Home NDC 0093-3016-65 Tadalafil
Product NDC 0093-3016
Requested package NDC 0093-3016-65
11-digit product format 000933016
Labeler code 0093
Product ID 0093-3016_08e8069b-c417-4cb8-8423-ffc540232a6a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tadalafil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA090141
Marketing category ANDA
Marketing start 2018-09-27
Marketing end 0000-00-00
Substance TADALAFIL
Active strength 3 mg/1
Pharmacologic classes Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090141-001 TADALAFIL TADALAFIL 2.5MG TABLET / ORAL AB1 2018-05-22 A090141-002 TADALAFIL TADALAFIL 5MG TABLET / ORAL AB1 2018-05-22 A090141-003 TADALAFIL TADALAFIL 10MG TABLET / ORAL AB1 2018-05-22 A090141-004 TADALAFIL TADALAFIL 20MG TABLET / ORAL AB1 2018-05-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A090141-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2018-05-22 a50c72e98297…2026-08-01 22:54:32 2026-06 A090141-002 TADALAFIL 5MG TABLET / ORAL AB1 2018-05-22 a50c72e98297…2026-08-01 22:54:32 2026-06 A090141-003 TADALAFIL 10MG TABLET / ORAL AB1 2018-05-22 a50c72e98297…2026-08-01 22:54:32 2026-06 A090141-004 TADALAFIL 20MG TABLET / ORAL AB1 2018-05-22 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product No
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TADALAFIL 2.5 mg/1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-3016 TADALAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] 16 Legacy NDC 20241211_247ec8fe-e44c-4341-b992-2d6fd6d5f2ba.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0093-3016-65 00093301665 2 BLISTER PACK in 1 BOX (0093-3016-65) > 15 TABLET, FILM COATED in 1 BLISTER PACK (0093-3016-30) 2 blister pack 2018-09-27 0000-00-00 No No Current