What is NDC 35573-461?

35573-461 is the product NDC for tadalafil, Tadalafil 5 mg/1 tablet, film coated, listed with the FDA by Burel Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Burel Pharmaceuticals, LLC, NDC labeler code 35573. 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 35573-461 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)35573-461Labeler and product segments. Claims need a package NDC.

Product NDC at billing width35573-0461Add 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	Copy
35573-461-30	3557304613035573046130	30 TABLET, FILM COATED in 1 BOTTLE (35573-461-30)Marketed from Apr 1, 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 — 5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Burel Pharmaceuticals, LLCNDC labeler code 35573
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215556
Marketing start: Apr 1, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers: Product ID 35573-461_da1eee2b-ebe6-4af3-ad52-2b349a360a9aSPL ID da1eee2b-ebe6-4af3-ad52-2b349a360a9aSPL set ID a2e7f393-5cfc-45e5-b87d-9e8abc8e4355RxCUI 402019, 403957, 484814, 757707UNII 742SXX0ICTUPC 0335573463304, 0335573462307
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

N435573046130 followed by a unit qualifier and the quantity

Package 35573-0461-30. 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 Dec 1, 2022.

Indications (excerpt from the label)

Tadalafil 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 is 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 tablets are indicated…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 35573-461

What is NDC 35573-461?: 35573-461 is the product NDC for tadalafil, Tadalafil 5 mg/1 tablet, film coated, listed with the FDA by Burel Pharmaceuticals, LLC. It has 1 package NDC, 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?: Burel Pharmaceuticals, LLC, NDC labeler code 35573. 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 215556

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

FDA NDC Directory listings under ANDA 215556
Product	Strength	Form · route	Labeler	Product NDC
tadalafil	Tadalafil 2.5 mg/1	Tablet, Film coatedOral	Burel Pharmaceuticals, LLC	35573-460
tadalafil	Tadalafil 10 mg/1	Tablet, Film coatedOral	Burel Pharmaceuticals, LLC	35573-462
tadalafil	Tadalafil 20 mg/1	Tablet, Film coatedOral	Burel Pharmaceuticals, LLC	35573-463
tadalafil	Tadalafil 5 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7314
tadalafil	Tadalafil 5 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7315
tadalafil	Tadalafil 2.5 mg/1	Tablet, Film coatedOral	VKT Pharma Private Limited	71821-006
tadalafil	Tadalafil 5 mg/1	Tablet, Film coatedOral	VKT Pharma Private Limited	71821-007
tadalafil	Tadalafil 10 mg/1	Tablet, Film coatedOral	VKT Pharma Private Limited	71821-008
tadalafil	Tadalafil 20 mg/1	Tablet, Film coatedOral	VKT Pharma Private Limited	71821-009
tadalafil	Tadalafil 5 mg/1	Tablet, Film coatedOral	PD-RX Pharmaceuticals, Inc.	72789-324
tadalafil	Tadalafil 20 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-344
tadalafil	Tadalafil 10 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-430