FDA.reportPublic FDA data

tadalafil

Product NDC
35573-460
11-digit product format
355730460
Labeler code
35573
Product ID
35573-460_da1eee2b-ebe6-4af3-ad52-2b349a360a9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Burel Pharmaceuticals, LLC
Application
ANDA215556
Marketing category
ANDA
Marketing start
2023-04-01
Substance
TADALAFIL
Active strength
2.5 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215556-001TADALAFILTADALAFIL2.5MGTABLET / ORALAB12021-11-04
A215556-002TADALAFILTADALAFIL5MGTABLET / ORALAB12021-11-04
A215556-003TADALAFILTADALAFIL10MGTABLET / ORALAB12021-11-04
A215556-004TADALAFILTADALAFIL20MGTABLET / ORALAB12021-11-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A215556-001AB1
A215556-002AB1
A215556-003AB1
A215556-004AB1

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 22:54:322026-06A215556-001TADALAFIL2.5MGTABLET / ORALAB12021-11-04a50c72e98297…
2026-08-01 22:54:322026-06A215556-002TADALAFIL5MGTABLET / ORALAB12021-11-04a50c72e98297…
2026-08-01 22:54:322026-06A215556-003TADALAFIL10MGTABLET / ORALAB12021-11-04a50c72e98297…
2026-08-01 22:54:322026-06A215556-004TADALAFIL20MGTABLET / ORALAB12021-11-04a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A215556-001AB11a50c72e98297…
2026-08-01 22:54:322026-06A215556-002AB11a50c72e98297…
2026-08-01 22:54:322026-06A215556-003AB11a50c72e98297…
2026-08-01 22:54:322026-06A215556-004AB11a50c72e98297…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
tadalafilTADALAFILPD-Rx Pharmaceuticals, Inc.6c680b37-d515-4fc2-83e6-411f1017e18c2025-10-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215556
application number: ANDA215556
tadalafilTADALAFILPD-RX Pharmaceuticals, Inc.fc7596dd-42d3-af7c-e053-6294a90af01e2025-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215556
application number: ANDA215556
tadalafilTADALAFILPD-Rx Pharmaceuticals, Inc.5de70f00-00ac-4656-883e-d1e07d5f71d62025-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215556
application number: ANDA215556
tadalafilTADALAFILA-S Medication Solutionsb2d163aa-1056-47dd-85aa-297800e6c7722024-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215556
application number: ANDA215556
tadalafilTADALAFILA-S Medication Solutions00cbc656-768d-4995-bb6d-a0d4b32a248c2024-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215556
application number: ANDA215556
tadalafilTADALAFILBurel Pharmaceuticals, LLCa2e7f393-5cfc-45e5-b87d-9e8abc8e43552022-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215556
application number: ANDA215556
ndc (product): 35573-460
tadalafilTADALAFILVKT Pharma Private Limitedb4d9851c-5c06-4532-bd82-16d92b60c28f2021-11-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215556
application number: ANDA215556

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TADALAFIL2.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
742SXX0ICTInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
402019Internal RxNorm lookup
403957Internal RxNorm lookup
484814Internal RxNorm lookup
757707Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a2e7f393-5cfc-45e5-b87d-9e8abc8e4355Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b90b74cb-f6c8-3798-d11c-73b8768b278aProduct name820250317
0fe0157c-95a7-4870-ae64-de9f3fa874aeProduct name120250227
20ae0006-d78c-4dba-9e3e-6ae424841903Product name120250127
b86a08b7-54cc-440b-ad4a-3e530ccd8324Product name620230421
7a02e74a-2844-42af-84a8-96bae57351cfProduct name120230313
928d249c-35c3-4d88-a9ef-cf2f2e31b96fProduct name120220706

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35573-460-38tadalafil30 in 1 CARTONTABLET, FILM COATED304
35573-460-56tadalafil15 in 1 BLISTER PACKTABLET, FILM COATED154

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35573-460-38EA - Each35573-46081bf747e-b15f-452b-8ece-319074dab7ee12023-05-05
35573-460-56EA - Each35573-460e5c9e3df-160f-497f-8ddd-a75c60593e7512023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35573-460TADALAFIL TABLET, FILM COATED [BUREL PHARMACEUTICALS, LLC]3Current NDC, 2 package rows20230401_a2e7f393-5cfc-45e5-b87d-9e8abc8e4355.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484814tadalafil 10 MG Oral TabletPSNa2e7f393-5cfc-45e5-b87d-9e8abc8e43554
757707tadalafil 2.5 MG Oral TabletPSNa2e7f393-5cfc-45e5-b87d-9e8abc8e43554
402019tadalafil 20 MG Oral TabletPSNa2e7f393-5cfc-45e5-b87d-9e8abc8e43554
403957tadalafil 5 MG Oral TabletPSNa2e7f393-5cfc-45e5-b87d-9e8abc8e43554
484814tadalafil 10 MG Oral TabletSCDa2e7f393-5cfc-45e5-b87d-9e8abc8e43554
757707tadalafil 2.5 MG Oral TabletSCDa2e7f393-5cfc-45e5-b87d-9e8abc8e43554
402019tadalafil 20 MG Oral TabletSCDa2e7f393-5cfc-45e5-b87d-9e8abc8e43554
403957tadalafil 5 MG Oral TabletSCDa2e7f393-5cfc-45e5-b87d-9e8abc8e43554

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35573-460-383557304603830 in 1 CARTONHistorical
35573-460-563557304605615 CARTON in 1 BLISTER PACK (35573-460-56) / 30 TABLET, FILM COATED in 1 CARTON (35573-460-38) 15 carton2023-04-01NoNoCurrent