Cialis

Product NDC: 0002-4464
11-digit product format: 000024464
Labeler code: 0002
Product ID: 0002-4464_0850d8e6-3c38-484d-990c-fd2780b46454
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tadalafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Eli Lilly and Company
Application: NDA021368
Marketing category: NDA
Marketing start: 2003-11-26
Substance: TADALAFIL
Active strength: 20 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

Orange Book products#

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021368-001	CIALIS	TADALAFIL	5MG	TABLET / ORAL	AB1	RLD	2003-11-21
N021368-002	CIALIS	TADALAFIL	10MG	TABLET / ORAL	AB1	RLD	2003-11-21
N021368-003	CIALIS	TADALAFIL	20MG	TABLET / ORAL	AB1	RLD, RS	2003-11-21
N021368-004	CIALIS	TADALAFIL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2008-01-07

Therapeutic equivalence codes#

Application-product, TE code table
Application-product	TE code
N021368-001	AB1
N021368-002	AB1
N021368-003	AB1

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cialis	TADALAFIL	Eli Lilly and Company	bcd8f8ab-81a2-4891-83db-24a0b0e25895	2026-06-03	Warnings, Adverse reactions	Exact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings and cautions

5 WARNINGS AND PRECAUTIONS Evaluation of erectile dysfunction and BPH should include an appropriate medical assessment to identify potential underlying causes, as well as treatment options. Before prescribing CIALIS, it is important to note the following: Patients should not use CIALIS if sex is inadvisable due to cardiovascular status ( 5.1 ). Use of CIALIS with alpha-blockers, antihypertensives or substantial amounts of alcohol (≥5 units) may lead to hypotension ( 5.6 , 5.9 ). CIALIS is not recommended in combination with alpha-blockers for the treatment of BPH because efficacy of the combination has not been adequately studied and because of the risk of blood pressure lowering. Caution is advised when CIALIS is used as a treatment for ED in men taking alpha-blockers. ( 2.7 , 5.6 , 7.1 , 12.2 ) Patients should seek emergency treatment if an erection lasts >4 hours. Use CIALIS with caution in patients predisposed to priapism ( 5.3 ). Patients should stop CIALIS and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION). CIALIS should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a "crowded" optic disc may also be at an increased risk of NAION ( 5.4 , 6.2 ). Patients should stop CIALIS and seek prompt medical attention in the event of sudden decrease or loss of hearing ( 5.5 ). Prior to initiating treatment with CIALIS for BPH, consideration should be given to other urological conditions that may cause similar symptoms ( 5.14 ). 5.1 Cardiovascular Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Therefore, treatments for erectile dysfunction, including CIALIS, should not be used in men for whom sexual activity is inadvisable as a result of their underlying cardiovascular status. Patients who experience symptoms upon initiation of sexual activity should be advised to refrain from further sexual activity and seek immediate medical attention. Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of CIALIS. In such a patient, who has taken CIALIS, where nitrate administration is de...

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

6 ADVERSE REACTIONS Most common adverse reactions (≥2%) include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and pain in limb ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Tadalafil was administered to over 9000 men during clinical trials worldwide. In trials of CIALIS for once daily use, a total of 1434, 905, and 115 were treated for at least 6 months, 1 year, and 2 years, respectively. For CIALIS for use as needed, over 1300 and 1000 subjects were treated for at least 6 months and 1 year, respectively. CIALIS for Use as Needed for ED In eight primary placebo-controlled clinical studies of 12 weeks duration, mean age was 59 years (range 22 to 88) and the discontinuation rate due to adverse events in patients treated with tadalafil 10 or 20 mg was 3.1%, compared to 1.4% in placebo treated patients. When taken as recommended in the placebo-controlled clinical trials, the following adverse reactions were reported ( see Table 1 ) for CIALIS for use as needed: Table 1: Treatment-Emergent Adverse Reactions Reported by ≥2% of Patients Treated with CIALIS (10 or 20 mg) and More Frequent on Drug than Placebo in the Eight Primary Placebo-Controlled Clinical Studies (Including a Study in Patients with Diabetes) for CIALIS for Use as Needed for ED a The term flushing includes: facial flushing and flushing Adverse Reaction Placebo (N=476) Tadalafil 5 mg (N=151) Tadalafil 10 mg (N=394) Tadalafil 20 mg (N=635) Headache 5% 11% 11% 15% Dyspepsia 1% 4% 8% 10% Back pain 3% 3% 5% 6% Myalgia 1% 1% 4% 3% Nasal congestion 1% 2% 3% 3% Flushing a 1% 2% 3% 3% Pain in limb 1% 1% 3% 3% CIALIS for Once Daily Use for ED In three placebo-controlled clinical trials of 12 or 24 weeks duration, mean age was 58 years (range 21 to 82) and the discontinuation rate due to adverse events in patients treated with tadalafil was 4.1%, compared to 2.8% in placebo-treated patients. The following adverse reactions were reported ( see Table 2 ) in clinical trials of 12 week...

adverse reactions table

Table 1: Treatment-Emergent Adverse Reactions Reported by ≥2% of Patients Treated with CIALIS (10 or 20 mg) and More Frequent on Drug than Placebo in the Eight Primary Placebo-Controlled Clinical Studies (Including a Study in Patients with Diabetes) for CIALIS for Use as Needed for ED a The term flushing includes: facial flushing and flushing Adverse ReactionPlacebo (N=476)Tadalafil 5 mg (N=151)Tadalafil 10 mg (N=394)Tadalafil 20 mg (N=635)Headache5% 11% 11% 15% Dyspepsia1% 4% 8% 10% Back pain3% 3% 5% 6% Myalgia1% 1% 4% 3% Nasal congestion1% 2% 3% 3% Flushinga1% 2% 3% 3% Pain in limb1% 1% 3% 3%

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TADALAFIL	20 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	742SXX0ICT
Rxcui	402019, 402096, 402097, 403957, 404711, 484814

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
0002-4464-30	Cialis	30 in 1 BOTTLE	TABLET, FILM COATED	30		51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0002-4464-30	EA - Each	0002-4464	8c511a88-2d30-416f-b66d-69e69692f661	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Tadalafil	ACTIVE INGREDIENT	742SXX0ICT	CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY]	33
Tadalafil	ACTIVE MOIETY	742SXX0ICT	CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY]	33
Cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY]	33
Croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY]	33
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY]	33
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY]	33
Hydroxypropyl cellulose (Type H)	INACTIVE INGREDIENT	RFW2ET671P	CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY]	33
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY]	33
Lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY]	33
Magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY]	33
Sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY]	33
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY]	33
Titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY]	33
Triacetin	INACTIVE INGREDIENT	XHX3C3X673	CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY]	33
Tadalafil	ACTIVE INGREDIENT	742SXX0ICT	CIALIS (TADALAFIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
Tadalafil	ACTIVE INGREDIENT	742SXX0ICT	CIALIS (TADALAFIL) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
Tadalafil	ACTIVE MOIETY	742SXX0ICT	CIALIS (TADALAFIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
Tadalafil	ACTIVE MOIETY	742SXX0ICT	CIALIS (TADALAFIL) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
Cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	CIALIS (TADALAFIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
Cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	CIALIS (TADALAFIL) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
Croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	CIALIS (TADALAFIL) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
Croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	CIALIS (TADALAFIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CIALIS (TADALAFIL) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CIALIS (TADALAFIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
Hydroxypropyl cellulose	INACTIVE INGREDIENT	RFW2ET671P	CIALIS (TADALAFIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
Hydroxypropyl cellulose	INACTIVE INGREDIENT	RFW2ET671P	CIALIS (TADALAFIL) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	CIALIS (TADALAFIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	CIALIS (TADALAFIL) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
Lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	CIALIS (TADALAFIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
Lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	CIALIS (TADALAFIL) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
Magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CIALIS (TADALAFIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
Magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CIALIS (TADALAFIL) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
Sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	CIALIS (TADALAFIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
Sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	CIALIS (TADALAFIL) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	CIALIS (TADALAFIL) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	CIALIS (TADALAFIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
Titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CIALIS (TADALAFIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
Titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CIALIS (TADALAFIL) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
Triacetin	INACTIVE INGREDIENT	XHX3C3X673	CIALIS (TADALAFIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
Triacetin	INACTIVE INGREDIENT	XHX3C3X673	CIALIS (TADALAFIL) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
Tadalafil	ACTIVE INGREDIENT	742SXX0ICT	CIALIS (TADALAFIL) TABLET, FILM COATED [CARDINAL HEALTH]	1
Tadalafil	ACTIVE INGREDIENT	742SXX0ICT	CIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
Tadalafil	ACTIVE INGREDIENT	742SXX0ICT	CIALIS (TADALAFIL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	1
Tadalafil	ACTIVE INGREDIENT	742SXX0ICT	CIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Tadalafil	ACTIVE MOIETY	742SXX0ICT	CIALIS (TADALAFIL) TABLET, FILM COATED [CARDINAL HEALTH]	1
Tadalafil	ACTIVE MOIETY	742SXX0ICT	CIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
Tadalafil	ACTIVE MOIETY	742SXX0ICT	CIALIS (TADALAFIL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	1
Tadalafil	ACTIVE MOIETY	742SXX0ICT	CIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	CIALIS (TADALAFIL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	1
Cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	CIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
Cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	CIALIS (TADALAFIL) TABLET, FILM COATED [CARDINAL HEALTH]	1
Cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	CIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	CIALIS (TADALAFIL) TABLET, FILM COATED [CARDINAL HEALTH]	1
Croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	CIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
Croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	CIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	CIALIS (TADALAFIL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CIALIS (TADALAFIL) TABLET, FILM COATED [CARDINAL HEALTH]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CIALIS (TADALAFIL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	1
Hydroxypropyl cellulose	INACTIVE INGREDIENT	RFW2ET671P	CIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Hydroxypropyl cellulose	INACTIVE INGREDIENT	RFW2ET671P	CIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
Hydroxypropyl cellulose	INACTIVE INGREDIENT	RFW2ET671P	CIALIS (TADALAFIL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	CIALIS (TADALAFIL) TABLET, FILM COATED [CARDINAL HEALTH]	1
Hypromellose	INACTIVE INGREDIENT	3NXW29V3WO	CIALIS (TADALAFIL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	1
Hypromellose	INACTIVE INGREDIENT	3NXW29V3WO	CIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	CIALIS (TADALAFIL) TABLET, FILM COATED [CARDINAL HEALTH]	1
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	CIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	CIALIS (TADALAFIL) TABLET, FILM COATED [CARDINAL HEALTH]	1
Lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	CIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
Lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	CIALIS (TADALAFIL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	1
Lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	CIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CIALIS (TADALAFIL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	1
Magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
Magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CIALIS (TADALAFIL) TABLET, FILM COATED [CARDINAL HEALTH]	1
Sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	CIALIS (TADALAFIL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	1
Sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	CIALIS (TADALAFIL) TABLET, FILM COATED [CARDINAL HEALTH]	1
Sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	CIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
Sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	CIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	CIALIS (TADALAFIL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	1
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	CIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	CIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	CIALIS (TADALAFIL) TABLET, FILM COATED [CARDINAL HEALTH]	1
Titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
Titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CIALIS (TADALAFIL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	1
Titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CIALIS (TADALAFIL) TABLET, FILM COATED [CARDINAL HEALTH]	1
Triacetin	INACTIVE INGREDIENT	XHX3C3X673	CIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
Triacetin	INACTIVE INGREDIENT	XHX3C3X673	CIALIS (TADALAFIL) TABLET, FILM COATED [CARDINAL HEALTH]	1
Triacetin	INACTIVE INGREDIENT	XHX3C3X673	CIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Triacetin	INACTIVE INGREDIENT	XHX3C3X673	CIALIS (TADALAFIL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0002-4464	CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY]	49	Current NDC, Legacy NDC, 1 package rows	20241215_bcd8f8ab-81a2-4891-83db-24a0b0e25895.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
402096	Cialis 10 MG Oral Tablet	PSN	bcd8f8ab-81a2-4891-83db-24a0b0e25895	51
402097	Cialis 20 MG Oral Tablet	PSN	bcd8f8ab-81a2-4891-83db-24a0b0e25895	51
404711	Cialis 5 MG Oral Tablet	PSN	bcd8f8ab-81a2-4891-83db-24a0b0e25895	51
484814	tadalafil 10 MG Oral Tablet	PSN	bcd8f8ab-81a2-4891-83db-24a0b0e25895	51
402019	tadalafil 20 MG Oral Tablet	PSN	bcd8f8ab-81a2-4891-83db-24a0b0e25895	51
403957	tadalafil 5 MG Oral Tablet	PSN	bcd8f8ab-81a2-4891-83db-24a0b0e25895	51
402096	tadalafil 10 MG Oral Tablet [Cialis]	SBD	bcd8f8ab-81a2-4891-83db-24a0b0e25895	51
402097	tadalafil 20 MG Oral Tablet [Cialis]	SBD	bcd8f8ab-81a2-4891-83db-24a0b0e25895	51
404711	tadalafil 5 MG Oral Tablet [Cialis]	SBD	bcd8f8ab-81a2-4891-83db-24a0b0e25895	51
484814	tadalafil 10 MG Oral Tablet	SCD	bcd8f8ab-81a2-4891-83db-24a0b0e25895	51
402019	tadalafil 20 MG Oral Tablet	SCD	bcd8f8ab-81a2-4891-83db-24a0b0e25895	51
403957	tadalafil 5 MG Oral Tablet	SCD	bcd8f8ab-81a2-4891-83db-24a0b0e25895	51
402096	Cialis 10 MG Oral Tablet	SY	bcd8f8ab-81a2-4891-83db-24a0b0e25895	51
402097	Cialis 20 MG Oral Tablet	SY	bcd8f8ab-81a2-4891-83db-24a0b0e25895	51
404711	Cialis 5 MG Oral Tablet	SY	bcd8f8ab-81a2-4891-83db-24a0b0e25895	51
402096	Cialis 10 MG Oral Tablet	PSN	ee053358-9746-4475-9d3d-ca83ea84c125	6
762660	Cialis 2.5 MG Oral Tablet	PSN	ee053358-9746-4475-9d3d-ca83ea84c125	6
402097	Cialis 20 MG Oral Tablet	PSN	ee053358-9746-4475-9d3d-ca83ea84c125	6
404711	Cialis 5 MG Oral Tablet	PSN	ee053358-9746-4475-9d3d-ca83ea84c125	6
484814	tadalafil 10 MG Oral Tablet	PSN	ee053358-9746-4475-9d3d-ca83ea84c125	6
757707	tadalafil 2.5 MG Oral Tablet	PSN	ee053358-9746-4475-9d3d-ca83ea84c125	6
402019	tadalafil 20 MG Oral Tablet	PSN	ee053358-9746-4475-9d3d-ca83ea84c125	6
403957	tadalafil 5 MG Oral Tablet	PSN	ee053358-9746-4475-9d3d-ca83ea84c125	6
402096	tadalafil 10 MG Oral Tablet [Cialis]	SBD	ee053358-9746-4475-9d3d-ca83ea84c125	6
762660	tadalafil 2.5 MG Oral Tablet [Cialis]	SBD	ee053358-9746-4475-9d3d-ca83ea84c125	6
402097	tadalafil 20 MG Oral Tablet [Cialis]	SBD	ee053358-9746-4475-9d3d-ca83ea84c125	6
404711	tadalafil 5 MG Oral Tablet [Cialis]	SBD	ee053358-9746-4475-9d3d-ca83ea84c125	6
484814	tadalafil 10 MG Oral Tablet	SCD	ee053358-9746-4475-9d3d-ca83ea84c125	6
757707	tadalafil 2.5 MG Oral Tablet	SCD	ee053358-9746-4475-9d3d-ca83ea84c125	6
402019	tadalafil 20 MG Oral Tablet	SCD	ee053358-9746-4475-9d3d-ca83ea84c125	6
403957	tadalafil 5 MG Oral Tablet	SCD	ee053358-9746-4475-9d3d-ca83ea84c125	6
402096	Cialis 10 MG Oral Tablet	SY	ee053358-9746-4475-9d3d-ca83ea84c125	6
762660	Cialis 2.5 MG Oral Tablet	SY	ee053358-9746-4475-9d3d-ca83ea84c125	6
402097	Cialis 20 MG Oral Tablet	SY	ee053358-9746-4475-9d3d-ca83ea84c125	6
404711	Cialis 5 MG Oral Tablet	SY	ee053358-9746-4475-9d3d-ca83ea84c125	6
402097	Cialis 20 MG Oral Tablet	PSN	1da40b7c-c96a-45d2-a3f2-fafad429afd6	3
402019	tadalafil 20 MG Oral Tablet	PSN	1da40b7c-c96a-45d2-a3f2-fafad429afd6	3
402097	tadalafil 20 MG Oral Tablet [Cialis]	SBD	1da40b7c-c96a-45d2-a3f2-fafad429afd6	3
402019	tadalafil 20 MG Oral Tablet	SCD	1da40b7c-c96a-45d2-a3f2-fafad429afd6	3
402097	Cialis 20 MG Oral Tablet	SY	1da40b7c-c96a-45d2-a3f2-fafad429afd6	3
402096	Cialis 10 MG Oral Tablet	PSN	0e747223-2740-4e45-9bef-ae5f7798064a	2
402097	Cialis 20 MG Oral Tablet	PSN	7178f6c0-bc15-49e1-bb65-1a8fe6f94191	2
402097	Cialis 20 MG Oral Tablet	PSN	0e747223-2740-4e45-9bef-ae5f7798064a	2
404711	Cialis 5 MG Oral Tablet	PSN	0e747223-2740-4e45-9bef-ae5f7798064a	2
484814	tadalafil 10 MG Oral Tablet	PSN	0e747223-2740-4e45-9bef-ae5f7798064a	2
402019	tadalafil 20 MG Oral Tablet	PSN	0e747223-2740-4e45-9bef-ae5f7798064a	2
402019	tadalafil 20 MG Oral Tablet	PSN	7178f6c0-bc15-49e1-bb65-1a8fe6f94191	2
403957	tadalafil 5 MG Oral Tablet	PSN	0e747223-2740-4e45-9bef-ae5f7798064a	2
402096	tadalafil 10 MG Oral Tablet [Cialis]	SBD	0e747223-2740-4e45-9bef-ae5f7798064a	2
402097	tadalafil 20 MG Oral Tablet [Cialis]	SBD	0e747223-2740-4e45-9bef-ae5f7798064a	2
402097	tadalafil 20 MG Oral Tablet [Cialis]	SBD	7178f6c0-bc15-49e1-bb65-1a8fe6f94191	2
404711	tadalafil 5 MG Oral Tablet [Cialis]	SBD	0e747223-2740-4e45-9bef-ae5f7798064a	2
484814	tadalafil 10 MG Oral Tablet	SCD	0e747223-2740-4e45-9bef-ae5f7798064a	2
402019	tadalafil 20 MG Oral Tablet	SCD	0e747223-2740-4e45-9bef-ae5f7798064a	2
402019	tadalafil 20 MG Oral Tablet	SCD	7178f6c0-bc15-49e1-bb65-1a8fe6f94191	2
403957	tadalafil 5 MG Oral Tablet	SCD	0e747223-2740-4e45-9bef-ae5f7798064a	2
402096	Cialis 10 MG Oral Tablet	SY	0e747223-2740-4e45-9bef-ae5f7798064a	2
402097	Cialis 20 MG Oral Tablet	SY	7178f6c0-bc15-49e1-bb65-1a8fe6f94191	2
402097	Cialis 20 MG Oral Tablet	SY	0e747223-2740-4e45-9bef-ae5f7798064a	2
404711	Cialis 5 MG Oral Tablet	SY	0e747223-2740-4e45-9bef-ae5f7798064a	2
402096	Cialis 10 MG Oral Tablet	PSN	ebddb745-81f9-4b25-8739-b2886032ed26	1
402097	Cialis 20 MG Oral Tablet	PSN	ebddb745-81f9-4b25-8739-b2886032ed26	1
484814	tadalafil 10 MG Oral Tablet	PSN	ebddb745-81f9-4b25-8739-b2886032ed26	1
402019	tadalafil 20 MG Oral Tablet	PSN	ebddb745-81f9-4b25-8739-b2886032ed26	1
402096	tadalafil 10 MG Oral Tablet [Cialis]	SBD	ebddb745-81f9-4b25-8739-b2886032ed26	1
402097	tadalafil 20 MG Oral Tablet [Cialis]	SBD	ebddb745-81f9-4b25-8739-b2886032ed26	1
484814	tadalafil 10 MG Oral Tablet	SCD	ebddb745-81f9-4b25-8739-b2886032ed26	1
402019	tadalafil 20 MG Oral Tablet	SCD	ebddb745-81f9-4b25-8739-b2886032ed26	1
402096	Cialis 10 MG Oral Tablet	SY	ebddb745-81f9-4b25-8739-b2886032ed26	1
402097	Cialis 20 MG Oral Tablet	SY	ebddb745-81f9-4b25-8739-b2886032ed26	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0002-4464-30	00002446430	30 TABLET, FILM COATED in 1 BOTTLE (0002-4464-30)	2003-11-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cialis	Eli Lilly and Company	2026-06-03	HUMAN PRESCRIPTION DRUG LABEL	52
Cialis	PD-Rx Pharmaceuticals, Inc.	2022-05-09	HUMAN PRESCRIPTION DRUG LABEL	48
Cialis	Bryant Ranch Prepack	2021-11-16	HUMAN PRESCRIPTION DRUG LABEL	8
Cialis	Aphena Pharma Solutions - Tennessee, LLC	2019-12-19	HUMAN PRESCRIPTION DRUG LABEL	3
Cialis	Unit Dose Services	2019-02-21	HUMAN PRESCRIPTION DRUG LABEL	6
Cialis	Cardinal Health	2019-01-02	HUMAN PRESCRIPTION DRUG LABEL	4
Cialis	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2012-09-27	HUMAN PRESCRIPTION DRUG LABEL	2
Cialis	Physicians Total Care, Inc.	2011-12-15	HUMAN PRESCRIPTION DRUG LABEL	2
Cialis	Rebel Distributors Corp.	2009-07-28	HUMAN PRESCRIPTION DRUG LABEL	1