Tadalafil

Product NDC: 16714-075
11-digit product format: 167140075
Labeler code: 16714
Product ID: 16714-075_2b1383b3-acce-43df-9aad-2d92c439b80f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tadalafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NorthStar RxLLC
Application: ANDA208934
Marketing category: ANDA
Marketing start: 2020-02-19
Substance: TADALAFIL
Active strength: 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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A208934-001	TADALAFIL	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26
A208934-002	TADALAFIL	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26
A208934-003	TADALAFIL	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26
A208934-004	TADALAFIL	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A208934-001	AB1
A208934-002	AB1
A208934-003	AB1
A208934-004	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	A208934-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208934-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208934-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208934-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`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	A208934-001	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208934-002	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208934-003	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208934-004	AB1	1	`a50c72e98297…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tadalafil	TADALAFIL	A-S Medication Solutions	a84c1eab-5934-4e5d-8bb2-0734d6adba6a	2024-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208934 application number: ANDA208934
Tadalafil	TADALAFIL	A-S Medication Solutions	1580ab76-e229-4b8d-8c7b-82f39fecfebd	2024-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208934 application number: ANDA208934
Tadalafil	TADALAFIL	Bryant Ranch Prepack	a73b0e6f-09fc-42d6-a678-1409ce746bd1	2024-05-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208934 application number: ANDA208934
Tadalafil	TADALAFIL	Bryant Ranch Prepack	6fd94914-0c9d-4268-8ed8-3c2690707a5d	2024-04-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208934 application number: ANDA208934
Tadalafil	TADALAFIL	Bryant Ranch Prepack	a3190ceb-fb3f-45f7-a12d-4c333edaadc6	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208934 application number: ANDA208934
Tadalafil	TADALAFIL	NorthStar RxLLC	594acc15-a5bc-43b5-9659-a864b2c46eea	2023-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208934 application number: ANDA208934 ndc (product): 16714-075
Tadalafil	TADALAFIL	Sun Pharmaceutical Industries, Inc.	168a135b-1454-4def-9b03-c9a470bfcb5f	2023-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208934 application number: ANDA208934
Tadalafil	TADALAFIL	Asclemed USA, Inc.	30ae58ed-5b56-4513-8eb3-eb4f89b78f9d	2023-03-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208934 application number: ANDA208934

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TADALAFIL	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
742SXX0ICT	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
402019	Internal RxNorm lookup
403957	Internal RxNorm lookup
484814	Internal RxNorm lookup
757707	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
594acc15-a5bc-43b5-9659-a864b2c46eea	Available on FDA.report

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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16714-075-01	Tadalafil	30 in 1 BOTTLE	TABLET, FILM COATED	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-075-01	EA - Each	16714-075	638114af-8a57-44b4-bdd8-988677e1f608	1	2020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-075	TADALAFIL TABLET, FILM COATED [NORTHSTAR RXLLC]	2	Current NDC, Legacy NDC, 1 package rows	20231111_594acc15-a5bc-43b5-9659-a864b2c46eea.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
484814	tadalafil 10 MG Oral Tablet	PSN	30ae58ed-5b56-4513-8eb3-eb4f89b78f9d	2
484814	tadalafil 10 MG Oral Tablet	PSN	594acc15-a5bc-43b5-9659-a864b2c46eea	2
757707	tadalafil 2.5 MG Oral Tablet	PSN	30ae58ed-5b56-4513-8eb3-eb4f89b78f9d	2
757707	tadalafil 2.5 MG Oral Tablet	PSN	594acc15-a5bc-43b5-9659-a864b2c46eea	2
402019	tadalafil 20 MG Oral Tablet	PSN	30ae58ed-5b56-4513-8eb3-eb4f89b78f9d	2
402019	tadalafil 20 MG Oral Tablet	PSN	594acc15-a5bc-43b5-9659-a864b2c46eea	2
403957	tadalafil 5 MG Oral Tablet	PSN	a84c1eab-5934-4e5d-8bb2-0734d6adba6a	2
403957	tadalafil 5 MG Oral Tablet	PSN	30ae58ed-5b56-4513-8eb3-eb4f89b78f9d	2
403957	tadalafil 5 MG Oral Tablet	PSN	594acc15-a5bc-43b5-9659-a864b2c46eea	2
484814	tadalafil 10 MG Oral Tablet	SCD	30ae58ed-5b56-4513-8eb3-eb4f89b78f9d	2
484814	tadalafil 10 MG Oral Tablet	SCD	594acc15-a5bc-43b5-9659-a864b2c46eea	2
757707	tadalafil 2.5 MG Oral Tablet	SCD	30ae58ed-5b56-4513-8eb3-eb4f89b78f9d	2
757707	tadalafil 2.5 MG Oral Tablet	SCD	594acc15-a5bc-43b5-9659-a864b2c46eea	2
402019	tadalafil 20 MG Oral Tablet	SCD	30ae58ed-5b56-4513-8eb3-eb4f89b78f9d	2
402019	tadalafil 20 MG Oral Tablet	SCD	594acc15-a5bc-43b5-9659-a864b2c46eea	2
403957	tadalafil 5 MG Oral Tablet	SCD	a84c1eab-5934-4e5d-8bb2-0734d6adba6a	2
403957	tadalafil 5 MG Oral Tablet	SCD	594acc15-a5bc-43b5-9659-a864b2c46eea	2
403957	tadalafil 5 MG Oral Tablet	SCD	30ae58ed-5b56-4513-8eb3-eb4f89b78f9d	2
403957	tadalafil 5 MG Oral Tablet	PSN	1580ab76-e229-4b8d-8c7b-82f39fecfebd	1
403957	tadalafil 5 MG Oral Tablet	SCD	1580ab76-e229-4b8d-8c7b-82f39fecfebd	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-075-01	16714007501	30 TABLET, FILM COATED in 1 BOTTLE (16714-075-01)	2020-02-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tadalafil	A-S Medication Solutions	2024-10-24	Human Prescription Drug Label	2
Tadalafil	A-S Medication Solutions	2024-10-24	Human Prescription Drug Label	1
Tadalafil	NorthStar RxLLC \| Sun Pharmaceutical Industries Limited	2023-11-10	Human Prescription Drug Label	2
Tadalafil	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2023-03-22	HUMAN PRESCRIPTION DRUG LABEL	2