Tolterodine Tartrate

Product NDC: 70518-1873
11-digit product format: 705181873
Labeler code: 70518
Product ID: 70518-1873_81dd10fd-f316-fe7c-e053-2991aa0ac9d4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tolterodine Tartrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA077006
Marketing category: ANDA
Marketing start: 2019-02-14
Marketing end: 0000-00-00
Substance: TOLTERODINE TARTRATE
Active strength: 2 mg/1
Pharmacologic classes: Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70518-1873		D	Discontinued by firm		2026-07-31
excluded package	package	70518-1873	70518-1873-0	D	Discontinued by firm		2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077006-001	TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	1MG	TABLET / ORAL	AB		2015-02-23
A077006-002	TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	2MG	TABLET / ORAL	AB		2015-02-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A077006-001	AB
A077006-002	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	A077006-001	TOLTERODINE TARTRATE	1MG	TABLET / ORAL	AB		2015-02-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077006-002	TOLTERODINE TARTRATE	2MG	TABLET / ORAL	AB		2015-02-23	`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	A077006-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077006-002	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tolterodine Tartrate	TOLTERODINE TARTRATE	Teva Pharmaceuticals USA, Inc.	d27e25b5-5d02-419f-b098-41fb162c5872	2022-10-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077006 application number: ANDA077006
Tolterodine Tartrate	TOLTERODINE TARTRATE	Proficient Rx LP	b77f9893-a422-423a-bb27-527377ade36d	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077006 application number: ANDA077006