FDA.reportPublic FDA data

Tadalafil

Product NDC
43598-576
11-digit product format
435980576
Labeler code
43598
Product ID
43598-576_7d8af9db-e459-1195-41b8-67f96e390ef2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr.Reddys Laboratories Inc
Application
ANDA210069
Marketing category
ANDA
Marketing start
2019-03-26
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
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210069-001TADALAFILTADALAFIL2.5MGTABLET / ORALAB12019-03-26
A210069-002TADALAFILTADALAFIL5MGTABLET / ORALAB12019-03-26
A210069-003TADALAFILTADALAFIL10MGTABLET / ORALAB12019-03-26
A210069-004TADALAFILTADALAFIL20MGTABLET / 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
A210069-001AB1
A210069-002AB1
A210069-003AB1
A210069-004AB1

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 22:54:322026-06A210069-001TADALAFIL2.5MGTABLET / ORALAB12019-03-26a50c72e98297…
2026-08-01 22:54:322026-06A210069-002TADALAFIL5MGTABLET / ORALAB12019-03-26a50c72e98297…
2026-08-01 22:54:322026-06A210069-003TADALAFIL10MGTABLET / ORALAB12019-03-26a50c72e98297…
2026-08-01 22:54:322026-06A210069-004TADALAFIL20MGTABLET / ORALAB12019-03-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A210069-001AB11a50c72e98297…
2026-08-01 22:54:322026-06A210069-002AB11a50c72e98297…
2026-08-01 22:54:322026-06A210069-003AB11a50c72e98297…
2026-08-01 22:54:322026-06A210069-004AB11a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TadalafilTADALAFILDr.Reddys Laboratories Inc22b8a2e3-d1b8-f193-45fa-77cc62a1b9412020-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210069
application number: ANDA210069
ndc (product): 43598-576

Additional Listing Data#

Finished product
Yes
Brand name base
Tadalafil
Listing expiration
2026-12-31

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
22b8a2e3-d1b8-f193-45fa-77cc62a1b941Available 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
43598-576-30Tadalafil30 in 1 BOTTLETABLET, FILM COATED308
43598-576-31Tadalafil3 in 1 CARTONTABLET, FILM COATED38
43598-576-79Tadalafil10 in 1 BLISTER PACKTABLET, FILM COATED108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-576-30EA - Each43598-5766c8df8d2-709b-45eb-afc5-876ada092bfe12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-576TADALAFIL TABLET, FILM COATED [DR.REDDYS LABORATORIES INC]8Current NDC, Legacy NDC, 3 package rows20211130_22b8a2e3-d1b8-f193-45fa-77cc62a1b941.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484814tadalafil 10 MG Oral TabletPSN22b8a2e3-d1b8-f193-45fa-77cc62a1b9418
757707tadalafil 2.5 MG Oral TabletPSN22b8a2e3-d1b8-f193-45fa-77cc62a1b9418
402019tadalafil 20 MG Oral TabletPSN22b8a2e3-d1b8-f193-45fa-77cc62a1b9418
403957tadalafil 5 MG Oral TabletPSN22b8a2e3-d1b8-f193-45fa-77cc62a1b9418
484814tadalafil 10 MG Oral TabletSCD22b8a2e3-d1b8-f193-45fa-77cc62a1b9418
757707tadalafil 2.5 MG Oral TabletSCD22b8a2e3-d1b8-f193-45fa-77cc62a1b9418
402019tadalafil 20 MG Oral TabletSCD22b8a2e3-d1b8-f193-45fa-77cc62a1b9418
403957tadalafil 5 MG Oral TabletSCD22b8a2e3-d1b8-f193-45fa-77cc62a1b9418

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-576-304359805763030 TABLET, FILM COATED in 1 BOTTLE (43598-576-30) 2019-03-260000-00-00NoNoCurrent
43598-576-31435980576313 BLISTER PACK in 1 CARTON (43598-576-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK (43598-576-79) 3 blister pack2020-04-070000-00-00NoNoCurrent
43598-576-794359805767910 in 1 BLISTER PACKHistorical