05
68180-964-12	EA - Each	68180-964	051c57e3-2514-409d-8ba0-08abc4a4c010	1	2023-09-05

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

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tiotropium Bromide	TIOTROPIUM BROMIDE	Lupin Pharmaceuticals, Inc.	496b38ee-45b6-4bb2-a35e-9023c3b73719	2025-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211287 application number: ANDA211287 ndc (product): 68180-964

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L64SXO195N	TIOTROPIUM BROMIDE MONOHYDRATE	411207-31-3	TIOTROPIUM BROMIDE MONOHYDRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
485032	tiotropium 18 MCG Inhalation Powder	PSN	496b38ee-45b6-4bb2-a35e-9023c3b73719	9
485032	tiotropium 0.018 MG Inhalation Powder	SCD	496b38ee-45b6-4bb2-a35e-9023c3b73719	9
485032	tiotropium 18 MCG (tiotropium bromide 22.5 MCG) Inhalation Powder	SY	496b38ee-45b6-4bb2-a35e-9023c3b73719	9
485032	tiotropium 18 MCG Inhalation Powder	SY	496b38ee-45b6-4bb2-a35e-9023c3b73719	9

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tiotropium Bromide - Lupin Pharmaceuticals, Inc.	Lupin Pharmaceuticals, Inc.	2025-11-11	HUMAN PRESCRIPTION DRUG LABEL	9