What is NDC 63629-8288?

63629-8288 is the product NDC for Tadalafil, Tadalafil 5 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 4 package NDCs, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 63629. 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 63629-8288 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-8288Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-8288Add 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
63629-8288-1	63629828801	30 TABLET in 1 BOTTLE (63629-8288-1)Marketed from Jun 13, 2022
63629-8288-2	63629828802	90 TABLET in 1 BOTTLE (63629-8288-2)Marketed from Mar 10, 2023
63629-8288-3	63629828803	15 TABLET in 1 BOTTLE (63629-8288-3)Marketed from Feb 22, 2021
63629-8288-4	63629828804	60 TABLET in 1 BOTTLE (63629-8288-4)Marketed from Feb 22, 2021

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 — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Bryant Ranch PrepackNDC labeler code 63629
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209654
Marketing start: Mar 26, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers: Product ID 63629-8288_08531412-01c1-4053-93b6-83f785a873cdSPL ID 08531412-01c1-4053-93b6-83f785a873cdSPL set ID 185a3284-3a4f-44d3-9278-98581d33f95bRxCUI 403957UNII 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

N463629828801 followed by a unit qualifier and the quantity

Package 63629-8288-01. 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 Aug 8, 2024.

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 is 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 indicated…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-8288

What is NDC 63629-8288?: 63629-8288 is the product NDC for Tadalafil, Tadalafil 5 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. 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?: Bryant Ranch Prepack, NDC labeler code 63629. 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 209654

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

FDA NDC Directory listings under ANDA 209654
Product	Strength	Form · route	Labeler	Product NDC
Tadalafil	Tadalafil 2.5 mg/1	TabletOral	Ajanta Pharma USA Inc.	27241-111
Tadalafil	Tadalafil 5 mg/1	TabletOral	Ajanta Pharma USA Inc.	27241-112
Tadalafil	Tadalafil 10 mg/1	TabletOral	Ajanta Pharma USA Inc.	27241-113
Tadalafil	Tadalafil 20 mg/1	TabletOral	Ajanta Pharma USA Inc.	27241-114
Tadalafil	Tadalafil 20 mg/1	TabletOral	A-S Medication Solutions	50090-5641
Tadalafil	Tadalafil 20 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-2421
Tadalafil	Tadalafil 10 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-2554
Tadalafil	Tadalafil 20 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-2632
Tadalafil	Tadalafil 2.5 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3540
Tadalafil	Tadalafil 5 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8292
Tadalafil	Tadalafil 20 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8445
Tadalafil	Tadalafil 5 mg/1	TabletOral	REMEDYREPACK INC.	70518-3434
Tadalafil	Tadalafil 20 mg/1	TabletOral	REMEDYREPACK INC.	70518-4534
Tadalafil	Tadalafil 5 mg/1	TabletOral	Proficient Rx LP	71205-734
Tadalafil	Tadalafil 10 mg/1	TabletOral	Proficient Rx LP	71205-735
Tadalafil	Tadalafil 20 mg/1	TabletOral	Proficient Rx LP	71205-736
Tadalafil	Tadalafil 20 mg/1	TabletOral	Bryant Ranch Prepack	71335-1491
Tadalafil	Tadalafil 10 mg/1	TabletOral	Bryant Ranch Prepack	71335-1670
Tadalafil	Tadalafil 2.5 mg/1	TabletOral	Bryant Ranch Prepack	71335-1823
Tadalafil	Tadalafil 5 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-461

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