What is NDC 63629-2287?

63629-2287 is the product NDC for Ursodiol, Ursodiol 500 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, 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 Ursodiol?

43 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ursodiol NDC 63629-2287 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-2287Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-2287Add 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	Copy
63629-2287-1	63629228701	100 TABLET, FILM COATED in 1 BOTTLE (63629-2287-1)Marketed from Mar 29, 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): Ursodiol
Generic name (nonproprietary): ursodiol
Active ingredients: Ursodiol — 500 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Bryant Ranch PrepackNDC labeler code 63629
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202540
Marketing start: Aug 1, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Bile Acids and Salts (Chemical structure)
Identifiers: Product ID 63629-2287_d32fbeaf-e133-46c6-ad82-f0f7c8c1009dSPL ID d32fbeaf-e133-46c6-ad82-f0f7c8c1009dSPL set ID 5e6ced5f-b8ef-4e6b-a7c1-730bac650c5bRxCUI 858733UNII 724L30Y2QR
Pharmacologic class: Bile Acid

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

N463629228701 followed by a unit qualifier and the quantity

Package 63629-2287-01. 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 Dec 7, 2023.

Indications (excerpt from the label)

Ursodiol Tablets, USP are indicated for the treatment of patients with primary biliary cirrhosis (PBC). Ursodiol tablets, USP are bile acids indicated for the treatment of patients with primary biliary cirrhosis ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-2287

What is NDC 63629-2287?: 63629-2287 is the product NDC for Ursodiol, Ursodiol 500 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Ursodiol.
What is the active ingredient?: Ursodiol.
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 Ursodiol?: 43 other product NDCs are listed under this name. See all Ursodiol 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 Ursodiol NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ursodiol	Ursodiol 300 mg/1	CapsuleOral	AvPAK	50268-864	50268-0864-13
Ursodiol	Ursodiol 300 mg/1	CapsuleOral	NorthStar Rx LLC	72603-613	72603-0613-01
Ursodiol	Ursodiol 250 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-2633	55154-2633-00
Ursodiol	Ursodiol 500 mg/1	Tablet, Film coatedOral	AvKARE	42291-931	42291-0931-01
Ursodiol	Ursodiol 300 mg/1	CapsuleOral	AvKARE	42291-923	42291-0923-01
Ursodiol	Ursodiol 300 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2619	72162-2619-01
Ursodiol	Ursodiol 300 mg/1	CapsuleOral	Aurobindo Pharma Limited	59651-421	59651-0421-01
Ursodiol	Ursodiol 300 mg/1	CapsuleOral	PuraCap Laboratories, LLC	24658-999	24658-0999-10
Ursodiol	Ursodiol 300 mg/1	CapsuleOral	Strides Pharma Science Limited	64380-844	64380-0844-0464380-0844-0664380-0844-07
Ursodiol	Ursodiol 300 mg/1	CapsuleOral	Laurus Labs Limited	42385-946	42385-0946-01

All 44 Ursodiol NDCs

Other NDCs under ANDA 202540

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

FDA NDC Directory listings under ANDA 202540
Product	Strength	Form · route	Labeler	Product NDC
Ursodiol	Ursodiol 250 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6890
Ursodiol	Ursodiol 250 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-1500
Ursodiol	Ursodiol 500 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-1501
Ursodiol	Ursodiol 250 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-2633
Ursodiol	Ursodiol 500 mg/1	Tablet, Film coatedOral	AvKARE	42291-931
Ursodiol	Ursodiol 250 mg/1	Tablet, Film coatedOral	Par Health USA, LLC	49884-412
Ursodiol	Ursodiol 500 mg/1	Tablet, Film coatedOral	Par Health USA, LLC	49884-413
Ursodiol	Ursodiol 250 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-2286