What is NDC 46708-178?

46708-178 is the product NDC for Tadalafil, Tadalafil 5 mg/1 tablet, coated, listed with the FDA by Alembic Pharmaceuticals Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.

Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tadalafil NDC 46708-178 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-178Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0178Add 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 NDC	11-digit (billing)	Package
46708-178-15	4670801781546708017815	30 TABLET, COATED in 1 CARTON (46708-178-15)Marketed from Mar 26, 2019
46708-178-30	4670801783046708017830	30 TABLET, COATED in 1 BOTTLE (46708-178-30)Marketed from Mar 26, 2019
46708-178-71	4670801787146708017871	500 TABLET, COATED in 1 BOTTLE (46708-178-71)Marketed from Aug 2, 2024
46708-178-91	4670801789146708017891	1000 TABLET, COATED in 1 BOTTLE (46708-178-91)Marketed from Aug 2, 2024

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, Coated
Route: Oral
Labeler: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204809
Marketing start: Mar 26, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers: Product ID 46708-178_53d81162-1774-48a1-b19b-f2b0e2d1020aSPL ID 53d81162-1774-48a1-b19b-f2b0e2d1020aSPL set ID 741102c1-8809-44d4-9098-3dc8c0604764RxCUI 402019, 403957, 484814, 757707UNII 742SXX0ICTUPC 0346708178307, 0346708180300
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

N446708017815 followed by a unit qualifier and the quantity

Package 46708-0178-15. 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 Sep 5, 2024.

Indications (excerpt from the label)

Tadalafil tablets USP 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 USP 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 USP are indicated for the treatment of erectile dysfunction (ED). 1.2 Benign Prostatic Hyperplasia Tadalafil tablets USP are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). 1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia T…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46708-178

What is NDC 46708-178?: 46708-178 is the product NDC for Tadalafil, Tadalafil 5 mg/1 tablet, coated, listed with the FDA by Alembic Pharmaceuticals Limited. It has 4 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?: Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tadalafil	Tadalafil 2.5 mg/1	Tablet, Film coatedOral	NorthStar Rx, LLC	72603-781	72603-0781-01
Tadalafil	Tadalafil 5 mg/1	Tablet, Film coatedOral	NorthStar Rx, LLC	72603-782	72603-0782-01
Tadalafil	Tadalafil 10 mg/1	Tablet, Film coatedOral	NorthStar Rx, LLC	72603-783	72603-0783-01
Tadalafil	Tadalafil 20 mg/1	Tablet, Film coatedOral	NorthStar Rx, LLC	72603-784	72603-0784-01
Tadalafil	Tadalafil 5 mg/1	TabletOral	REMEDYREPACK INC.	70518-4605	70518-4605-00
tadalafil	Tadalafil 20 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4083	68788-4083-0168788-4083-0368788-4083-07
Tadalafil	Tadalafil 20 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-8039	50090-8039-0050090-8039-0150090-8039-02
Tadalafil	Tadalafil 2.5 mg/1	Tablet, Film coatedOral	Umedica Laboratories USA Inc.	60290-027	60290-0027-0160290-0027-0260290-0027-03+1 more
Tadalafil	Tadalafil 5 mg/1	Tablet, Film coatedOral	Umedica Laboratories USA Inc.	60290-028	60290-0028-0160290-0028-0260290-0028-03+1 more
Tadalafil	Tadalafil 10 mg/1	Tablet, Film coatedOral	Umedica Laboratories USA Inc.	60290-029	60290-0029-0160290-0029-0260290-0029-03+1 more

All 243 Tadalafil NDCs

Other NDCs under ANDA 204809

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

FDA NDC Directory listings under ANDA 204809
Product	Strength	Form · route	Labeler	Product NDC
Tadalafil	Tadalafil 2.5 mg/1	Tablet, CoatedOral	Alembic Pharmaceuticals Limited	46708-177
Tadalafil	Tadalafil 10 mg/1	Tablet, CoatedOral	Alembic Pharmaceuticals Limited	46708-179
Tadalafil	Tadalafil 20 mg/1	Tablet, CoatedOral	Alembic Pharmaceuticals Limited	46708-180
Tadalafil	Tadalafil 2.5 mg/1	Tablet, CoatedOral	Alembic Pharmaceuticals Inc.	62332-177
Tadalafil	Tadalafil 5 mg/1	Tablet, CoatedOral	Alembic Pharmaceuticals Inc.	62332-178
Tadalafil	Tadalafil 10 mg/1	Tablet, CoatedOral	Alembic Pharmaceuticals Inc.	62332-179
Tadalafil	Tadalafil 20 mg/1	Tablet, CoatedOral	Alembic Pharmaceuticals Inc.	62332-180