FDA.reportPublic FDA data

Tadalafil

Product NDC
69238-1347
11-digit product format
692381347
Labeler code
69238
Product ID
69238-1347_5c6a682e-8bbe-4e9c-914c-148a5a0cb2a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA209744
Marketing category
ANDA
Marketing start
2019-03-27
Substance
TADALAFIL
Active strength
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
A209744-001TADALAFILTADALAFIL2.5MGTABLET / ORALAB12019-03-26
A209744-002TADALAFILTADALAFIL5MGTABLET / ORALAB12019-03-26
A209744-003TADALAFILTADALAFIL10MGTABLET / ORALAB12019-03-26
A209744-004TADALAFILTADALAFIL20MGTABLET / ORALAB12019-03-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209744-001AB1
A209744-002AB1
A209744-003AB1
A209744-004AB1

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 22:54:322026-06A209744-001TADALAFIL2.5MGTABLET / ORALAB12019-03-26a50c72e98297…
2026-08-01 22:54:322026-06A209744-002TADALAFIL5MGTABLET / ORALAB12019-03-26a50c72e98297…
2026-08-01 22:54:322026-06A209744-003TADALAFIL10MGTABLET / ORALAB12019-03-26a50c72e98297…
2026-08-01 22:54:322026-06A209744-004TADALAFIL20MGTABLET / ORALAB12019-03-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209744-001AB11a50c72e98297…
2026-08-01 22:54:322026-06A209744-002AB11a50c72e98297…
2026-08-01 22:54:322026-06A209744-003AB11a50c72e98297…
2026-08-01 22:54:322026-06A209744-004AB11a50c72e98297…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TadalafilTADALAFILAmneal Pharmaceuticals NY LLC90f38460-62ad-492e-a3da-403d5a5a5d862026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209744
application number: ANDA209744
ndc (product): 69238-1347
TadalafilTADALAFILAvKAREb96ae7f1-7d4a-a211-e053-2995a90ab6e22026-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209744
application number: ANDA209744
TadalafilTADALAFILAphena Pharma Solutions - Tennessee, LLCbce03930-14c5-401f-ad17-06b7709983bc2025-02-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209744
application number: ANDA209744
TadalafilTADALAFILAphena Pharma Solutions - Tennessee, LLCf2e8821e-04c9-4812-8c9e-39340775cc6e2024-09-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209744
application number: ANDA209744
TadalafilTADALAFILAphena Pharma Solutions - Tennessee, LLCd1dd9d05-e9d3-49ea-aeda-047536a270372024-03-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209744
application number: ANDA209744
TadalafilTADALAFILAmneal Pharmaceuticals NY LLC2cad2167-dbd1-4df8-b407-b270487d027b2019-10-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209744
application number: ANDA209744

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TADALAFIL5 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
90f38460-62ad-492e-a3da-403d5a5a5d86Available 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
69238-1347-3Tadalafil30 in 1 BOTTLETABLET, FILM COATED308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1347-3EA - Each69238-13474d406283-1a8c-4ce8-b9ce-4ac77b6c3b6712019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1347TADALAFIL TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC]7Current NDC, Legacy NDC, 1 package rows20250312_90f38460-62ad-492e-a3da-403d5a5a5d86.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484814tadalafil 10 MG Oral TabletPSN90f38460-62ad-492e-a3da-403d5a5a5d868
757707tadalafil 2.5 MG Oral TabletPSN90f38460-62ad-492e-a3da-403d5a5a5d868
402019tadalafil 20 MG Oral TabletPSN90f38460-62ad-492e-a3da-403d5a5a5d868
403957tadalafil 5 MG Oral TabletPSN90f38460-62ad-492e-a3da-403d5a5a5d868
484814tadalafil 10 MG Oral TabletSCD90f38460-62ad-492e-a3da-403d5a5a5d868
757707tadalafil 2.5 MG Oral TabletSCD90f38460-62ad-492e-a3da-403d5a5a5d868
402019tadalafil 20 MG Oral TabletSCD90f38460-62ad-492e-a3da-403d5a5a5d868
403957tadalafil 5 MG Oral TabletSCD90f38460-62ad-492e-a3da-403d5a5a5d868

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69238-1347-36923813470330 TABLET, FILM COATED in 1 BOTTLE (69238-1347-3) 2019-03-270000-00-00NoNoCurrent