What is NDC 80425-0355?

80425-0355 is the product NDC for Lubiprostone, Lubiprostone 24 ug/1 capsule, gelatin coated, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Advanced Rx of Tennessee, LLC, NDC labeler code 80425. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Lubiprostone NDC 80425-0355 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0355Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0355Add 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
80425-0355-2	8042503550280425035502	60 CAPSULE, GELATIN COATED in 1 BOTTLE (80425-0355-2)Marketed from Aug 16, 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 — 24 ug/1
Dosage form: Capsule, Gelatin coated
Route: Oral
Labeler: Advanced Rx of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 021908
Marketing start: Aug 16, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Chloride Channel Activators (Mechanism)
Identifiers: Product ID 80425-0355_2a999573-102f-813a-e063-6294a90a49b1SPL ID 2a999573-102f-813a-e063-6294a90a49b1SPL set ID 031149b9-c709-de1f-e063-6394a90a6d81RxCUI 616578UNII 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

N480425035502 followed by a unit qualifier and the quantity

Package 80425-0355-02. 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 Dec 31, 2024.

Indications (excerpt from the label)

Lubiprostone 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 ) Limitations of Use: Effectiveness of lubiprostone 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 Constipation in Adults Lubiprostone is indicat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0355

What is NDC 80425-0355?: 80425-0355 is the product NDC for Lubiprostone, Lubiprostone 24 ug/1 capsule, gelatin coated, listed with the FDA by Advanced Rx of Tennessee, LLC. 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?: Advanced Rx of Tennessee, LLC, NDC labeler code 80425. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Lubiprostone	Lubiprostone 8 ug/1	Capsule, Gelatin coatedOral	American Health Packaging	60687-816	60687-0816-32
Lubiprostone	Lubiprostone 24 ug/1	Capsule, Gelatin coatedOral	American Health Packaging	60687-827	60687-0827-32
Lubiprostone	Lubiprostone .008 mg/1	CapsuleOral	Northstar Rx LLC	72603-288	72603-0288-01
Lubiprostone	Lubiprostone .024 mg/1	CapsuleOral	Northstar Rx LLC	72603-289	72603-0289-01
Lubiprostone	Lubiprostone .008 mg/1	CapsuleOral	Camber Pharmaceuticals, Inc.	31722-403	31722-0403-60
Lubiprostone	Lubiprostone .024 mg/1	CapsuleOral	Camber Pharmaceuticals, Inc.	31722-404	31722-0404-60
Lubiprostone	Lubiprostone 24 ug/1	Capsule, Gelatin coatedOral	Direct Rx	72189-607	72189-0607-60
Lubiprostone	Lubiprostone 8 ug/1	Capsule, Gelatin coatedOral	SpecGx LLC	0406-6408	00406-6408-60
Lubiprostone	Lubiprostone 24 ug/1	Capsule, Gelatin coatedOral	SpecGx LLC	0406-6424	00406-6424-60
Lubiprostone	Lubiprostone 8 ug/1	Capsule, Gelatin coatedOral	Advanced Rx of Tennessee, LLC	80425-0354	80425-0354-02

All 38 Lubiprostone NDCs

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
Product	Strength	Form · route	Labeler	Product NDC
Amitizalubiprostone	Lubiprostone 8 ug/1	Capsule, Gelatin coatedOral	SpecGx LLC	23635-508
Amitizalubiprostone	Lubiprostone 24 ug/1	Capsule, Gelatin coatedOral	SpecGx LLC	23635-524
Amitizalubiprostone	Lubiprostone 8 ug/1	Capsule, Gelatin coatedOral	Takeda Pharmaceuticals America, Inc.	64764-080
Amitizalubiprostone	Lubiprostone 24 ug/1	Capsule, Gelatin coatedOral	Takeda Pharmaceuticals America, Inc.	64764-240
Lubiprostone	Lubiprostone 8 ug/1	Capsule, Gelatin coatedOral	Par Health USA, LLC	0254-3028
Lubiprostone	Lubiprostone 24 ug/1	Capsule, Gelatin coatedOral	Par Health USA, LLC	0254-3029
Lubiprostone	Lubiprostone 8 ug/1	Capsule, Gelatin coatedOral	SpecGx LLC	0406-6408
Lubiprostone	Lubiprostone 24 ug/1	Capsule, Gelatin coatedOral	SpecGx LLC	0406-6424
Lubiprostone	Lubiprostone 8 ug/1	Capsule, Gelatin coatedOral	Dr. Reddy's Laboratories Inc.	43598-163
Lubiprostone	Lubiprostone 24 ug/1	Capsule, Gelatin coatedOral	Dr. Reddy's Laboratories Inc.	43598-168
Lubiprostone	Lubiprostone 8 ug/1	Capsule, Gelatin coatedOral	Golden State Medical Supply, Inc.	51407-744
Lubiprostone	Lubiprostone 24 ug/1	Capsule, Gelatin coatedOral	Golden State Medical Supply, Inc.	51407-745
Lubiprostone	Lubiprostone 8 ug/1	Capsule, Gelatin coatedOral	Sun Pharmaceutical Industries, Inc.	63304-351
Lubiprostone	Lubiprostone 24 ug/1	Capsule, Gelatin coatedOral	Sun Pharmaceutical Industries, Inc.	63304-352
Lubiprostone	Lubiprostone 8 ug/1	Capsule, Gelatin coatedOral	Natco Pharma USA LLC	69339-162
Lubiprostone	Lubiprostone 24 ug/1	Capsule, Gelatin coatedOral	Natco Pharma USA LLC	69339-163
Lubiprostone	Lubiprostone 8 ug/1	Capsule, Gelatin coatedOral	Proficient Rx LP	71205-831
Lubiprostone	Lubiprostone 24 ug/1	Capsule, Gelatin coatedOral	Proficient Rx LP	71205-832
Lubiprostone	Lubiprostone 24 ug/1	Capsule, Gelatin coatedOral	Proficient Rx LP	71205-834
Lubiprostone	Lubiprostone 24 ug/1	Capsule, Gelatin coatedOral	Direct Rx	72189-607

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