FDA.reportPublic FDA data

Tolterodine Tartrate

Product NDC
16571-127
11-digit product format
165710127
Labeler code
16571
Product ID
16571-127_d56e7ced-4633-4325-8e3d-166c84c05886
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolterodine Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA204721
Marketing category
ANDA
Marketing start
2020-01-24
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
A204721-001TOLTERODINE TARTRATETOLTERODINE TARTRATE1MGTABLET / ORALAB2020-01-24
A204721-002TOLTERODINE TARTRATETOLTERODINE TARTRATE2MGTABLET / ORALAB2020-01-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204721-001AB
A204721-002AB

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 22:54:322026-06A204721-001TOLTERODINE TARTRATE1MGTABLET / ORALAB2020-01-24a50c72e98297…
2026-08-01 22:54:322026-06A204721-002TOLTERODINE TARTRATE2MGTABLET / ORALAB2020-01-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204721-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A204721-002AB1a50c72e98297…

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 TARTRATERising Pharma Holdings, Inc.b9ba8ad2-27f6-4f18-bd84-73659047910e2025-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204721
application number: ANDA204721
ndc (product): 16571-127

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
855178Internal RxNorm lookup
855194Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b9ba8ad2-27f6-4f18-bd84-73659047910eAvailable 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
16571-127-01Tolterodine Tartrate100 in 1 BOTTLETABLET, FILM COATED1003
16571-127-06Tolterodine Tartrate60 in 1 BOTTLETABLET, FILM COATED603
16571-127-50Tolterodine Tartrate500 in 1 BOTTLETABLET, FILM COATED5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-127-50EA - Each16571-1271f2d1808-285d-4974-a264-ff03d7940d4212021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-127TOLTERODINE TARTRATE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]2Current NDC, Legacy NDC, 3 package rows20200915_b9ba8ad2-27f6-4f18-bd84-73659047910e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855178tolterodine tartrate 1 MG Oral TabletPSNb9ba8ad2-27f6-4f18-bd84-73659047910e3
855194tolterodine tartrate 2 MG Oral TabletPSNb9ba8ad2-27f6-4f18-bd84-73659047910e3
855178tolterodine tartrate 1 MG Oral TabletSCDb9ba8ad2-27f6-4f18-bd84-73659047910e3
855194tolterodine tartrate 2 MG Oral TabletSCDb9ba8ad2-27f6-4f18-bd84-73659047910e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16571-127-0116571012701100 TABLET, FILM COATED in 1 BOTTLE (16571-127-01) 2020-01-240000-00-00NoNoCurrent
16571-127-061657101270660 TABLET, FILM COATED in 1 BOTTLE (16571-127-06) 2020-01-240000-00-00NoNoCurrent
16571-127-5016571012750500 TABLET, FILM COATED in 1 BOTTLE (16571-127-50) 2020-01-240000-00-00NoNoCurrent