NDC codes

FDA NDC Directory
Product NDC (as listed)72789-407Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72789-0407Add 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
72789-407-30727890407307278904073030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-407-30)Marketed from Jun 10, 2024
72789-407-90727890407907278904079090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-407-90)Marketed from Jun 11, 2024

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 — 5 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
PD-Rx Pharmaceuticals, Inc.NDC labeler code 72789
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211298
Marketing start
Listing expires
Other FDA classes
Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers
Product ID 72789-407_32461a60-5965-a455-e063-6294a90a3a70SPL ID 32461a60-5965-a455-e063-6294a90a3a70SPL set ID e899da81-a28e-4a7e-a0e6-ed6d557c0bcdRxCUI 403957UNII 742SXX0ICTUPC 0372789407302
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

N472789040730 followed by a unit qualifier and the quantity

Package 72789-0407-30. 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 tablet 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72789-407

What is NDC 72789-407?
72789-407 is the product NDC for Tadalafil, Tadalafil 5 mg/1 tablet, film coated, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 2 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?
PD-Rx Pharmaceuticals, Inc., NDC labeler code 72789. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TadalafilTadalafil 2.5 mg/1Tablet, Film coatedOralNorthStar Rx, LLC72603-78172603-0781-01
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralNorthStar Rx, LLC72603-78272603-0782-01
TadalafilTadalafil 10 mg/1Tablet, Film coatedOralNorthStar Rx, LLC72603-78372603-0783-01
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralNorthStar Rx, LLC72603-78472603-0784-01
TadalafilTadalafil 5 mg/1TabletOralREMEDYREPACK INC.70518-460570518-4605-00
tadalafilTadalafil 20 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-408368788-4083-0168788-4083-0368788-4083-07
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-803950090-8039-0050090-8039-0150090-8039-02
TadalafilTadalafil 2.5 mg/1Tablet, Film coatedOralUmedica Laboratories USA Inc.60290-02760290-0027-0160290-0027-0260290-0027-03+1 more
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralUmedica Laboratories USA Inc.60290-02860290-0028-0160290-0028-0260290-0028-03+1 more
TadalafilTadalafil 10 mg/1Tablet, Film coatedOralUmedica Laboratories USA Inc.60290-02960290-0029-0160290-0029-0260290-0029-03+1 more

All 243 Tadalafil NDCs

Other NDCs under ANDA 211298

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

FDA NDC Directory listings under ANDA 211298
ProductStrengthForm · routeLabelerProduct NDC
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-8039
TadalafilTadalafil 2.5 mg/1Tablet, Film coatedOralUmedica Laboratories USA Inc.60290-027
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralUmedica Laboratories USA Inc.60290-028
TadalafilTadalafil 10 mg/1Tablet, Film coatedOralUmedica Laboratories USA Inc.60290-029
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralUmedica Laboratories USA Inc.60290-030
TadalafilTadalafil 2.5 mg/1Tablet, Film coatedOralNorthStar Rx, LLC72603-781
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralNorthStar Rx, LLC72603-782
TadalafilTadalafil 10 mg/1Tablet, Film coatedOralNorthStar Rx, LLC72603-783
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralNorthStar Rx, LLC72603-784
TadalafilTadalafil 10 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-408
TadalafilTadalafil 2.5 mg/1Tablet, Film coatedOralNIVAGEN PHARMACEUTICALS, INC.75834-247
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralNIVAGEN PHARMACEUTICALS, INC.75834-248
TadalafilTadalafil 10 mg/1Tablet, Film coatedOralNIVAGEN PHARMACEUTICALS, INC.75834-249
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralNIVAGEN PHARMACEUTICALS, INC.75834-250
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralProficient Rx LP82804-040
TadalafilTadalafil 10 mg/1Tablet, Film coatedOralProficient Rx LP82804-041
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralProficient Rx LP82804-042

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