What is NDC 68788-8445?

68788-8445 is the product NDC for Tadalafil, Tadalafil 20 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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?

241 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 68788-8445 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-8445Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-8445Add 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
68788-8445-1	68788844501	15 TABLET in 1 BOTTLE (68788-8445-1)Marketed from Aug 15, 2024
68788-8445-3	68788844503	30 TABLET in 1 BOTTLE (68788-8445-3)Marketed from May 15, 2023
68788-8445-7	68788844507	7 TABLET in 1 BOTTLE (68788-8445-7)Marketed from Aug 15, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209654
Marketing start: May 15, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers: Product ID 68788-8445_b09ea39f-b84f-4b93-bdde-ed1c4040ae4bSPL ID b09ea39f-b84f-4b93-bdde-ed1c4040ae4b
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

N468788844501 followed by a unit qualifier and the quantity

Package 68788-8445-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 68788-8445

What is NDC 68788-8445?: 68788-8445 is the product NDC for Tadalafil, Tadalafil 20 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. 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?: Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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?: 241 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 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	Tablet, Film coatedOral	NorthStar Rx, LLC	72603-782	72603-0782-01
Tadalafil	Tadalafil 2.5 mg/1	Tablet, Film coatedOral	NorthStar Rx, LLC	72603-781	72603-0781-01
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 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
Tadalafil	Tadalafil 20 mg/1	Tablet, Film coatedOral	Umedica Laboratories USA Inc.	60290-030	60290-0030-0160290-0030-0260290-0030-03+2 more

All 242 Tadalafil NDCs

Other NDCs under ANDA 209654

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

FDA NDC Directory listings under ANDA 209654
Product	Strength	Form · route	Labeler	Product NDC
Tadalafil	Tadalafil 2.5 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3540
Tadalafil	Tadalafil 10 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-184
Tadalafil	Tadalafil 20 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-2632
Tadalafil	Tadalafil 20 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-728
Tadalafil	Tadalafil 5 mg/1	TabletOral	Bryant Ranch Prepack	63629-8288
Tadalafil	Tadalafil 20 mg/1	TabletOral	Ajanta Pharma USA Inc.	27241-114
Tadalafil	Tadalafil 2.5 mg/1	TabletOral	Ajanta Pharma USA Inc.	27241-111
Tadalafil	Tadalafil 5 mg/1	TabletOral	Ajanta Pharma USA Inc.	27241-112
Tadalafil	Tadalafil 10 mg/1	TabletOral	Ajanta Pharma USA Inc.	27241-113
Tadalafil	Tadalafil 5 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-461
Tadalafil	Tadalafil 2.5 mg/1	TabletOral	Bryant Ranch Prepack	71335-1823
Tadalafil	Tadalafil 5 mg/1	TabletOral	direct rx	72189-145
Tadalafil	Tadalafil 20 mg/1	TabletOral	Bryant Ranch Prepack	71335-1491
Tadalafil	Tadalafil 20 mg/1	TabletOral	REMEDYREPACK INC.	70518-4534
Tadalafil	Tadalafil 10 mg/1	TabletOral	Asclemed USA, Inc.	76420-553
Tadalafil	Tadalafil 5 mg/1	TabletOral	Asclemed USA, Inc.	76420-551
Tadalafil	Tadalafil 2.5 mg/1	TabletOral	Asclemed USA, Inc.	76420-552
Tadalafil	Tadalafil 20 mg/1	TabletOral	Asclemed USA, Inc.	76420-554
Tadalafil	Tadalafil 5 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8292
Tadalafil	Tadalafil 5 mg/1	TabletOral	REMEDYREPACK INC.	70518-3434

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