What is NDC 80056-143?

80056-143 is the product NDC for Reltone 200 mg (ursodiol), Ursodiol 200 mg/1 capsule, listed with the FDA by Intra-Sana Laboratories. It has 1 package NDC, shown above in 10- and 11-digit form.

Intra-Sana Laboratories, NDC labeler code 80056. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Reltone 200 mg?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Reltone 200 mg NDC 80056-143 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80056-143Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80056-0143Add 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
80056-143-01	80056014301	100 CAPSULE in 1 BOTTLE (80056-143-01)Marketed from Feb 15, 2021

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): Reltone 200 mg
Generic name (nonproprietary): ursodiol
Active ingredients: Ursodiol — 200 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Intra-Sana LaboratoriesNDC labeler code 80056
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205789
Marketing start: Jul 1, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Bile Acids and Salts (Chemical structure)
Identifiers: Product ID 80056-143_1fc18c67-20db-4fe5-bc22-2772f0788d13SPL ID 1fc18c67-20db-4fe5-bc22-2772f0788d13SPL set ID d1c28b0b-8f3c-4d60-8182-24a4c659d762RxCUI 412174, 2376942, 2477896, 2477898UNII 724L30Y2QRUPC 0380056144010, 0380056143013
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

N480056014301 followed by a unit qualifier and the quantity

Package 80056-0143-01. 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 Jan 16, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE 1. Reltone™ is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of Reltone™ beyond 24 months is not established. 2. Reltone™ is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80056-143

What is NDC 80056-143?: 80056-143 is the product NDC for Reltone 200 mg (ursodiol), Ursodiol 200 mg/1 capsule, listed with the FDA by Intra-Sana Laboratories. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Reltone 200 mg (Ursodiol).
What is the active ingredient?: Ursodiol.
Who is the labeler?: Intra-Sana Laboratories, NDC labeler code 80056. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Reltone 200 mg?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 205789

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

FDA NDC Directory listings under ANDA 205789
Product	Strength	Form · route	Labeler	Product NDC
Reltone 400 mgursodiol	Ursodiol 400 mg/1	CapsuleOral	Intra-Sana Laboratories	80056-144
Ursodiol 200 mgursodiol	Ursodiol 200 mg/1	CapsuleOral	FH2 Pharma LLC	72887-143
Ursodiol 200 mgusodiol	Ursodiol 200 mg/1	CapsuleOral	LGM PHARMA SOLUTIONS, LLC	79739-7143
Ursodiol 400 mgursodiol	Ursodiol 400 mg/1	CapsuleOral	FH2 Pharma LLC	72887-144
Ursodiol 400 mgusodiol	Ursodiol 400 mg/1	CapsuleOral	LGM PHARMA SOLUTIONS, LLC	79739-7144

Reltone 200 mg (Ursodiol) NDC 80056-143