FDA.reportPublic FDA data

Tolterodine tartrate

Product NDC
29300-306
11-digit product format
293000306
Labeler code
29300
Product ID
29300-306_1d40a6e0-df38-4fd8-bfea-5d19c9d071ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolterodine tartrate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA216917
Marketing category
ANDA
Marketing start
2024-10-01
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
A216917-001TOLTERODINE TARTRATETOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2024-08-27
A216917-002TOLTERODINE TARTRATETOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2024-08-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216917-001AB
A216917-002AB

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 22:54:322026-06A216917-001TOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2024-08-27a50c72e98297…
2026-08-01 22:54:322026-06A216917-002TOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2024-08-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A216917-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A216917-002AB1a50c72e98297…

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 TARTRATEUnichem Pharmaceuticals (USA), Inc.9710ad7b-93c2-4ec1-95ff-597563be43142024-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216917
application number: ANDA216917
ndc (product): 29300-306

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
9710ad7b-93c2-4ec1-95ff-597563be4314Available 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
29300-306-05Tolterodine tartrate500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5004
29300-306-13Tolterodine tartrate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE304
29300-306-19Tolterodine tartrate90 in 1 BOTTLECAPSULE, EXTENDED RELEASE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-306-13EA - Each29300-30674108097-f94e-435e-9c04-97685cd13b6112025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-306TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]4Current NDC, 3 package rows20241001_9710ad7b-93c2-4ec1-95ff-597563be4314.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855182tolterodine tartrate 2 MG 24HR Extended Release Oral CapsulePSN9710ad7b-93c2-4ec1-95ff-597563be43144
855189tolterodine tartrate 4 MG 24HR Extended Release Oral CapsulePSN9710ad7b-93c2-4ec1-95ff-597563be43144
85518224 HR tolterodine tartrate 2 MG Extended Release Oral CapsuleSCD9710ad7b-93c2-4ec1-95ff-597563be43144
85518924 HR tolterodine tartrate 4 MG Extended Release Oral CapsuleSCD9710ad7b-93c2-4ec1-95ff-597563be43144
855182tolterodine tartrate 2 MG 24 HR Extended Release Oral CapsuleSY9710ad7b-93c2-4ec1-95ff-597563be43144
855189tolterodine tartrate 4 MG 24 HR Extended Release Oral CapsuleSY9710ad7b-93c2-4ec1-95ff-597563be43144

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
29300-306-0529300030605500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29300-306-05) 2024-10-01NoNoCurrent
29300-306-132930003061330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29300-306-13) 2024-10-01NoNoCurrent
29300-306-192930003061990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29300-306-19) 2024-10-01NoNoCurrent