Prescription drug · ANDA
Colesevelam hydrochloride NDC 67877-523
Colesevelam hydrochloride 3.75 g/1 · Powder, For suspension · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-523-30 | 6787705233067877052330 | 30 POWDER, FOR SUSPENSION in 1 PACKET (67877-523-30)Marketed from May 9, 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 hydrochloride
- Generic name (nonproprietary)
- colesevelam hydrochloride
- Active ingredients
- Colesevelam hydrochloride — 3.75 g/1
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- Ascend Laboratories, LLCNDC labeler code 67877
- 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 67877-523_28be90eb-5090-4aba-ae6e-8a4332ccfbe2SPL ID 28be90eb-5090-4aba-ae6e-8a4332ccfbe2SPL set ID dfce5bc5-58fc-4fe5-b5c0-7a8026ee2b96RxCUI 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
N467877052330followed by a unit qualifier and the quantityPackage 67877-0523-30. 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 heterozygous familial hypercholesterolemia (HeFH), unable to reach LDL-C target levels despite an adequate trial of diet and lifestyle modification ( 1.1 ). Limitations of Use ( 1.3 ): Do not use for treatment of type 1 diabetes or for diabetic ketoacidosis. Not studied in Fredrickson Type I, III, IV, and V dyslipidemias 1.1 Primary Hyperlipidemia Colesevelam hydrochloride for oral suspension is indicated a…
Excerpt only. Read the full label for complete information.
About NDC 67877-523
- What is NDC 67877-523?
- 67877-523 is the product NDC for Colesevelam hydrochloride, Colesevelam hydrochloride 3.75 g/1 powder, for suspension, listed with the FDA by Ascend Laboratories, LLC. 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?
- Ascend Laboratories, LLC, NDC labeler code 67877. 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 | Bryant Ranch Prepack | 63629-8860 |
| Colesevelam hydrochloride | Colesevelam hydrochloride 3.75 g/1 | Powder, For suspensionOral | Bryant Ranch Prepack | 72162-1847 |