FDA.reportPublic FDA data

tadalafil

Product NDC
67296-2237
Requested package NDC
67296-2237-2
11-digit product format
672962237
Labeler code
67296
Product ID
67296-2237_52505a7a-e3de-7c4e-e063-6294a90a1473
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Redpharm Drug
Application
ANDA209250
Marketing category
ANDA
Marketing start
2019-03-26
Substance
TADALAFIL
Active strength
10 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
A209250-001TADALAFILTADALAFIL2.5MGTABLET / ORALAB12019-03-26
A209250-002TADALAFILTADALAFIL5MGTABLET / ORALAB12019-03-26
A209250-003TADALAFILTADALAFIL10MGTABLET / ORALAB12019-03-26
A209250-004TADALAFILTADALAFIL20MGTABLET / 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
A209250-001AB1
A209250-002AB1
A209250-003AB1
A209250-004AB1

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 22:54:322026-06A209250-001TADALAFIL2.5MGTABLET / ORALAB12019-03-26a50c72e98297…
2026-08-01 22:54:322026-06A209250-002TADALAFIL5MGTABLET / ORALAB12019-03-26a50c72e98297…
2026-08-01 22:54:322026-06A209250-003TADALAFIL10MGTABLET / ORALAB12019-03-26a50c72e98297…
2026-08-01 22:54:322026-06A209250-004TADALAFIL20MGTABLET / ORALAB12019-03-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209250-001AB11a50c72e98297…
2026-08-01 22:54:322026-06A209250-002AB11a50c72e98297…
2026-08-01 22:54:322026-06A209250-003AB11a50c72e98297…
2026-08-01 22:54:322026-06A209250-004AB11a50c72e98297…

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
tadalafilTADALAFILRedpharm Drug52505a7a-e3dd-7c4e-e063-6294a90a14732026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209250
application number: ANDA209250
ndc (package): 67296-2237-2
ndc (product): 67296-2237
ndc11 (package): 67296223702
tadalafilTADALAFILPreferred Pharmaceuticals Inc.fee8c2be-ccfa-4c66-abed-5e232ec762ae2026-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209250
application number: ANDA209250
tadalafilTADALAFILNuCare Pharmaceuticals,Inc.2c277890-3c5d-5fd5-e063-6394a90af15b2025-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209250
application number: ANDA209250
tadalafilTADALAFILAsclemed USA, Inc.fa547e3d-455a-4926-9fd9-3499308985022025-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209250
application number: ANDA209250
tadalafilTADALAFILProficient Rx LP7976c4ec-ecc4-4a49-a4fe-f990aece2d3c2025-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209250
application number: ANDA209250
tadalafilTADALAFILBryant Ranch Prepack24b82a6a-1b7e-42e6-b29b-41d4ee4d525f2025-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209250
application number: ANDA209250
tadalafilTADALAFILBryant Ranch Prepackff3c7dd3-2dcc-498c-a121-1e2aa62c7a972024-08-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209250
application number: ANDA209250
tadalafilTADALAFILProficient Rx LP929e391e-b74b-4ccd-8690-16ffcece7a302024-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209250
application number: ANDA209250
tadalafilTADALAFILNuCare Pharmaceuticals,Inc.13a107ba-cbbd-7760-e063-6394a90a1ee82024-03-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209250
application number: ANDA209250
tadalafilTADALAFILUnichem Pharmaceuticals (USA), Inc.a7b3937e-ff03-436a-a5d4-92a4771034b62024-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209250
application number: ANDA209250
tadalafilTADALAFILProficient Rx LPac93704f-8e33-43ba-8b56-3d61092ff1d92023-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209250
application number: ANDA209250

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TADALAFIL10 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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
52505a7a-e3dd-7c4e-e063-6294a90a1473Available 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
67296-2237-2tadalafil5 in 1 BOTTLE, PLASTICTABLET, FILM COATED51

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484814tadalafil 10 MG Oral TabletPSN52505a7a-e3dd-7c4e-e063-6294a90a14731
484814tadalafil 10 MG Oral TabletSCD52505a7a-e3dd-7c4e-e063-6294a90a14731

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67296-2237-2672962237025 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67296-2237-2) 2019-03-26NoNoCurrent