Tadalafil

Product NDC: 63629-8409
11-digit product format: 636298409
Labeler code: 63629
Product ID: 63629-8409_df1f450c-40c6-499e-af71-b3300db4f62c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tadalafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA209167
Marketing category: ANDA
Marketing start: 2019-03-27
Substance: TADALAFIL
Active strength: 2.5 mg/1
Pharmacologic classes: Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A209167-001	TADALAFIL	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26
A209167-002	TADALAFIL	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26
A209167-003	TADALAFIL	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-10-23
A209167-004	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
A209167-001	AB1
A209167-002	AB1
A209167-003	AB1
A209167-004	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.

Product history page 1 of 5 · 168 observed 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
2026-09-14 22:38:34	2026-08	A209167-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209167-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209167-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-10-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209167-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209167-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209167-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209167-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209167-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209167-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209167-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209167-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209167-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209167-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209167-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209167-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209167-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209167-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209167-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209167-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-10-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209167-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209167-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209167-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209167-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-10-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209167-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209167-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209167-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209167-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-10-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209167-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209167-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209167-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209167-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-10-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209167-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209167-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209167-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209167-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-10-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209167-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209167-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209167-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209167-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-10-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209167-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A209167-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209167-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209167-003	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209167-004	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209167-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209167-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209167-003	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209167-004	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209167-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209167-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209167-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209167-004	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209167-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209167-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209167-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209167-004	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209167-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209167-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209167-003	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209167-004	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209167-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209167-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209167-003	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209167-004	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209167-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209167-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209167-003	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209167-004	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209167-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209167-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209167-003	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209167-004	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209167-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209167-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209167-003	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209167-004	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209167-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209167-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209167-003	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209167-004	AB1	1	`5bbf6a4d5a75…`

Additional Listing Data#

Finished product: Yes
Brand name base: Tadalafil
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TADALAFIL	2.5 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
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
07567ae5-7345-4ab1-9b2c-c586c4da0427	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	SPL version
63629-8409-1	Tadalafil	90 in 1 BOTTLE	TABLET, FILM COATED	90	105
63629-8409-2	Tadalafil	30 in 1 BOTTLE	TABLET, FILM COATED	30	105
63629-8409-3	Tadalafil	10 in 1 BOTTLE	TABLET, FILM COATED	10	105
63629-8409-4	Tadalafil	20 in 1 BOTTLE	TABLET, FILM COATED	20	105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8409	TADALAFIL TABLET, FILM COATED [BRYANT RANCH PREPACK]	104	Current NDC, Legacy NDC, 4 package rows	20241109_07567ae5-7345-4ab1-9b2c-c586c4da0427.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tadalafil	TADALAFIL	A-S Medication Solutions	a6847ad6-3b5b-47e5-a3b5-04dc3182d72b	2026-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Bryant Ranch Prepack	07567ae5-7345-4ab1-9b2c-c586c4da0427	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167 ndc (product): 63629-8409
Tadalafil	TADALAFIL	Bryant Ranch Prepack	aa8d165b-0c7d-497a-b56a-7c62ebc0a5d2	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Bryant Ranch Prepack	f8def23c-55ea-4796-9735-dbcb25104835	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Accord Healthcare Inc.	eedf3ad9-7d40-496d-b1a9-6200010c18e1	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Preferred Pharmaceuticals Inc.	affacb88-4af3-4ce9-961b-7fc37b169e9a	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Northwind Health Company, LLC	f3092f5a-b976-91ab-e053-2995a90a9b50	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Northwind Health Company, LLC	f317fe1e-d7c4-fb8b-e053-2a95a90a5445	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	NuCare Pharmaceuticals,Inc.	cf35291b-b05b-1182-e053-2995a90a8dee	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	NuCare Pharmaceuticals,Inc.	9f83ea2e-8ee8-ab6d-e053-2995a90a1e96	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	NuCare Pharmaceuticals,Inc.	a0acad71-8ae3-2827-e053-2995a90a20b3	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Proficient Rx LP	7a105ef9-7129-4ce1-bd8d-ae316bf348e2	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Proficient Rx LP	b539e862-d5d4-4989-a3dd-1eba66285d53	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Proficient Rx LP	31c05a53-7282-46d0-81bd-108defe6fb38	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Proficient Rx LP	6fa9d4fa-86c9-4791-b28b-78e8b9341cea	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Asclemed USA, Inc.	aba646fe-70c2-1abb-e053-2995a90aa16d	2022-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167

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
757707	tadalafil 2.5 MG Oral Tablet	PSN	07567ae5-7345-4ab1-9b2c-c586c4da0427	105
757707	tadalafil 2.5 MG Oral Tablet	SCD	07567ae5-7345-4ab1-9b2c-c586c4da0427	105

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8409-1	63629840901	90 TABLET, FILM COATED in 1 BOTTLE (63629-8409-1)	2021-01-07	0000-00-00	No	No	Current
63629-8409-2	63629840902	30 TABLET, FILM COATED in 1 BOTTLE (63629-8409-2)	2022-06-14	0000-00-00	No	No	Current
63629-8409-3	63629840903	10 TABLET, FILM COATED in 1 BOTTLE (63629-8409-3)	2024-10-29	0000-00-00	No	No	Current
63629-8409-4	63629840904	20 TABLET, FILM COATED in 1 BOTTLE (63629-8409-4)	2024-10-29	0000-00-00	No	No	Current
63629-8409-5	63629840905	60 TABLET, FILM COATED in 1 BOTTLE (63629-8409-5)	2024-10-29		0		Current