Tadalafil NDC 68382-897

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-897Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0897Add 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
68382-897-01	68382089701	100 TABLET, FILM COATED in 1 BOTTLE (68382-897-01)Marketed from Mar 27, 2019
68382-897-05	68382089705	500 TABLET, FILM COATED in 1 BOTTLE (68382-897-05)Marketed from Mar 27, 2019
68382-897-06	68382089706	30 TABLET, FILM COATED in 1 BOTTLE (68382-897-06)Marketed from Mar 27, 2019
68382-897-10	68382089710	1000 TABLET, FILM COATED in 1 BOTTLE (68382-897-10)Marketed from Mar 27, 2019
68382-897-16	68382089716	90 TABLET, FILM COATED in 1 BOTTLE (68382-897-16)Marketed from Mar 27, 2019
68382-897-50	68382089750	10 TABLET, FILM COATED in 1 BOTTLE (68382-897-50)Marketed from Mar 27, 2019
68382-897-99	68382089799	2 BLISTER PACK in 1 CARTON (68382-897-99) / 15 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Mar 27, 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 — 5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Zydus Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206693
Marketing start: Mar 27, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers: Product ID 68382-897_5a958db7-5c0e-4cf0-9227-230886cf9bf8SPL ID 5a958db7-5c0e-4cf0-9227-230886cf9bf8SPL set ID cfe43ab8-8721-4db8-8810-f0072cf8f4d3RxCUI 402019, 403957, 484814, 757707UNII 742SXX0ICT
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

N468382089701 followed by a unit qualifier and the quantity

Package 68382-0897-01. 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 Nov 8, 2023.

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 206693

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

FDA NDC Directory listings under ANDA 206693
Product	Strength	Form · route	Labeler	Product NDC
Tadalafil	Tadalafil 20 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-063
Tadalafil	Tadalafil 20 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	68382-899
Tadalafil	Tadalafil 2.5 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	68382-896
Tadalafil	Tadalafil 10 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	68382-898
Tadalafil	Tadalafil 2.5 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1475
Tadalafil	Tadalafil 5 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1476
Tadalafil	Tadalafil 10 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1477
Tadalafil	Tadalafil 20 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1478