FDA.reportPublic FDA data

Tolterodine Tartrate

Product NDC
43975-323
11-digit product format
439750323
Labeler code
43975
Product ID
43975-323_361c4d47-0750-6f78-e063-6394a90ab0c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolterodine Tartrate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA204562
Marketing category
ANDA
Marketing start
2019-08-29
Substance
TOLTERODINE TARTRATE
Active strength
4 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204562-001TOLTERODINE TARTRATETOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2019-08-19
A204562-002TOLTERODINE TARTRATETOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2019-08-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204562-001AB
A204562-002AB

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 22:54:322026-06A204562-001TOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2019-08-19a50c72e98297…
2026-08-01 22:54:322026-06A204562-002TOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2019-08-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204562-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A204562-002AB1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tolterodine TartrateTOLTERODINE TARTRATEMajor Pharmaceuticalse4b9ef09-c750-4e35-96fc-e759ba4849d82026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204562
application number: ANDA204562
Tolterodine TartrateTOLTERODINE TARTRATEGolden State Medical Supply, Inc.05b92da2-923b-3c04-e063-6394a90a69a12026-01-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204562
application number: ANDA204562
Tolterodine TartrateTOLTERODINE TARTRATEANI Pharmaceuticals, Inc.fc5bdc4a-a483-4d31-807b-c7f8d88697232025-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204562
application number: ANDA204562
ndc (product): 43975-323

Additional Listing Data#

Finished product
Yes
Brand name base
Tolterodine Tartrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLTERODINE TARTRATE4 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
fc5bdc4a-a483-4d31-807b-c7f8d8869723Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b480943b-5b5a-aac0-c5ca-c22f479ac1a1Product name820250325
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a932c194-3a9e-a7d8-8961-eb5843129c16Product name620220210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43975-323-03Tolterodine Tartrate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE304
43975-323-09Tolterodine Tartrate90 in 1 BOTTLECAPSULE, EXTENDED RELEASE904
43975-323-50Tolterodine Tartrate500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43975-323-03EA - Each43975-32319c050a2-7797-4458-8e6e-0ae977f4068412020-04-20
43975-323-09EA - Each43975-32334fa3f92-048f-4bec-bc88-9ae38c96272812020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43975-323TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 3 package rows20231219_fc5bdc4a-a483-4d31-807b-c7f8d8869723.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855182tolterodine tartrate 2 MG 24HR Extended Release Oral CapsulePSN05b92da2-923b-3c04-e063-6394a90a69a15
855189tolterodine tartrate 4 MG 24HR Extended Release Oral CapsulePSN05b92da2-923b-3c04-e063-6394a90a69a15
85518224 HR tolterodine tartrate 2 MG Extended Release Oral CapsuleSCD05b92da2-923b-3c04-e063-6394a90a69a15
85518924 HR tolterodine tartrate 4 MG Extended Release Oral CapsuleSCD05b92da2-923b-3c04-e063-6394a90a69a15
855182tolterodine tartrate 2 MG 24 HR Extended Release Oral CapsuleSY05b92da2-923b-3c04-e063-6394a90a69a15
855189tolterodine tartrate 4 MG 24 HR Extended Release Oral CapsuleSY05b92da2-923b-3c04-e063-6394a90a69a15
855182tolterodine tartrate 2 MG 24HR Extended Release Oral CapsulePSNfc5bdc4a-a483-4d31-807b-c7f8d88697234
855189tolterodine tartrate 4 MG 24HR Extended Release Oral CapsulePSNfc5bdc4a-a483-4d31-807b-c7f8d88697234
85518224 HR tolterodine tartrate 2 MG Extended Release Oral CapsuleSCDfc5bdc4a-a483-4d31-807b-c7f8d88697234
85518924 HR tolterodine tartrate 4 MG Extended Release Oral CapsuleSCDfc5bdc4a-a483-4d31-807b-c7f8d88697234
855182tolterodine tartrate 2 MG 24 HR Extended Release Oral CapsuleSYfc5bdc4a-a483-4d31-807b-c7f8d88697234
855189tolterodine tartrate 4 MG 24 HR Extended Release Oral CapsuleSYfc5bdc4a-a483-4d31-807b-c7f8d88697234

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43975-323-034397503230330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-323-03) 2019-08-290000-00-00NoNoCurrent
43975-323-094397503230990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-323-09) 2019-08-290000-00-00NoNoCurrent
43975-323-5043975032350500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-323-50) 2019-08-290000-00-00NoNoCurrent