NDC codes

FDA NDC Directory
Product NDC (as listed)31722-403Labeler and product segments. Claims need a package NDC.
Product NDC at billing width31722-0403Add 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
31722-403-60317220403603172204036060 CAPSULE in 1 BOTTLE (31722-403-60)Marketed from May 27, 2025

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 — .008 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Camber Pharmaceuticals, Inc.NDC labeler code 31722
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 218640
Marketing start
Listing expires
Other FDA classes
Chloride Channel Activators (Mechanism)
Identifiers
Product ID 31722-403_5008a4ec-08c5-4d06-bac9-e7239620a07dSPL ID 5008a4ec-08c5-4d06-bac9-e7239620a07dSPL set ID 6d973d7d-a43e-4495-b618-a8ad3142683dRxCUI 616578, 794639UNII 7662KG2R6KUPC 0331722404600, 0331722403603
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

N431722040360 followed by a unit qualifier and the quantity

Package 31722-0403-60. 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

Current FDA label (SPL), effective .

Indications (excerpt from the label)

1. INDICATIONS AND USAGE Lubiprostone capsules is a chloride channel activator indicated for the treatment of: chronic idiopathic constipation (CIC) in adults. (1.1) opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. (1.2) o Limitations of Use: Effectiveness of lubiprostone capsules in the treatment of OIC in patients taking diphenylheptane opioids (e.g., methadone) has not been established. (1.2, 7.1) irritable bowel syndrome with constipation (IBS-C) in women ≥18 years old. (1.3) 1.1 Chronic Idiopathic Constipatio…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 31722-403

What is NDC 31722-403?
31722-403 is the product NDC for Lubiprostone, Lubiprostone .008 mg/1 capsule, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Lubiprostone.
What is the active ingredient?
Lubiprostone.
Who is the labeler?
Camber Pharmaceuticals, Inc., NDC labeler code 31722. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Lubiprostone?
37 other product NDCs are listed under this name. See all Lubiprostone 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 Lubiprostone NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
LubiprostoneLubiprostone 8 ug/1Capsule, Gelatin coatedOralAmerican Health Packaging60687-81660687-0816-32
LubiprostoneLubiprostone 24 ug/1Capsule, Gelatin coatedOralAmerican Health Packaging60687-82760687-0827-32
LubiprostoneLubiprostone .008 mg/1CapsuleOralNorthstar Rx LLC72603-28872603-0288-01
LubiprostoneLubiprostone .024 mg/1CapsuleOralNorthstar Rx LLC72603-28972603-0289-01
LubiprostoneLubiprostone .024 mg/1CapsuleOralCamber Pharmaceuticals, Inc.31722-40431722-0404-60
LubiprostoneLubiprostone 24 ug/1Capsule, Gelatin coatedOralDirect Rx72189-60772189-0607-60
LubiprostoneLubiprostone 8 ug/1Capsule, Gelatin coatedOralSpecGx LLC0406-640800406-6408-60
LubiprostoneLubiprostone 24 ug/1Capsule, Gelatin coatedOralSpecGx LLC0406-642400406-6424-60
LubiprostoneLubiprostone 8 ug/1Capsule, Gelatin coatedOralAdvanced Rx of Tennessee, LLC80425-035480425-0354-02
LubiprostoneLubiprostone 24 ug/1Capsule, Gelatin coatedOralAdvanced Rx of Tennessee, LLC80425-035580425-0355-02

All 38 Lubiprostone NDCs

Other NDCs under ANDA 218640

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

FDA NDC Directory listings under ANDA 218640
ProductStrengthForm · routeLabelerProduct NDC
LubiprostoneLubiprostone .024 mg/1CapsuleOralCamber Pharmaceuticals, Inc.31722-404
LubiprostoneLubiprostone .008 mg/1CapsuleOralNorthstar Rx LLC72603-288
LubiprostoneLubiprostone .024 mg/1CapsuleOralNorthstar Rx LLC72603-289

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