Prescription drug · ANDA
Colesevelam NDC 68382-619
Colesevelam hydrochloride 625 mg/1 · Tablet, Film coated · Oral · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68382-619-10 | 68382061910 | 1000 TABLET, FILM COATED in 1 BOTTLE (68382-619-10)Marketed from Oct 11, 2019 | |
| 68382-619-28 | 68382061928 | 180 TABLET, FILM COATED in 1 BOTTLE (68382-619-28)Marketed from Oct 11, 2019 | |
| 68382-619-77 | 68382061977 | 10 BLISTER PACK in 1 CARTON (68382-619-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-619-30)Marketed from Oct 11, 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)
- Colesevelam
- Generic name (nonproprietary)
- colesevelam
- Active ingredients
- Colesevelam hydrochloride — 625 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207765
- Marketing start
- Listing expires
- Other FDA classes
- Bile-acid Binding Activity (Mechanism)
- Identifiers
- Product ID 68382-619_bf6a10ac-0317-4804-a504-cd00e522dc65SPL ID bf6a10ac-0317-4804-a504-cd00e522dc65SPL set ID 6a26e745-7e38-4af0-9bcc-566b2812df75RxCUI 866910UNII P4SG24WI5Q
- Pharmacologic class
- Bile Acid Sequestrant
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
N468382061910followed by a unit qualifier and the quantityPackage 68382-0619-10. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.