Prescription drug · ANDA
Colesevelam hydrochloride NDC 63629-8860
Colesevelam hydrochloride 3.75 g/1 · Powder, For suspension · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8860-1 | 6362988600163629886001 | 30 PACKET in 1 CARTON (63629-8860-1) / 1 POWDER, FOR SUSPENSION in 1 PACKETMarketed from Aug 19, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 hydrochloride
- Generic name (nonproprietary)
- colesevelam hydrochloride
- Active ingredients
- Colesevelam hydrochloride — 3.75 g/1
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210316
- Marketing start
- Listing expires
- Other FDA classes
- Bile-acid Binding Activity (Mechanism)
- Identifiers
- Product ID 63629-8860_ea570adf-f7b9-4e17-a7db-92e9f70a1dbeSPL ID ea570adf-f7b9-4e17-a7db-92e9f70a1dbeSPL set ID 652fbd7b-2702-4db6-8691-be93c61bd9d6RxCUI 866905UNII 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
N463629886001followed by a unit qualifier and the quantityPackage 63629-8860-01. 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)
Colesevelam hydrochloride is a bile acid sequestrant indicated as an adjunct to diet and exercise to: reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia ( 1.1 ). reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heteroz ygous familial hypercholesterolemia (HeFH) ( 1.1 ). Limitations of Use ( 1.3 ): Do not use for treatment of type 1 diabetes or for diabetic ketoacidosis. The effect on cardiovascular morbidity and mortality has not been determined. Not studied in type 2 diabetes with a dipeptidyl peptidase 4 inhibitor. Not studied in Fredrickson Type I, III, IV, and V dyslipidemias. Not studied in children less than…
Excerpt only. Read the full label for complete information.
About NDC 63629-8860
- What is NDC 63629-8860?
- 63629-8860 is the product NDC for Colesevelam hydrochloride, Colesevelam hydrochloride 3.75 g/1 powder, for suspension, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Colesevelam hydrochloride.
- What is the active ingredient?
- Colesevelam hydrochloride.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 63629. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Colesevelam hydrochloride?
- 20 other product NDCs are listed under this name. See all Colesevelam hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Colesevelam hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Colesevelam Hydrochloride | Colesevelam hydrochloride 625 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-582 | 69452-0582-25 |
| Colesevelam Hydrochloride | Colesevelam hydrochloride 625 mg/1 | TabletOral | Bionpharma Inc. | 69452-493 | 69452-0493-25 |
| Colesevelam Hydrochloride | Colesevelam hydrochloride 625 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-197 | 33342-0197-57 |
| Colesevelam hydrochloride | Colesevelam hydrochloride 3.75 g/1 | For suspensionOral | Amneal Pharmaceuticals of New York LLC | 0115-1864 | 00115-1864-18 |
| Colesevelam Hydrochloride | Colesevelam hydrochloride 625 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6994 | 50090-6994-00 |
| Colesevelam Hydrochloride | Colesevelam hydrochloride 625 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6995 | 50090-6995-00 |
| Colesevelam hydrochloride | Colesevelam hydrochloride 625 mg/1 | TabletOral | Cranbury Pharmaceuticals, LLC | 27808-190 | 27808-0190-01 |
| Colesevelam hydrochloride | Colesevelam hydrochloride 625 mg/1 | TabletOral | A-S Medication Solutions | 50090-7604 | 50090-7604-00 |
| Colesevelam hydrochloride | Colesevelam hydrochloride 625 mg/1 | TabletOral | A-S Medication Solutions | 50090-7605 | 50090-7605-00 |
| Colesevelam Hydrochloride | Colesevelam hydrochloride 625 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-336 | 51407-0336-18 |
Other NDCs under ANDA 210316
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 |
|---|---|---|---|---|
| Colesevelam hydrochloride | Colesevelam hydrochloride 3.75 g/1 | Powder, For suspensionOral | Ascend Laboratories, LLC | 67877-523 |
| Colesevelam hydrochloride | Colesevelam hydrochloride 3.75 g/1 | Powder, For suspensionOral | Bryant Ranch Prepack | 72162-1847 |