NDC codes

FDA NDC Directory
Product NDC (as listed)71205-754Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71205-0754Add 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
71205-754-10712050754107120507541010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-754-10)Marketed from Jan 31, 2023
71205-754-20712050754207120507542020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-754-20)Marketed from Jan 31, 2023
71205-754-30712050754307120507543030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-754-30)Marketed from Jan 31, 2023
71205-754-60712050754607120507546060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-754-60)Marketed from Jan 31, 2023
71205-754-90712050754907120507549090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-754-90)Marketed from Jan 31, 2023

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
Proficient Rx LPNDC labeler code 71205
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209250
Marketing start
Listing expires
Other FDA classes
Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers
Product ID 71205-754_ac93704f-8e33-43ba-8b56-3d61092ff1d9SPL ID ac93704f-8e33-43ba-8b56-3d61092ff1d9SPL set ID ac93704f-8e33-43ba-8b56-3d61092ff1d9RxCUI 403957UNII 742SXX0ICTUPC 0371205754303
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

N471205075410 followed by a unit qualifier and the quantity

Package 71205-0754-10. 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 Tablets 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 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 71205-754

What is NDC 71205-754?
71205-754 is the product NDC for tadalafil, Tadalafil 5 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 5 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?
Proficient Rx LP, NDC labeler code 71205. 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 209250

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

FDA NDC Directory listings under ANDA 209250
ProductStrengthForm · routeLabelerProduct NDC
tadalafilTadalafil 2.5 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-286
tadalafilTadalafil 5 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-287
tadalafilTadalafil 10 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-288
tadalafilTadalafil 20 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-289
tadalafilTadalafil 10 mg/1Tablet, Film coatedOralRedpharm Drug67296-2237
tadalafilTadalafil 5 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-3586
tadalafilTadalafil 20 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-3777
tadalafilTadalafil 20 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-4083
tadalafilTadalafil 5 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2467
tadalafilTadalafil 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2583
tadalafilTadalafil 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-3175
tadalafilTadalafil 2.5 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-854
tadalafilTadalafil 5 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-855
tadalafilTadalafil 10 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-856
tadalafilTadalafil 20 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-857
tadalafilTadalafil 20 mg/1Tablet, Film coatedOralProficient Rx LP82804-112
tadalafilTadalafil 10 mg/1Tablet, Film coatedOralProficient Rx LP82804-224

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