Tadalafil

Product NDC: 63629-8288
11-digit product format: 636298288
Labeler code: 63629
Product ID: 63629-8288_08531412-01c1-4053-93b6-83f785a873cd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tadalafil
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA209654
Marketing category: ANDA
Marketing start: 2019-03-26
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
A209654-001	TADALAFIL	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26
A209654-002	TADALAFIL	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26
A209654-003	TADALAFIL	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26
A209654-004	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
A209654-001	AB1
A209654-002	AB1
A209654-003	AB1
A209654-004	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	A209654-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209654-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209654-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209654-004	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	A209654-001	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209654-002	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209654-003	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209654-004	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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tadalafil	TADALAFIL	REMEDYREPACK INC.	415bd983-86f3-4f38-917a-9805024f31cb	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	REMEDYREPACK INC.	ad288e9d-020a-43a0-9c07-320c5c3bbc1e	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Bryant Ranch Prepack	2c2ec257-06bc-4ca4-9cf3-d0f49980e374	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Bryant Ranch Prepack	c835a34a-9bae-4d88-b951-1b78ab92f388	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	PD-Rx Pharmaceuticals, Inc.	f34e4747-28be-4ae5-ac9a-a825083b6a9b	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	PD-Rx Pharmaceuticals, Inc.	7e236f83-14bf-4862-91fb-74d766aef6a9	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	NuCare Pharmaceuticals,Inc.	cf353da9-31c6-66c2-e053-2995a90a3bb0	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Quallent Pharmaceuticals Health LLC	dc14daa3-cae9-4751-9034-b0e9c18054b4	2025-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Ajanta Pharma USA Inc.	7e4cdac1-42cc-4038-a86b-4890962ed806	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Preferred Pharmaceuticals Inc.	2354c3e2-7b5f-4fdd-bbf2-7fa3c57686f8	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Preferred Pharmaceuticals Inc.	761dc0f8-2f65-4615-ab49-a4bcffd40ce9	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
TADALAFIL	TADALAFIL	direct rx	b3ee8325-bcb2-43fd-e053-2a95a90a08c8	2025-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	NuCare Pharmaceuticals,Inc.	0a9cf85a-c17d-6890-e063-6394a90a93e9	2025-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Bryant Ranch Prepack	85ed0cbc-df84-44df-a9eb-f9587dbc21df	2024-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Bryant Ranch Prepack	185a3284-3a4f-44d3-9278-98581d33f95b	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654 ndc (product): 63629-8288
Tadalafil	TADALAFIL	A-S Medication Solutions	b1840f16-a7ea-44bd-b091-5268990aedb2	2024-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Aphena Pharma Solutions - Tennessee, LLC	6213fd38-9580-4253-91d2-14c28a711c20	2023-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Asclemed USA, Inc.	5ea24573-2d16-40d8-a46c-7b5fa8669e69	2023-03-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Proficient Rx LP	aa345972-40b4-415e-acb5-31b808a8d815	2023-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Aphena Pharma Solutions - Tennessee, LLC	36350106-98bc-41fc-bede-8be5e6f54a8a	2020-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
403957	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
185a3284-3a4f-44d3-9278-98581d33f95b	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
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	SPL version
63629-8288-1	Tadalafil	30 in 1 BOTTLE	TABLET	30	108
63629-8288-2	Tadalafil	90 in 1 BOTTLE	TABLET	90	108
63629-8288-3	Tadalafil	15 in 1 BOTTLE	TABLET	15	108
63629-8288-4	Tadalafil	60 in 1 BOTTLE	TABLET	60	108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-8288-2	EA - Each	63629-8288	382bfc8d-9544-4b8a-a3fe-eca18f748c68	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8288	TADALAFIL TABLET [BRYANT RANCH PREPACK]	108	Current NDC, Legacy NDC, 4 package rows	20240809_185a3284-3a4f-44d3-9278-98581d33f95b.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
403957	tadalafil 5 MG Oral Tablet	PSN	185a3284-3a4f-44d3-9278-98581d33f95b	108
403957	tadalafil 5 MG Oral Tablet	SCD	185a3284-3a4f-44d3-9278-98581d33f95b	108

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8288-1	63629828801	30 TABLET in 1 BOTTLE (63629-8288-1)	30 tablet	2022-06-13	0000-00-00	No	No	Current
63629-8288-2	63629828802	90 TABLET in 1 BOTTLE (63629-8288-2)	90 tablet	2023-03-10	0000-00-00	No	No	Current
63629-8288-3	63629828803	15 TABLET in 1 BOTTLE (63629-8288-3)	15 tablet	2021-02-22		No	No	Current
63629-8288-4	63629828804	60 TABLET in 1 BOTTLE (63629-8288-4)	60 tablet	2021-02-22		No	No	Current