What is NDC 82804-041?

82804-041 is the product NDC for Tadalafil, Tadalafil 10 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.

Proficient Rx LP, NDC labeler code 82804. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tadalafil?

242 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tadalafil NDC 82804-041 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)82804-041Labeler and product segments. Claims need a package NDC.

Product NDC at billing width82804-0041Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
82804-041-30	8280400413082804004130	30 TABLET, FILM COATED in 1 BOTTLE (82804-041-30)Marketed from Dec 13, 2023
82804-041-60	8280400416082804004160	60 TABLET, FILM COATED in 1 BOTTLE (82804-041-60)Marketed from Dec 13, 2023
82804-041-90	8280400419082804004190	90 TABLET, FILM COATED in 1 BOTTLE (82804-041-90)Marketed from Dec 13, 2023

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Tadalafil
Generic name (nonproprietary): tadalafil
Active ingredients: Tadalafil — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Proficient Rx LPNDC labeler code 82804
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211298
Marketing start: Nov 2, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers: Product ID 82804-041_1de6acc9-9dda-4c59-bc98-c7d0562eebe4SPL ID 1de6acc9-9dda-4c59-bc98-c7d0562eebe4SPL set ID a930511d-110e-4d2e-a4ca-df712f968b2dRxCUI 484814UNII 742SXX0ICTUPC 0382804041305
Pharmacologic class: Phosphodiesterase 5 Inhibitor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N482804004130 followed by a unit qualifier and the quantity

Package 82804-0041-30. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Apr 1, 2024.

Indications (excerpt from the label)

Tadalafil tablet is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: • erectile dysfunction (ED) ( 1.1 ) • the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2 ) • ED and the signs and symptoms of BPH (ED/BPH) ( 1.3 ) If tadalafil tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks ( 1.4 ). 1.1 Erectile Dysfunction Tadalafil tablets are indicated for the treatment of erectile dysfunction (ED). 1.2 Benign Prostatic Hyperplasia Tadalafil tablets are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). 1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia Tadalafil…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 82804-041

What is NDC 82804-041?: 82804-041 is the product NDC for Tadalafil, Tadalafil 10 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tadalafil.
What is the active ingredient?: Tadalafil.
Who is the labeler?: Proficient Rx LP, NDC labeler code 82804. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tadalafil?: 242 other product NDCs are listed under this name. See all Tadalafil NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Tadalafil NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tadalafil	Tadalafil 2.5 mg/1	Tablet, Film coatedOral	NorthStar Rx, LLC	72603-781	72603-0781-01
Tadalafil	Tadalafil 5 mg/1	Tablet, Film coatedOral	NorthStar Rx, LLC	72603-782	72603-0782-01
Tadalafil	Tadalafil 10 mg/1	Tablet, Film coatedOral	NorthStar Rx, LLC	72603-783	72603-0783-01
Tadalafil	Tadalafil 20 mg/1	Tablet, Film coatedOral	NorthStar Rx, LLC	72603-784	72603-0784-01
Tadalafil	Tadalafil 5 mg/1	TabletOral	REMEDYREPACK INC.	70518-4605	70518-4605-00
tadalafil	Tadalafil 20 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4083	68788-4083-0168788-4083-0368788-4083-07
Tadalafil	Tadalafil 20 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-8039	50090-8039-0050090-8039-0150090-8039-02
Tadalafil	Tadalafil 2.5 mg/1	Tablet, Film coatedOral	Umedica Laboratories USA Inc.	60290-027	60290-0027-0160290-0027-0260290-0027-03+1 more
Tadalafil	Tadalafil 5 mg/1	Tablet, Film coatedOral	Umedica Laboratories USA Inc.	60290-028	60290-0028-0160290-0028-0260290-0028-03+1 more
Tadalafil	Tadalafil 10 mg/1	Tablet, Film coatedOral	Umedica Laboratories USA Inc.	60290-029	60290-0029-0160290-0029-0260290-0029-03+1 more

All 243 Tadalafil NDCs

Other NDCs under ANDA 211298

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 211298
Product	Strength	Form · route	Labeler	Product NDC
Tadalafil	Tadalafil 20 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-8039
Tadalafil	Tadalafil 2.5 mg/1	Tablet, Film coatedOral	Umedica Laboratories USA Inc.	60290-027
Tadalafil	Tadalafil 5 mg/1	Tablet, Film coatedOral	Umedica Laboratories USA Inc.	60290-028
Tadalafil	Tadalafil 10 mg/1	Tablet, Film coatedOral	Umedica Laboratories USA Inc.	60290-029
Tadalafil	Tadalafil 20 mg/1	Tablet, Film coatedOral	Umedica Laboratories USA Inc.	60290-030
Tadalafil	Tadalafil 2.5 mg/1	Tablet, Film coatedOral	NorthStar Rx, LLC	72603-781
Tadalafil	Tadalafil 5 mg/1	Tablet, Film coatedOral	NorthStar Rx, LLC	72603-782
Tadalafil	Tadalafil 10 mg/1	Tablet, Film coatedOral	NorthStar Rx, LLC	72603-783
Tadalafil	Tadalafil 20 mg/1	Tablet, Film coatedOral	NorthStar Rx, LLC	72603-784
Tadalafil	Tadalafil 5 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-407
Tadalafil	Tadalafil 10 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-408
Tadalafil	Tadalafil 2.5 mg/1	Tablet, Film coatedOral	NIVAGEN PHARMACEUTICALS, INC.	75834-247
Tadalafil	Tadalafil 5 mg/1	Tablet, Film coatedOral	NIVAGEN PHARMACEUTICALS, INC.	75834-248
Tadalafil	Tadalafil 10 mg/1	Tablet, Film coatedOral	NIVAGEN PHARMACEUTICALS, INC.	75834-249
Tadalafil	Tadalafil 20 mg/1	Tablet, Film coatedOral	NIVAGEN PHARMACEUTICALS, INC.	75834-250
Tadalafil	Tadalafil 5 mg/1	Tablet, Film coatedOral	Proficient Rx LP	82804-040
Tadalafil	Tadalafil 20 mg/1	Tablet, Film coatedOral	Proficient Rx LP	82804-042