NDC codes

FDA NDC Directory
Product NDC (as listed)43598-168Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43598-0168Add 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
43598-168-604359801686060 CAPSULE, GELATIN COATED in 1 BOTTLE (43598-168-60)Marketed from Jan 1, 2023

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)
Lubiprostone
Generic name (nonproprietary)
lubiprostone
Active ingredients
Lubiprostone — 24 ug/1
Dosage form
Capsule, Gelatin coated
Route
Oral
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 021908
Marketing start
Listing expires
Other FDA classes
Chloride Channel Activators (Mechanism)
Identifiers
Product ID 43598-168_8f55941d-f7c6-4a16-ae76-c2cd1ab7d607SPL ID 8f55941d-f7c6-4a16-ae76-c2cd1ab7d607SPL set ID 006b8b6c-f0eb-4246-87da-67582984b0e4RxCUI 616578, 794639UNII 7662KG2R6K
Pharmacologic class
Chloride Channel Activator

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

N443598016860 followed by a unit qualifier and the quantity

Package 43598-0168-60. 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 NDA 021908

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

FDA NDC Directory listings under NDA 021908
ProductStrengthForm · routeLabelerProduct NDC
LubiprostoneLubiprostone 8 ug/1Capsule, Gelatin coatedOralPar Health USA, LLC0254-3028
LubiprostoneLubiprostone 8 ug/1Capsule, Gelatin coatedOralSun Pharmaceutical Industries, Inc.63304-351
LubiprostoneLubiprostone 8 ug/1Capsule, Gelatin coatedOralGolden State Medical Supply, Inc.51407-744
LubiprostoneLubiprostone 24 ug/1Capsule, Gelatin coatedOralSun Pharmaceutical Industries, Inc.63304-352
LubiprostoneLubiprostone 24 ug/1Capsule, Gelatin coatedOralGolden State Medical Supply, Inc.51407-745
LubiprostoneLubiprostone 24 ug/1Capsule, Gelatin coatedOralPar Health USA, LLC0254-3029
LubiprostoneLubiprostone 8 ug/1Capsule, Gelatin coatedOralNatco Pharma USA LLC69339-162
LubiprostoneLubiprostone 24 ug/1Capsule, Gelatin coatedOralNatco Pharma USA LLC69339-163
AmitizalubiprostoneLubiprostone 8 ug/1Capsule, Gelatin coatedOralTakeda Pharmaceuticals America, Inc.64764-080
AmitizalubiprostoneLubiprostone 24 ug/1Capsule, Gelatin coatedOralTakeda Pharmaceuticals America, Inc.64764-240
LubiprostoneLubiprostone 24 ug/1Capsule, Gelatin coatedOralProficient Rx LP82804-001
LubiprostoneLubiprostone 8 ug/1Capsule, Gelatin coatedOralSpecGx LLC0406-6408
LubiprostoneLubiprostone 24 ug/1Capsule, Gelatin coatedOralSpecGx LLC0406-6424
LubiprostoneLubiprostone 24 ug/1Capsule, Gelatin coatedOralAdvanced Rx of Tennessee, LLC80425-0355
LubiprostoneLubiprostone 8 ug/1Capsule, Gelatin coatedOralAdvanced Rx of Tennessee, LLC80425-0354
LubiprostoneLubiprostone 8 ug/1Capsule, Gelatin coatedOralDr. Reddy's Laboratories Inc.43598-163
LubiprostoneLubiprostone 24 ug/1Capsule, Gelatin coatedOralDirect Rx72189-607
AmitizalubiprostoneLubiprostone 8 ug/1Capsule, Gelatin coatedOralSpecGx LLC23635-508
AmitizalubiprostoneLubiprostone 24 ug/1Capsule, Gelatin coatedOralSpecGx LLC23635-524
LubiprostoneLubiprostone 24 ug/1Capsule, Gelatin coatedOralProficient Rx LP71205-834

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