NDC codes

FDA NDC Directory
Product NDC (as listed)72303-0822Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72303-0822Add 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
72303-0822-17230308220130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72303-0822-1)Marketed from Mar 27, 2019

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
Tadalafil2.5 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211335
Marketing start
Listing expires
Other FDA classes
Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers
Product ID 72303-0822_4c53221b-7a21-9531-e063-6294a90a9ac4SPL ID 4c53221b-7a21-9531-e063-6294a90a9ac4SPL set ID a0f728b6-2cc6-cb65-e053-2a95a90ab142RxCUI 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

N472303082201 followed by a unit qualifier and the quantity

Package 72303-0822-01. 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 .

Indications (excerpt from the label)

Tadalafil tablets, USP are 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, USP 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, USP are indicated for the treatment of erectile dysfunction (ED). 1.2 Benign Prostatic Hyperplasia Tadalafil tablets, USP are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). 1.3 Erectile Dysfunction and Benign Prostatic Hyperpl

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211335

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

FDA NDC Directory listings under ANDA 211335
ProductStrengthForm · routeLabelerProduct NDC
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralHEC Pharm USA Inc.72303-0825
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralHEC Pharm USA Inc.72303-0823
TadalafilTadalafil 10 mg/1Tablet, Film coatedOralHEC Pharm USA Inc.72303-0824

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