NDC codes

FDA NDC Directory
Product NDC (as listed)16729-369Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16729-0369Add 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 NDC11-digit (billing)PackageCopy
16729-369-101672903691030 TABLET, FILM COATED in 1 BOTTLE (16729-369-10)Marketed from Mar 27, 2019
16729-369-1616729036916500 TABLET, FILM COATED in 1 BOTTLE (16729-369-16)Marketed from May 5, 2020

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 — 2.5 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209167
Marketing start
Listing expires
Other FDA classes
Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers
Product ID 16729-369_4f99c59f-9b38-f54a-e063-6294a90a60eeSPL ID 4f99c59f-9b38-f54a-e063-6294a90a60eeSPL set ID eedf3ad9-7d40-496d-b1a9-6200010c18e1RxCUI 402019, 403957, 484814, 757707UNII 742SXX0ICTUPC 0316729372107, 0316729369107, 0316729370103
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

N416729036910 followed by a unit qualifier and the quantity

Package 16729-0369-10. 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 .

Indications (excerpt from the label)

Tadalafil is 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 tablets are …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209167

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

FDA NDC Directory listings under ANDA 209167
ProductStrengthForm · routeLabelerProduct NDC
TadalafilTadalafil 2.5 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-8409
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-473
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-487
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8153
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralAccord Healthcare Inc.16729-370
TadalafilTadalafil 10 mg/1Tablet, Film coatedOralAccord Healthcare Inc.16729-371
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralAccord Healthcare Inc.16729-372
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-5186
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-5202
TadalafilTadalafil 10 mg/1Tablet, Film coatedOralProficient Rx LP71205-720
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1587
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6150
TadalafilTadalafil 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1620
TadalafilTadalafil 10 mg/1Tablet, Film coatedOralProficient Rx LP71205-502
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-2553
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-126
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralProficient Rx LP71205-268
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralProficient Rx LP71205-269

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