What is NDC 70771-1368?

70771-1368 is the product NDC for Colesevelam, Colesevelam hydrochloride 625 mg/1 tablet, listed with the FDA by Zydus Lifesciences Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.

Zydus Lifesciences Limited, NDC labeler code 70771. 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 70771-1368 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70771-1368Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70771-1368Add 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
70771-1368-0	7077113680070771136800	1000 TABLET in 1 BOTTLE (70771-1368-0)Marketed from Oct 11, 2019
70771-1368-4	7077113680470771136804	10 BLISTER PACK in 1 CARTON (70771-1368-4) / 10 TABLET in 1 BLISTER PACK (70771-1368-2)Marketed from Oct 11, 2019
70771-1368-8	7077113680870771136808	180 TABLET in 1 BOTTLE (70771-1368-8)Marketed from Oct 11, 2019

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
Generic name (nonproprietary): colesevelam
Active ingredients: Colesevelam hydrochloride — 625 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Zydus Lifesciences LimitedNDC labeler code 70771
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 70771-1368_8bd17f3d-9ca2-4ce2-93a1-b4e9d8571079SPL ID 8bd17f3d-9ca2-4ce2-93a1-b4e9d8571079SPL set ID 090eabd5-acd3-43ed-a05b-52f1f3773a93RxCUI 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

N470771136800 followed by a unit qualifier and the quantity

Package 70771-1368-00. 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 Nov 26, 2024.

Full label on DailyMed (opens in a new tab)

About NDC 70771-1368

What is NDC 70771-1368?: 70771-1368 is the product NDC for Colesevelam, Colesevelam hydrochloride 625 mg/1 tablet, listed with the FDA by Zydus Lifesciences Limited. 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 Lifesciences Limited, NDC labeler code 70771. 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	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	68382-619	68382-0619-1068382-0619-2868382-0619-77

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	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	68382-619