What is NDC 43386-071?

43386-071 is the product NDC for GaviLyte-H and Bisacodyl kit, listed with the FDA by Lupin Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

GaviLyte-H and Bisacodyl (Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride and Bisacodyl Delayed-release Tablet).

Lupin Pharmaceuticals, Inc., NDC labeler code 43386. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for GaviLyte-H and Bisacodyl?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

GaviLyte-H and Bisacodyl NDC 43386-071

NDC codes

FDA NDC Directory

Product NDC (as listed)43386-071Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43386-0071Add 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	Copy
43386-071-83	4338600718343386007183	1 KIT in 1 KIT (43386-071-83) * 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (43386-010-61) * 2 L in 1 BOTTLE (43386-070-17)Marketed from Apr 21, 2015

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): GaviLyte-H and Bisacodyl
Generic name (nonproprietary): polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride and bisacodyl delayed-release tablet
Dosage form: Kit
Route: Oral
Labeler: Lupin Pharmaceuticals, Inc.NDC labeler code 43386
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202217
Marketing start: Apr 21, 2015
Listing expires: Dec 31, 2027
Identifiers: Product ID 43386-071_c34cfe17-96c2-4f07-8a2d-74bc84e61fb4SPL ID c34cfe17-96c2-4f07-8a2d-74bc84e61fb4SPL set ID 78fe1c29-e22a-4615-a2f9-a61cd4eb38a3RxCUI 308753, 1000479, 1718983, 1718990, 1718991UPC 0343386205028

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

N443386007183 followed by a unit qualifier and the quantity

Package 43386-0071-83. 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 Jan 28, 2025.

Indications (excerpt from the label)

GaviLyte - H and bisacodyl delayed-release tablet, USP is indicated for cleansing of the colon as a preparation for colonoscopy in adults. GaviLyte - H and bisacodyl delayed-release tablet, USP is a combination of PEG-3350, an osmotic laxative and bisacodyl, a stimulant laxative, indicated for cleansing of the colon as a preparation for colonoscopy in adults ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43386-071

What is NDC 43386-071?: 43386-071 is the product NDC for GaviLyte-H and Bisacodyl kit, listed with the FDA by Lupin Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: GaviLyte-H and Bisacodyl (Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride and Bisacodyl Delayed-release Tablet).
Who is the labeler?: Lupin Pharmaceuticals, Inc., NDC labeler code 43386. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for GaviLyte-H and Bisacodyl?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.