NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1620Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1620Add 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
71335-1620-1713351620017133516200130 TABLET, FILM COATED in 1 BOTTLE (71335-1620-1)Marketed from Jun 24, 2020
71335-1620-2713351620027133516200210 TABLET, FILM COATED in 1 BOTTLE (71335-1620-2)Marketed from Aug 20, 2020
71335-1620-3713351620037133516200360 TABLET, FILM COATED in 1 BOTTLE (71335-1620-3)Marketed from Jan 13, 2021
71335-1620-4713351620047133516200490 TABLET, FILM COATED in 1 BOTTLE (71335-1620-4)Marketed from Jun 3, 2020
71335-1620-5713351620057133516200520 TABLET, FILM COATED in 1 BOTTLE (71335-1620-5)Marketed from Oct 31, 2024
71335-1620-671335162006713351620066 TABLET, FILM COATED in 1 BOTTLE (71335-1620-6)Marketed from Oct 31, 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 — 10 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 209167
Marketing start
Listing expires
Other FDA classes
Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers
Product ID 71335-1620_c7f976f4-9d3b-4c8e-b4ae-3270ba8d8a00SPL ID c7f976f4-9d3b-4c8e-b4ae-3270ba8d8a00SPL set ID f8def23c-55ea-4796-9735-dbcb25104835RxCUI 484814UNII 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

N471335162001 followed by a unit qualifier and the quantity

Package 71335-1620-01. 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-1620

What is NDC 71335-1620?
71335-1620 is the product NDC for Tadalafil, Tadalafil 10 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 6 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 209167

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

FDA NDC Directory listings under ANDA 209167
ProductStrengthForm · routeLabelerProduct NDC
TadalafilTadalafil 2.5 mg/1Tablet, Film coatedOralAccord Healthcare Inc.16729-369
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralAccord Healthcare Inc.16729-370
TadalafilTadalafil 10 mg/1Tablet, Film coatedOralAccord Healthcare Inc.16729-371
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralAccord Healthcare Inc.16729-372
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6150
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-473
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-487
TadalafilTadalafil 2.5 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-8409
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-2553
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-5186
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-5202
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8153
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralProficient Rx LP71205-268
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralProficient Rx LP71205-269
TadalafilTadalafil 10 mg/1Tablet, Film coatedOralProficient Rx LP71205-502
TadalafilTadalafil 10 mg/1Tablet, Film coatedOralProficient Rx LP71205-720
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1587
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-126

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