Prescription drug · ANDA
Colesevelam HCL NDC 67877-506
Colesevelam hydrochloride 625 mg/1 · Tablet, Film coated · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-506-05 | 6787705060567877050605 | 500 TABLET, FILM COATED in 1 BOTTLE (67877-506-05)Marketed from Oct 6, 2018 | |
| 67877-506-30 | 6787705063067877050630 | 30 TABLET, FILM COATED in 1 BOTTLE (67877-506-30)Marketed from Oct 6, 2018 | |
| 67877-506-51 | 6787705065167877050651 | 180 TABLET, FILM COATED in 1 BOTTLE (67877-506-51)Marketed from Oct 6, 2018 | |
| 67877-506-90 | 6787705069067877050690 | 90 TABLET, FILM COATED in 1 BOTTLE (67877-506-90)Marketed from Oct 6, 2018 |
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 HCL
- Generic name (nonproprietary)
- colesevelam hcl
- Active ingredients
- Colesevelam hydrochloride — 625 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Ascend Laboratories, LLCNDC labeler code 67877
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209038
- Marketing start
- Listing expires
- Other FDA classes
- Bile-acid Binding Activity (Mechanism)
- Identifiers
- Product ID 67877-506_1505e4ef-7340-4164-b3f2-cdd36a67f92bSPL ID 1505e4ef-7340-4164-b3f2-cdd36a67f92bSPL set ID 4ffd02a3-86b8-4af7-b539-aa32e38c6b12RxCUI 866910UNII P4SG24WI5QUPC 0367877506517
- 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
N467877050605followed by a unit qualifier and the quantityPackage 67877-0506-05. 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 ). • improve glycemic control in adults with type 2 diabetes mellitus ( 1.2 ). 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…
Excerpt only. Read the full label for complete information.
About NDC 67877-506
- What is NDC 67877-506?
- 67877-506 is the product NDC for Colesevelam HCL, Colesevelam hydrochloride 625 mg/1 tablet, film coated, listed with the FDA by Ascend Laboratories, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Colesevelam HCL.
- 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 HCL?
- 6 other product NDCs are listed under this name. See all Colesevelam HCL NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Colesevelam HCL 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 HCL | Colesevelam hydrochloride 625 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4371 | 50090-4371-00 |
| Colesevelam HCL | Colesevelam hydrochloride 625 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7811 | 50090-7811-00 |
| Colesevelam HCL | Colesevelam hydrochloride 625 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-8767 | 63629-8767-01 |
| Colesevelam HCL | Colesevelam hydrochloride 625 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2905 | 71335-2905-01 |
| Colesevelam HCL | Colesevelam hydrochloride 625 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1846 | 72162-1846-02 |
| Colesevelam HCL | Colesevelam hydrochloride 625 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-476 | 72789-0476-93 |
Other NDCs under ANDA 209038
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 HCL | Colesevelam hydrochloride 625 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4371 |
| Colesevelam HCL | Colesevelam hydrochloride 625 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7811 |
| Colesevelam HCL | Colesevelam hydrochloride 625 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-8767 |
| Colesevelam HCL | Colesevelam hydrochloride 625 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2905 |
| Colesevelam HCL | Colesevelam hydrochloride 625 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1846 |
| Colesevelam HCL | Colesevelam hydrochloride 625 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-476 |