FDA.reportPublic FDA data

Tadalafil

Product NDC
62332-180
11-digit product format
623320180
Labeler code
62332
Product ID
62332-180_76b22a5c-175e-433e-bd1e-5fefb0a78d5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tadalafil
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA204809
Marketing category
ANDA
Marketing start
2019-03-26
Substance
TADALAFIL
Active strength
20 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
A204809-001TADALAFILTADALAFIL2.5MGTABLET / ORALAB12019-03-26
A204809-002TADALAFILTADALAFIL5MGTABLET / ORALAB12019-03-26
A204809-003TADALAFILTADALAFIL10MGTABLET / ORALAB12019-03-26
A204809-004TADALAFILTADALAFIL20MGTABLET / 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
A204809-001AB1
A204809-002AB1
A204809-003AB1
A204809-004AB1

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 22:54:322026-06A204809-001TADALAFIL2.5MGTABLET / ORALAB12019-03-26a50c72e98297…
2026-08-01 22:54:322026-06A204809-002TADALAFIL5MGTABLET / ORALAB12019-03-26a50c72e98297…
2026-08-01 22:54:322026-06A204809-003TADALAFIL10MGTABLET / ORALAB12019-03-26a50c72e98297…
2026-08-01 22:54:322026-06A204809-004TADALAFIL20MGTABLET / ORALAB12019-03-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204809-001AB11a50c72e98297…
2026-08-01 22:54:322026-06A204809-002AB11a50c72e98297…
2026-08-01 22:54:322026-06A204809-003AB11a50c72e98297…
2026-08-01 22:54:322026-06A204809-004AB11a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TadalafilTADALAFILAlembic Pharmaceuticals Inc.abcb2cda-9b3f-45f6-ad5f-c2370b0dd1142025-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204809
application number: ANDA204809
ndc (product): 62332-180
TadalafilTADALAFILAlembic Pharmaceuticals Limited741102c1-8809-44d4-9098-3dc8c06047642024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204809
application number: ANDA204809

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TADALAFIL20 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
abcb2cda-9b3f-45f6-ad5f-c2370b0dd114Available 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
62332-180-30Tadalafil30 in 1 BOTTLETABLET, COATED3014
62332-180-71Tadalafil500 in 1 BOTTLETABLET, COATED50014
62332-180-91Tadalafil1000 in 1 BOTTLETABLET, COATED100014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-180-30EA - Each62332-180bcb17a4f-768b-42f7-bf43-3a7ef0a56dc512019-04-11
62332-180-91EA - Each62332-180b98872c2-f38f-4933-a59f-b7525af892ee12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-180TADALAFIL TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]14Current NDC, Legacy NDC, 3 package rows20250430_abcb2cda-9b3f-45f6-ad5f-c2370b0dd114.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484814tadalafil 10 MG Oral TabletPSNabcb2cda-9b3f-45f6-ad5f-c2370b0dd11414
757707tadalafil 2.5 MG Oral TabletPSNabcb2cda-9b3f-45f6-ad5f-c2370b0dd11414
402019tadalafil 20 MG Oral TabletPSNabcb2cda-9b3f-45f6-ad5f-c2370b0dd11414
403957tadalafil 5 MG Oral TabletPSNabcb2cda-9b3f-45f6-ad5f-c2370b0dd11414
484814tadalafil 10 MG Oral TabletSCDabcb2cda-9b3f-45f6-ad5f-c2370b0dd11414
757707tadalafil 2.5 MG Oral TabletSCDabcb2cda-9b3f-45f6-ad5f-c2370b0dd11414
402019tadalafil 20 MG Oral TabletSCDabcb2cda-9b3f-45f6-ad5f-c2370b0dd11414
403957tadalafil 5 MG Oral TabletSCDabcb2cda-9b3f-45f6-ad5f-c2370b0dd11414

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62332-180-306233201803030 TABLET, COATED in 1 BOTTLE (62332-180-30) 2019-03-260000-00-00NoNoCurrent
62332-180-7162332018071500 TABLET, COATED in 1 BOTTLE (62332-180-71) 2024-08-02NoNoCurrent
62332-180-91623320180911000 TABLET, COATED in 1 BOTTLE (62332-180-91) 2024-08-02NoNoCurrent