FDA.reportPublic FDA data

Tolterodine tartrate

Product NDC
27241-191
11-digit product format
272410191
Labeler code
27241
Product ID
27241-191_cf018a04-660f-4119-898f-1877a5db8e7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolterodine tartrate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA213397
Marketing category
ANDA
Marketing start
2020-06-25
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
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213397-001TOLTERODINE TARTRATETOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2020-05-19
A213397-002TOLTERODINE TARTRATETOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2020-05-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213397-001AB
A213397-002AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A213397-001TOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2020-05-19a50c72e98297…
2026-08-01 22:54:322026-06A213397-002TOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2020-05-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A213397-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A213397-002AB1a50c72e98297…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tolterodine tartrateTOLTERODINE TARTRATEAjanta Pharma USA Inc.fcaca033-cd08-4b8c-9bad-7b6751faf2c92025-11-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213397
application number: ANDA213397
ndc (product): 27241-191

Additional Listing Data#

Finished product
Yes
Brand name base
Tolterodine tartrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLTERODINE TARTRATE2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5T619TQR3RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
855182Internal RxNorm lookup
855189Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fcaca033-cd08-4b8c-9bad-7b6751faf2c9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b480943b-5b5a-aac0-c5ca-c22f479ac1a1Product name820250325
a932c194-3a9e-a7d8-8961-eb5843129c16Product name620220210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27241-191-05Tolterodine tartrate500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5005
27241-191-30Tolterodine tartrate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE305
27241-191-90Tolterodine tartrate90 in 1 BOTTLECAPSULE, EXTENDED RELEASE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-191-05EA - Each27241-19140cbeeeb-0b54-4453-8f05-a8b7e82e6cd612020-09-14
27241-191-30EA - Each27241-1912f6c02f1-9c1d-448e-9100-3bec228a794712020-09-14
27241-191-90EA - Each27241-19183523ca2-7629-4932-a4f6-e03d6fcc48ce12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-191TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [AJANTA PHARMA USA INC.]4Current NDC, Legacy NDC, 3 package rows20211126_fcaca033-cd08-4b8c-9bad-7b6751faf2c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855182tolterodine tartrate 2 MG 24HR Extended Release Oral CapsulePSNfcaca033-cd08-4b8c-9bad-7b6751faf2c95
855189tolterodine tartrate 4 MG 24HR Extended Release Oral CapsulePSNfcaca033-cd08-4b8c-9bad-7b6751faf2c95
85518224 HR tolterodine tartrate 2 MG Extended Release Oral CapsuleSCDfcaca033-cd08-4b8c-9bad-7b6751faf2c95
85518924 HR tolterodine tartrate 4 MG Extended Release Oral CapsuleSCDfcaca033-cd08-4b8c-9bad-7b6751faf2c95
855182tolterodine tartrate 2 MG 24 HR Extended Release Oral CapsuleSYfcaca033-cd08-4b8c-9bad-7b6751faf2c95
855189tolterodine tartrate 4 MG 24 HR Extended Release Oral CapsuleSYfcaca033-cd08-4b8c-9bad-7b6751faf2c95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
27241-191-0527241019105500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-191-05) 2020-06-250000-00-00NoNoCurrent
27241-191-302724101913030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-191-30) 2020-06-250000-00-00NoNoCurrent
27241-191-902724101919090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-191-90) 2020-06-250000-00-00NoNoCurrent