What is NDC 68071-3545?

68071-3545 is the product NDC for Tadalafil, Tadalafil 5 mg/1 tablet, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

NuCare Pharmaceuticals,Inc., NDC labeler code 68071. 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 68071-3545 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68071-3545Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68071-3545Add 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
68071-3545-3	6807135450368071354503	30 TABLET in 1 BOTTLE (68071-3545-3)Marketed from Dec 1, 2023

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 — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: NuCare Pharmaceuticals,Inc.NDC labeler code 68071
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210609
Marketing start: Jan 18, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers: Product ID 68071-3545_2ad1be14-bc3a-7430-e063-6294a90ae0c3SPL ID 2ad1be14-bc3a-7430-e063-6294a90ae0c3SPL set ID 0b75f746-866e-3a5b-e063-6294a90a5e02RxCUI 403957UNII 742SXX0ICTUPC 0368071354539
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

N468071354503 followed by a unit qualifier and the quantity

Package 68071-3545-03. 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 Jan 3, 2025.

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 68071-3545

What is NDC 68071-3545?: 68071-3545 is the product NDC for Tadalafil, Tadalafil 5 mg/1 tablet, listed with the FDA by NuCare Pharmaceuticals,Inc.. 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?: NuCare Pharmaceuticals,Inc., NDC labeler code 68071. 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 210609

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

FDA NDC Directory listings under ANDA 210609
Product	Strength	Form · route	Labeler	Product NDC
Tadalafil	Tadalafil 20 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8664
Tadalafil	Tadalafil 20 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3753
Tadalafil	Tadalafil 10 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3758
Tadalafil	Tadalafil 20 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3781
Tadalafil	Tadalafil 2.5 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3800
Tadalafil	Tadalafil 20 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-903
Tadalafil	Tadalafil 10 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-908
Tadalafil	Tadalafil 5 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-909
Tadalafil	Tadalafil 5 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8465
Tadalafil	Tadalafil 5 mg/1	TabletOral	NuCare Pharmaceuticals,Inc..	68071-3598
Tadalafil	Tadalafil 10 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3601
Tadalafil	Tadalafil 20 mg/1	TabletOral	A-S Medication Solutions	50090-7152
Tadalafil	Tadalafil 2.5 mg/1	TabletOral	Solco Healthcare US, LLC	43547-030
Tadalafil	Tadalafil 5 mg/1	TabletOral	Solco Healthcare US, LLC	43547-031
Tadalafil	Tadalafil 10 mg/1	TabletOral	Solco Healthcare US, LLC	43547-032
Tadalafil	Tadalafil 20 mg/1	TabletOral	Solco Healthcare US, LLC	43547-033
Tadalafil	Tadalafil 2.5 mg/1	TabletOral	Solco Healthcare US, LLC	43547-047
Tadalafil	Tadalafil 5 mg/1	TabletOral	Solco Healthcare US, LLC	43547-049
Tadalafil	Tadalafil 10 mg/1	TabletOral	Solco Healthcare US, LLC	43547-050
Tadalafil	Tadalafil 20 mg/1	TabletOral	Solco Healthcare US, LLC	43547-051

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