NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1255Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1255Add 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
71335-1255-1713351255017133512550130 TABLET, FILM COATED in 1 BOTTLE (71335-1255-1)Marketed from Jun 20, 2019
71335-1255-2713351255027133512550210 TABLET, FILM COATED in 1 BOTTLE (71335-1255-2)Marketed from Jun 21, 2019
71335-1255-3713351255037133512550390 TABLET, FILM COATED in 1 BOTTLE (71335-1255-3)Marketed from May 17, 2024
71335-1255-471335125504713351255045 TABLET, FILM COATED in 1 BOTTLE (71335-1255-4)Marketed from May 17, 2024
71335-1255-5713351255057133512550560 TABLET, FILM COATED in 1 BOTTLE (71335-1255-5)Marketed from May 17, 2024
71335-1255-6713351255067133512550620 TABLET, FILM COATED in 1 BOTTLE (71335-1255-6)Marketed from May 17, 2024
71335-1255-7713351255077133512550715 TABLET, FILM COATED in 1 BOTTLE (71335-1255-7)Marketed from May 17, 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 — 20 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208934
Marketing start
Listing expires
Other FDA classes
Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers
Product ID 71335-1255_169c8d84-94fd-4024-b98e-a7184dbe83b1SPL ID 169c8d84-94fd-4024-b98e-a7184dbe83b1SPL set ID a73b0e6f-09fc-42d6-a678-1409ce746bd1RxCUI 402019UNII 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

N471335125501 followed by a unit qualifier and the quantity

Package 71335-1255-01. 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 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 indicate…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-1255

What is NDC 71335-1255?
71335-1255 is the product NDC for Tadalafil, Tadalafil 20 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 7 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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 208934

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

FDA NDC Directory listings under ANDA 208934
ProductStrengthForm · routeLabelerProduct NDC
TadalafilTadalafil 2.5 mg/1Tablet, Film coatedOralNorthStar RxLLC16714-074
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralNorthStar RxLLC16714-075
TadalafilTadalafil 10 mg/1Tablet, Film coatedOralNorthStar RxLLC16714-076
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralNorthStar RxLLC16714-077
TadalafilTadalafil 2.5 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.47335-009
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.47335-010
TadalafilTadalafil 10 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.47335-011
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.47335-012
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7390
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7391
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-8047
TadalafilTadalafil 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-8157
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1884
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-541
TadalafilTadalafil 2.5 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-542
TadalafilTadalafil 10 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-543
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-544

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