TADLIQ

Product NDC: 46287-045
11-digit product format: 462870045
Labeler code: 46287
Product ID: 46287-045_cf6ec62b-5d5e-49ed-8d46-8a759d0e2b93
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tadalafil
Dosage form: SUSPENSION
Route: ORAL
Labeler: CMP Pharma, Inc.
Application: NDA214522
Marketing category: NDA
Marketing start: 2022-08-30
Substance: TADALAFIL
Active strength: 20 mg/5mL
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 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N214522-001	TADLIQ	TADALAFIL	20MG/5ML	SUSPENSION / ORAL		RLD, RS	2022-06-17

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214522-001	11382917	2038-12-24	U-3397	Drug product	2022-07-13
N214522-001	11666576	2038-12-24	U-3397	Drug product	2023-06-15
N214522-001	11975006	2038-12-24	U-3397	Drug product	2024-05-16
N214522-001	12186322	2038-12-24	U-3397	Drug product	2025-01-10
N214522-001	12691120	2038-12-24	U-3397	Drug product	2026-07-28
N214522-001	12697338	2038-12-24	U-3397	Drug product	2026-08-04

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N214522-001	11382917	2038-12-24	U-3397	Drug product	2022-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214522-001	11666576	2038-12-24	U-3397	Drug product	2023-06-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214522-001	11975006	2038-12-24	U-3397	Drug product	2024-05-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214522-001	12186322	2038-12-24	U-3397	Drug product	2025-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214522-001	12691120	2038-12-24	U-3397	Drug product	2026-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214522-001	12697338	2038-12-24	U-3397	Drug product	2026-08-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214522-001	11382917	2038-12-24	U-3397	Drug product	2022-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214522-001	11666576	2038-12-24	U-3397	Drug product	2023-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214522-001	11975006	2038-12-24	U-3397	Drug product	2024-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214522-001	12186322	2038-12-24	U-3397	Drug product	2025-01-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214522-001	11382917	2038-12-24	U-3397	Drug product	2022-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214522-001	11666576	2038-12-24	U-3397	Drug product	2023-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214522-001	11975006	2038-12-24	U-3397	Drug product	2024-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214522-001	12186322	2038-12-24	U-3397	Drug product	2025-01-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214522-001	11382917	2038-12-24	U-3397	Drug product	2022-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214522-001	11666576	2038-12-24	U-3397	Drug product	2023-06-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214522-001	11975006	2038-12-24	U-3397	Drug product	2024-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214522-001	12186322	2038-12-24	U-3397	Drug product	2025-01-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214522-001	11382917	2038-12-24	U-3397	Drug product	2022-07-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214522-001	11666576	2038-12-24	U-3397	Drug product	2023-06-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214522-001	11975006	2038-12-24	U-3397	Drug product	2024-05-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214522-001	12186322	2038-12-24	U-3397	Drug product	2025-01-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214522-001	11382917	2038-12-24	U-3397	Drug product	2022-07-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214522-001	11666576	2038-12-24	U-3397	Drug product	2023-06-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214522-001	11975006	2038-12-24	U-3397	Drug product	2024-05-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214522-001	12186322	2038-12-24	U-3397	Drug product	2025-01-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214522-001	11382917	2038-12-24	U-3397	Drug product	2022-07-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214522-001	11666576	2038-12-24	U-3397	Drug product	2023-06-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214522-001	11975006	2038-12-24	U-3397	Drug product	2024-05-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214522-001	11382917	2038-12-24	U-3397	Drug product	2022-07-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214522-001	11666576	2038-12-24	U-3397	Drug product	2023-06-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214522-001	11975006	2038-12-24	U-3397	Drug product	2024-05-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214522-001	11382917	2038-12-24	U-3397	Drug product	2022-07-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214522-001	11666576	2038-12-24	U-3397	Drug product	2023-06-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214522-001	11975006	2038-12-24	U-3397	Drug product	2024-05-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214522-001	11382917	2038-12-24	U-3397	Drug product	2022-07-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214522-001	11666576	2038-12-24	U-3397	Drug product	2023-06-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214522-001	11975006	2038-12-24	U-3397	Drug product	2024-05-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214522-001	11382917	2038-12-24	U-3397	Drug product	2022-07-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214522-001	11666576	2038-12-24	U-3397	Drug product	2023-06-15	`d06236e962d9…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TADALAFIL	20 mg/5mL

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2613563	Internal RxNorm lookup
2613569	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
7a909b25-3772-403e-a5fe-e4a040293fb7	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	Strength	SPL version
46287-045-15	TADLIQ	150 mL in 1 BOTTLE	SUSPENSION	150		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
46287-045-15	ML - Milliliter	46287-045	bd68cb69-b53f-4d56-b8c7-0edb5216a1da	1	2022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46287-045	TADLIQ (TADALAFIL) SUSPENSION [CMP PHARMA, INC.]	5	Current NDC, Legacy NDC, 1 package rows	20231023_7a909b25-3772-403e-a5fe-e4a040293fb7.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TADLIQ	TADALAFIL	CMP Pharma, Inc.	7a909b25-3772-403e-a5fe-e4a040293fb7	2022-10-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214522 application number: NDA214522 ndc (product): 46287-045

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
2613563	tadalafil 20 MG in 5 mL Oral Suspension	PSN	7a909b25-3772-403e-a5fe-e4a040293fb7	6
2613569	tadliq 20 MG in 5 mL Oral Suspension	PSN	7a909b25-3772-403e-a5fe-e4a040293fb7	6
2613569	tadalafil 4 MG/ML Oral Suspension [Tadliq]	SBD	7a909b25-3772-403e-a5fe-e4a040293fb7	6
2613563	tadalafil 4 MG/ML Oral Suspension	SCD	7a909b25-3772-403e-a5fe-e4a040293fb7	6
2613563	tadalafil 20 MG per 5 mL Oral Suspension	SY	7a909b25-3772-403e-a5fe-e4a040293fb7	6
2613569	Tadliq 20 MG per 5 mL Oral Suspension	SY	7a909b25-3772-403e-a5fe-e4a040293fb7	6
2613569	Tadliq 4 MG/ML Oral Suspension	SY	7a909b25-3772-403e-a5fe-e4a040293fb7	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
46287-045-15	46287004515	150 mL in 1 BOTTLE (46287-045-15)	150 ml	2022-08-30	0000-00-00	No	No	Current