Prescription drug · ANDA
colesevelam hydrochloride NDC 68462-433
Colesevelam hydrochloride 625 mg/1 · Tablet, Film coated · Oral · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-433-18 | 6846204331868462043318 | 180 TABLET, FILM COATED in 1 BOTTLE (68462-433-18)Marketed from May 18, 2018 | |
| 68462-433-90 | 6846204339068462043390 | 90 TABLET, FILM COATED in 1 BOTTLE (68462-433-90)Marketed from May 18, 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 hydrochloride
- Generic name (nonproprietary)
- colesevelam hydrochloride
- Active ingredients
- Colesevelam hydrochloride — 625 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203480
- Marketing start
- Listing expires
- Other FDA classes
- Bile-acid Binding Activity (Mechanism)
- Identifiers
- Product ID 68462-433_169fb7d2-7872-46a4-99ab-94f46781348fSPL ID 169fb7d2-7872-46a4-99ab-94f46781348fSPL set ID 845b8661-0aa9-418f-a496-df3d7a3130ffRxCUI 866910UNII P4SG24WI5QUPC 0368462433188
- 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
N468462043318followed by a unit qualifier and the quantityPackage 68462-0433-18. 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 tablets are 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 dyslipid…
Excerpt only. Read the full label for complete information.
About NDC 68462-433
- What is NDC 68462-433?
- 68462-433 is the product NDC for colesevelam hydrochloride, Colesevelam hydrochloride 625 mg/1 tablet, film coated, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 2 package NDCs, 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?
- Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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 203480
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 625 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7459 |
| colesevelam hydrochloride | Colesevelam hydrochloride 625 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7460 |