FDA.reportPublic FDA data

Tolterodine Tartrate

Product NDC
70436-160
11-digit product format
704360160
Labeler code
70436
Product ID
70436-160_44e07d95-cc64-cae9-e063-6294a90abc45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolterodine Tartrate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Slate Run Pharmaceuticals, LLC
Application
ANDA213858
Marketing category
ANDA
Marketing start
2021-04-12
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
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
A213858-001TOLTERODINE TARTRATETOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2021-02-02
A213858-002TOLTERODINE TARTRATETOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2021-02-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213858-001AB
A213858-002AB

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 22:54:322026-06A213858-001TOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2021-02-02a50c72e98297…
2026-08-01 22:54:322026-06A213858-002TOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2021-02-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A213858-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A213858-002AB1a50c72e98297…

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 TARTRATESlate Run Pharmaceuticals, LLCbbbee85a-e5e2-24ec-e053-2995a90acfd82025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213858
application number: ANDA213858
ndc (product): 70436-160

Additional Listing Data#

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

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
bbbee85a-e5e2-24ec-e053-2995a90acfd8Available 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
70436-160-02Tolterodine Tartrate500 in 1 BOTTLECAPSULE, EXTENDED RELEASE50013
70436-160-04Tolterodine Tartrate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3013
70436-160-06Tolterodine Tartrate90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70436-160-02EA - Each70436-160f5e19586-237e-4b35-b9a8-4960d4ad513712021-05-05
70436-160-04EA - Each70436-1602c8c86f7-52b5-48df-8671-17513ad8767112021-05-05
70436-160-06EA - Each70436-160f53aeb28-0417-4499-90d5-d65d03eb380a12021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-160TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [SLATE RUN PHARMACEUTICALS, LLC]12Current NDC, Legacy NDC, 3 package rows20241120_bbbee85a-e5e2-24ec-e053-2995a90acfd8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855182tolterodine tartrate 2 MG 24HR Extended Release Oral CapsulePSNbbbee85a-e5e2-24ec-e053-2995a90acfd813
855189tolterodine tartrate 4 MG 24HR Extended Release Oral CapsulePSNbbbee85a-e5e2-24ec-e053-2995a90acfd813
85518224 HR tolterodine tartrate 2 MG Extended Release Oral CapsuleSCDbbbee85a-e5e2-24ec-e053-2995a90acfd813
85518924 HR tolterodine tartrate 4 MG Extended Release Oral CapsuleSCDbbbee85a-e5e2-24ec-e053-2995a90acfd813
855182tolterodine tartrate 2 MG 24 HR Extended Release Oral CapsuleSYbbbee85a-e5e2-24ec-e053-2995a90acfd813
855189tolterodine tartrate 4 MG 24 HR Extended Release Oral CapsuleSYbbbee85a-e5e2-24ec-e053-2995a90acfd813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70436-160-0270436016002500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-160-02) 2021-04-120000-00-00NoNoCurrent
70436-160-047043601600430 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-160-04) 2021-04-120000-00-00NoNoCurrent
70436-160-067043601600690 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-160-06) 2021-04-120000-00-00NoNoCurrent