What is NDC 68382-899?

68382-899 is the product NDC for Tadalafil, Tadalafil 20 mg/1 tablet, film coated, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 6 package NDCs, shown above in 10- and 11-digit form.

Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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 68382-899 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-899Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0899Add 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
68382-899-01	6838208990168382089901	100 TABLET, FILM COATED in 1 BOTTLE (68382-899-01)Marketed from Mar 27, 2019
68382-899-05	6838208990568382089905	500 TABLET, FILM COATED in 1 BOTTLE (68382-899-05)Marketed from Mar 27, 2019
68382-899-06	6838208990668382089906	30 TABLET, FILM COATED in 1 BOTTLE (68382-899-06)Marketed from Mar 27, 2019
68382-899-10	6838208991068382089910	1000 TABLET, FILM COATED in 1 BOTTLE (68382-899-10)Marketed from Mar 27, 2019
68382-899-16	6838208991668382089916	90 TABLET, FILM COATED in 1 BOTTLE (68382-899-16)Marketed from Mar 27, 2019
68382-899-99	6838208999968382089999	2 BLISTER PACK in 1 CARTON (68382-899-99) / 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 — 20 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Zydus Pharmaceuticals USA Inc.NDC labeler code 68382
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206693
Marketing start: Mar 27, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers: Product ID 68382-899_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

N468382089901 followed by a unit qualifier and the quantity

Package 68382-0899-01. 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)

About NDC 68382-899

What is NDC 68382-899?: 68382-899 is the product NDC for Tadalafil, Tadalafil 20 mg/1 tablet, film coated, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 6 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?: Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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 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 2.5 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	68382-896
Tadalafil	Tadalafil 5 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	68382-897
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