NDC codes

FDA NDC Directory
Product NDC (as listed)70771-1477Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70771-1477Add 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
70771-1477-070771147700707711477001000 TABLET, FILM COATED in 1 BOTTLE (70771-1477-0)Marketed from Mar 27, 2019
70771-1477-17077114770170771147701100 TABLET, FILM COATED in 1 BOTTLE (70771-1477-1)Marketed from Mar 27, 2019
70771-1477-3707711477037077114770330 TABLET, FILM COATED in 1 BOTTLE (70771-1477-3)Marketed from Mar 27, 2019
70771-1477-470771147704707711477042 BLISTER PACK in 1 CARTON (70771-1477-4) / 15 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Mar 27, 2019
70771-1477-57077114770570771147705500 TABLET, FILM COATED in 1 BOTTLE (70771-1477-5)Marketed from Mar 27, 2019
70771-1477-9707711477097077114770990 TABLET, FILM COATED in 1 BOTTLE (70771-1477-9)Marketed from Mar 27, 2019

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
Zydus Lifesciences LimitedNDC labeler code 70771
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206693
Marketing start
Listing expires
Other FDA classes
Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers
Product ID 70771-1477_89266030-a1a1-4825-b9f0-9400886b6282SPL ID 89266030-a1a1-4825-b9f0-9400886b6282SPL set ID 6c1c3a1f-80a4-417c-8830-5edbb9a0710fRxCUI 402019, 403957, 484814, 757707UNII 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

N470771147700 followed by a unit qualifier and the quantity

Package 70771-1477-00. 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 .

Full label on DailyMed (opens in a new tab)

About NDC 70771-1477

What is NDC 70771-1477?
70771-1477 is the product NDC for Tadalafil, Tadalafil 10 mg/1 tablet, film coated, listed with the FDA by Zydus Lifesciences Limited. 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?
Zydus Lifesciences Limited, NDC labeler code 70771. 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 206693

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

FDA NDC Directory listings under ANDA 206693
ProductStrengthForm · routeLabelerProduct NDC
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-063
TadalafilTadalafil 2.5 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.68382-896
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.68382-897
TadalafilTadalafil 10 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.68382-898
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.68382-899
TadalafilTadalafil 2.5 mg/1Tablet, Film coatedOralZydus Lifesciences Limited70771-1475
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralZydus Lifesciences Limited70771-1476
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralZydus Lifesciences Limited70771-1478

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