Tadalafil

Product NDC: 71205-418
11-digit product format: 712050418
Labeler code: 71205
Product ID: 71205-418_d16b3ad6-7c3f-4379-b179-b5b6dab29a58
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tadalafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA090141
Marketing category: ANDA
Marketing start: 2018-09-27
Marketing end: 0000-00-00
Substance: TADALAFIL
Active strength: 10 mg/1
Pharmacologic classes: Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71205-418		D	Discontinued by firm	2026-07-31
excluded package	package	71205-418	71205-418-30	D	Discontinued by firm	2026-07-31
excluded package	package	71205-418	71205-418-60	D	Discontinued by firm	2026-07-31
excluded package	package	71205-418	71205-418-90	D	Discontinued by firm	2026-07-31

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	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.

Application-product, TE code table
Application-product	TE code
A090141-001	AB1
A090141-002	AB1
A090141-003	AB1
A090141-004	AB1

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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A090141-001	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090141-002	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090141-003	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090141-004	AB1	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b90b74cb-f6c8-3798-d11c-73b8768b278a	Product name	8	20250317
0fe0157c-95a7-4870-ae64-de9f3fa874ae	Product name	1	20250227
20ae0006-d78c-4dba-9e3e-6ae424841903	Product name	1	20250127
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
b86a08b7-54cc-440b-ad4a-3e530ccd8324	Product name	6	20230421
7a02e74a-2844-42af-84a8-96bae57351cf	Product name	1	20230313
928d249c-35c3-4d88-a9ef-cf2f2e31b96f	Product name	1	20220706
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-418-30	EA - Each	71205-418	4130e6b5-0999-43e8-b06b-111fb2120751	1	2020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-418	TADALAFIL TABLET, FILM COATED [PROFICIENT RX LP]	1	Legacy NDC	20200320_d16b3ad6-7c3f-4379-b179-b5b6dab29a58.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
742SXX0ICT	TADALAFIL	171596-29-5	TADALAFIL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-418-30	71205041830	30 TABLET, FILM COATED in 1 BOTTLE (71205-418-30)	2020-03-04	0000-00-00	No	No	Current
71205-418-60	71205041860	60 TABLET, FILM COATED in 1 BOTTLE (71205-418-60)	2020-03-04	0000-00-00	No	No	Current
71205-418-90	71205041890	90 TABLET, FILM COATED in 1 BOTTLE (71205-418-90)	2020-03-04	0000-00-00	No	No	Current