Tadalafil NDC 13668-568

NDC codes

FDA NDC Directory

Product NDC (as listed)13668-568Labeler and product segments. Claims need a package NDC.

Product NDC at billing width13668-0568Add 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
13668-568-05	13668056805	500 TABLET in 1 BOTTLE (13668-568-05)Marketed from Mar 26, 2019
13668-568-30	13668056830	30 TABLET in 1 BOTTLE (13668-568-30)Marketed from Mar 26, 2019

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 — 20 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Torrent Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211839
Marketing start: Mar 26, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers: Product ID 13668-568_8d94d098-d4f5-488c-8cc9-d21f32b727ecSPL ID 8d94d098-d4f5-488c-8cc9-d21f32b727ecSPL set ID 3ea7612b-b004-43ef-accc-34c8ec5146b8RxCUI 402019, 403957, 484814, 757707UNII 742SXX0ICTUPC 0313668565300, 0313668566307, 0313668568301, 0313668567304
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

N413668056805 followed by a unit qualifier and the quantity

Package 13668-0568-05. 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 Mar 5, 2026.

Indications (excerpt from the label)

Tadalafil tablets are 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 tab…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211839

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

FDA NDC Directory listings under ANDA 211839
Product	Strength	Form · route	Labeler	Product NDC
Tadalafil	Tadalafil 5 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-4018
Tadalafil	Tadalafil 2.5 mg/1	TabletOral	Torrent Pharmaceuticals Limited	13668-565
Tadalafil	Tadalafil 5 mg/1	TabletOral	Torrent Pharmaceuticals Limited	13668-566
Tadalafil	Tadalafil 10 mg/1	TabletOral	Torrent Pharmaceuticals Limited	13668-567
Tadalafil	Tadalafil 5 mg/1	TabletOral	REMEDYREPACK INC.	70518-4605
Tadalafil	Tadalafil 5 mg/1	TabletOral	Asclemed USA, Inc.	76420-546