NDC codes

FDA NDC Directory
Product NDC (as listed)50090-7315Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-7315Add 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
50090-7315-0500907315005009073150090 TABLET, FILM COATED in 1 BOTTLE (50090-7315-0)Marketed from Oct 14, 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 — 5 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
A-S Medication SolutionsNDC labeler code 50090
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215556
Marketing start
Listing expires
Other FDA classes
Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers
Product ID 50090-7315_e7caaf8f-10ff-4637-82e0-d152f4029bceSPL ID e7caaf8f-10ff-4637-82e0-d152f4029bceSPL set ID 00cbc656-768d-4995-bb6d-a0d4b32a248cRxCUI 403957UNII 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

N450090731500 followed by a unit qualifier and the quantity

Package 50090-7315-00. 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 is 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 indicated…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50090-7315

What is NDC 50090-7315?
50090-7315 is the product NDC for tadalafil, Tadalafil 5 mg/1 tablet, film coated, listed with the FDA by A-S Medication Solutions. 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?
A-S Medication Solutions, NDC labeler code 50090. 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 215556

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

FDA NDC Directory listings under ANDA 215556
ProductStrengthForm · routeLabelerProduct NDC
tadalafilTadalafil 2.5 mg/1Tablet, Film coatedOralBurel Pharmaceuticals, LLC35573-460
tadalafilTadalafil 5 mg/1Tablet, Film coatedOralBurel Pharmaceuticals, LLC35573-461
tadalafilTadalafil 10 mg/1Tablet, Film coatedOralBurel Pharmaceuticals, LLC35573-462
tadalafilTadalafil 20 mg/1Tablet, Film coatedOralBurel Pharmaceuticals, LLC35573-463
tadalafilTadalafil 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7314
tadalafilTadalafil 2.5 mg/1Tablet, Film coatedOralVKT Pharma Private Limited71821-006
tadalafilTadalafil 5 mg/1Tablet, Film coatedOralVKT Pharma Private Limited71821-007
tadalafilTadalafil 10 mg/1Tablet, Film coatedOralVKT Pharma Private Limited71821-008
tadalafilTadalafil 20 mg/1Tablet, Film coatedOralVKT Pharma Private Limited71821-009
tadalafilTadalafil 5 mg/1Tablet, Film coatedOralPD-RX Pharmaceuticals, Inc.72789-324
tadalafilTadalafil 20 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-344
tadalafilTadalafil 10 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-430

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