NDC codes

FDA NDC Directory
Product NDC (as listed)43386-917Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43386-0917Add 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 NDC11-digit (billing)PackageCopy
43386-917-0143386091701100 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-917-01)Marketed from Jan 21, 2016
43386-917-0543386091705500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-917-05)Marketed from Jan 30, 2017
43386-917-10433860917101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-917-10)Marketed from Jan 30, 2017

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)
Potassium Chloride
Generic name (nonproprietary)
potassium chloride
Active ingredients
Potassium chloride — 20 meq/1
Dosage form
Tablet, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206347
Marketing start
Listing expires
Other FDA classes
Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Osmotic Activity (Mechanism)Potassium Compounds (Chemical structure)
Identifiers
Product ID 43386-917_a056d531-3e7b-4598-a042-0d498456be72SPL ID a056d531-3e7b-4598-a042-0d498456be72SPL set ID fe08221d-74d5-490a-8db4-eaf3ed20b289RxCUI 1801294, 1801298UNII 660YQ98I10
Pharmacologic class
Osmotic Laxative; Potassium Salt

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

N443386091701 followed by a unit qualifier and the quantity

Package 43386-0917-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 206347

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

FDA NDC Directory listings under ANDA 206347
ProductStrengthForm · routeLabelerProduct NDC
Potassium ChloridePotassium chloride 10 meq/1Tablet, Extended releaseOralLupin Pharmaceuticals,Inc.43386-915

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