NDC codes

FDA NDC Directory
Product NDC (as listed)70771-1763Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70771-1763Add 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
70771-1763-17077117630170771176301100 CAPSULE in 1 BOTTLE (70771-1763-1)Marketed from Mar 23, 2023
70771-1763-6707711763067077117630660 CAPSULE in 1 BOTTLE (70771-1763-6)Marketed from Mar 23, 2023

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)
Lubiprostone
Generic name (nonproprietary)
lubiprostone
Active ingredients
Lubiprostone — 8 ug/1
Dosage form
Capsule
Route
Oral
Labeler
Zydus Lifesciences LimitedNDC labeler code 70771
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214131
Marketing start
Listing expires
Other FDA classes
Chloride Channel Activators (Mechanism)
Identifiers
Product ID 70771-1763_570c527a-5ee5-4950-b27a-48f652af549fSPL ID 570c527a-5ee5-4950-b27a-48f652af549fSPL set ID 81f9c9de-f89d-4ab0-a8ca-18d3691e42f9RxCUI 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

N470771176301 followed by a unit qualifier and the quantity

Package 70771-1763-01. 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

Current FDA label (SPL), effective .

Full label on DailyMed (opens in a new tab)

About NDC 70771-1763

What is NDC 70771-1763?
70771-1763 is the product NDC for Lubiprostone, Lubiprostone 8 ug/1 capsule, listed with the FDA by Zydus Lifesciences Limited. It has 2 package NDCs, 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?
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 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 .008 mg/1CapsuleOralCamber Pharmaceuticals, Inc.31722-40331722-0403-60
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

All 38 Lubiprostone NDCs

Other NDCs under ANDA 214131

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

FDA NDC Directory listings under ANDA 214131
ProductStrengthForm · routeLabelerProduct NDC
LubiprostoneLubiprostone 8 ug/1CapsuleOralZydus Pharmaceuticals USA Inc.70710-1641
LubiprostoneLubiprostone 24 ug/1CapsuleOralZydus Pharmaceuticals USA Inc.70710-1642
LubiprostoneLubiprostone 24 ug/1CapsuleOralZydus Lifesciences Limited70771-1764
LubiprostoneLubiprostone 8 ug/1CapsuleOralAsclemed USA, Inc.76420-777
LubiprostoneLubiprostone 24 ug/1CapsuleOralAsclemed USA, Inc.76420-778

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