What is NDC 68382-619?

68382-619 is the product NDC for Colesevelam, Colesevelam hydrochloride 625 mg/1 tablet, film coated, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Colesevelam NDC 68382-619 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-619Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0619Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
68382-619-10	6838206191068382061910	1000 TABLET, FILM COATED in 1 BOTTLE (68382-619-10)Marketed from Oct 11, 2019
68382-619-28	6838206192868382061928	180 TABLET, FILM COATED in 1 BOTTLE (68382-619-28)Marketed from Oct 11, 2019
68382-619-77	6838206197768382061977	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
Labeler: Zydus Pharmaceuticals USA Inc.NDC labeler code 68382
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207765
Marketing start: Oct 11, 2019
Listing expires: Dec 31, 2027
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

N468382061910 followed by a unit qualifier and the quantity

Package 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

Current FDA label (SPL), effective Sep 27, 2025.

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. 1.1 Primary Hyperlipidemia …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68382-619

What is NDC 68382-619?: 68382-619 is the product NDC for Colesevelam, Colesevelam hydrochloride 625 mg/1 tablet, film coated, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Colesevelam.
What is the active ingredient?: Colesevelam hydrochloride.
Who is the labeler?: Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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?: 1 other product NDC are listed under this name. See all Colesevelam NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Colesevelam NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Colesevelam	Colesevelam hydrochloride 625 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1368	70771-1368-0070771-1368-0470771-1368-08

Other NDCs under ANDA 207765

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 207765
Product	Strength	Form · route	Labeler	Product NDC
Colesevelam	Colesevelam hydrochloride 625 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1368