Prescription drug · ANDA
Ursodiol 200 mg (Ursodiol) NDC 72887-143
Ursodiol 200 mg/1 · Capsule · Oral · FH2 Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72887-143-06 | 72887014306 | 60 CAPSULE in 1 BOTTLE (72887-143-06)Marketed from Nov 18, 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)
- Ursodiol 200 mg
- Generic name (nonproprietary)
- ursodiol
- Active ingredients
- Ursodiol — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- FH2 Pharma LLCNDC labeler code 72887
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205789
- Marketing start
- Listing expires
- Other FDA classes
- Bile Acids and Salts (Chemical structure)
- Identifiers
- Product ID 72887-143_c28d41e2-14c2-4401-87ab-49b32239cabaSPL ID c28d41e2-14c2-4401-87ab-49b32239cabaSPL set ID 476179dc-b410-4305-881b-470511765647RxCUI 412174, 2376942UNII 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
N472887014306followed by a unit qualifier and the quantityPackage 72887-0143-06. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE 1. Ursodiol 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 ursodiol beyond 24 months is not established. 2. Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.
Excerpt only. Read the full label for complete information.
About NDC 72887-143
- What is NDC 72887-143?
- 72887-143 is the product NDC for Ursodiol 200 mg (ursodiol), Ursodiol 200 mg/1 capsule, listed with the FDA by FH2 Pharma LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ursodiol 200 mg (Ursodiol).
- What is the active ingredient?
- Ursodiol.
- Who is the labeler?
- FH2 Pharma LLC, NDC labeler code 72887. 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 200 mg?
- 1 other product NDC are listed under this name. See all Ursodiol 200 mg NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ursodiol 200 mg products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ursodiol 200 mgusodiol | Ursodiol 200 mg/1 | CapsuleOral | LGM PHARMA SOLUTIONS, LLC | 79739-7143 | 79739-7143-01 |
Other NDCs under ANDA 205789
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| 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 |
| Ursodiol 200 mgusodiol | Ursodiol 200 mg/1 | CapsuleOral | LGM PHARMA SOLUTIONS, LLC | 79739-7143 |
| Reltone 400 mgursodiol | Ursodiol 400 mg/1 | CapsuleOral | Intra-Sana Laboratories | 80056-144 |
| Reltone 200 mgursodiol | Ursodiol 200 mg/1 | CapsuleOral | Intra-Sana Laboratories | 80056-143 |