Prescription drug · ANDA
Ursodiol NDC 60687-527
Ursodiol 250 mg/1 · Tablet · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-527-21 | 6068705272160687052721 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-527-21) / 1 TABLET in 1 BLISTER PACK (60687-527-11)Marketed from Sep 11, 2020 |
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)
- ursodiol
- Active ingredients
- Ursodiol — 250 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- American Health PackagingNDC labeler code 60687
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211145
- Marketing start
- Listing expires
- Other FDA classes
- Bile Acids and Salts (Chemical structure)
- Identifiers
- Product ID 60687-527_437ecc8a-2e45-94a1-e063-6394a90acc85SPL ID 437ecc8a-2e45-94a1-e063-6394a90acc85SPL set ID a3a90d07-0dac-48fc-829a-759d9333843eRxCUI 858751UNII 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
N460687052721followed by a unit qualifier and the quantityPackage 60687-0527-21. 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)
Ursodiol tablets 250 mg and 500 mg are indicated for the treatment of patients with primary biliary cholangitis (PBC). Ursodiol tablets 250 mg and 500 mg are bile acids indicated for the treatment of patients with primary biliary cholangitis. (1)
Excerpt only. Read the full label for complete information.
About NDC 60687-527
- What is NDC 60687-527?
- 60687-527 is the product NDC for Ursodiol, Ursodiol 250 mg/1 tablet, listed with the FDA by American Health Packaging. 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?
- American Health Packaging, NDC labeler code 60687. 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.
Related NDCs: other Ursodiol 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 | 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 |
Other NDCs under ANDA 211145
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 | Ursodiol 250 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1127 |
| Ursodiol | Ursodiol 500 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1128 |
| Ursodiol | Ursodiol 250 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1407 |
| Ursodiol | Ursodiol 500 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1408 |