Prescription drug · ANDA
Ursodiol (ursosiol) NDC 43063-871
Ursadiol 300 mg/1 · Capsule · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-871-01 | 43063087101 | 100 CAPSULE in 1 BOTTLE, PLASTIC (43063-871-01)Marketed from Jul 26, 2018 | |
| 43063-871-60 | 43063087160 | 60 CAPSULE in 1 BOTTLE, PLASTIC (43063-871-60)Marketed from Dec 10, 2019 | |
| 43063-871-93 | 43063087193 | 180 CAPSULE in 1 BOTTLE, PLASTIC (43063-871-93)Marketed from Dec 10, 2019 |
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
- Generic name (nonproprietary)
- ursosiol
- Active ingredients
- Ursadiol — 300 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210707
- Marketing start
- Listing expires
- Identifiers
- Product ID 43063-871_3a2162b5-df74-1461-e063-6394a90a5e81SPL ID 3a2162b5-df74-1461-e063-6394a90a5e81SPL set ID d89c9e1e-a115-4a01-9275-74d6cd8cf285RxCUI 858747UNII 3D089V7L0KUPC 0343063871010
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
N443063087101followed by a unit qualifier and the quantityPackage 43063-0871-01. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Ursodiol Capsules are 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 capsules beyond 24 months is not established. Ursodiol capsules are indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210707
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 |
|---|---|---|---|---|
| Ursodiolursosiol | Ursadiol 300 mg/1 | CapsuleOral | KVK-Tech, Inc. | 10702-237 |